Food, Drug, and Device

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Covington’s internationally leading Food, Drug, and Device Practice encompasses the full range of pharmaceutical, biotechnology, medical device, veterinary, food and beverage, dietary supplement, and cosmetics issues. Through our offices in the United States, Europe, and China and a network of local counsel, we advise trade associations, multinational corporations, and emerging companies on a global basis. We are the only firm ranked “Band 1” for Life Sciences across Chambers’ US, UK, Europe, China, and Global surveys.

In the United States, we represent pharmaceutical, biotechnology, and medical device clients on matters spanning the product life cycle, from product development and clinical trials, through the FDA premarket review process, to postmarketing compliance, including adverse event reporting, Good Manufacturing Practice (GMP) and Quality System requirements, and sales and marketing. We also advise clients on complex issues relating to Hatch-Waxman, biosimilars, and orphan products. As a result of our long and deep work in the area, Covington lawyers have extensive knowledge of the governing laws and regulations, broad-based practical experience with their application, and an intimate knowledge of government regulators and enforcement authorities.

We assist clients in all aspects of food and beverage product development, safety, labeling, and promotion, and have played a key role in the most important legislative developments in the food arena, including advising clients on every new FSMA rulemaking and FDA guidance issued to date. We also have a preeminent regulatory practice relating to veterinary pharmaceuticals, veterinary biological products, pet food, and animal feed. We advise the principal trade association and numerous companies on regulation of cosmetic products.

Our London and Brussels offices include more than twenty-five lawyers who are qualified in various European Union (EU) member states and speak the main languages of the EU. We advise clients on the full range of issues involving pharmaceuticals, biotechnology, devices and diagnostics, foods, cosmetics, and borderline products. We advise on life cycle management planning, pharmacovigilance, EMA transparency policies, and the classification, conformity assessment, and CE marking of medical devices in Europe. We participate in pricing and reimbursement proceedings, including appeals against negative recommendations by the UK’s National Institute of Health and Clinical Excellence, and have in-depth expertise in the EU chemical regime (REACH), which has a significant downstream impact on consumer and health products.

We handle regulatory matters before the European Commission, the European Medicines Agency (EMA), and national regulatory agencies in the European Union. We have actively participated in the development of key pharmaceutical legislation in Europe, and we represent clients in connection with new legislative and regulatory initiatives, including new Medical Device Regulations, Clinical Trials Regulation, Transparency Directive on pricing and reimbursement, and legislation on information to patients.

Our China regulatory team plays a significant role in the firm’s global practice. Our attorneys in Asia and the United States regularly counsel national and multinational companies on the regulatory requirements of the China FDA and provincial FDA authorities. We advise on major developments in the law, regulation, and policy-making processes, including changes to the regulatory frameworks governing food safety, medical devices, pharmaceuticals, and cosmetics, and assist with regulatory advocacy during the notice and comment process before the China FDA.

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Legislative Victory in a 2016 FDA Nutrition Facts Panel Rule

When the 2016 Nutrition Facts Panel final rule required manufacturers to submit evidence demonstrating that their products met new standards, our client, a Midwestern food ingredients company, immediately complied. However, they were told the FDA would not be able to review the data in time to renew the company’s contracts. Faced with losing its domestic customers for its flagship products, we organized a robust appropriations strategy involving a series of high-level communications. Through our efforts, the FDA delayed compliance long enough to allow for due process. The company was able to swiftly renew its contracts with its biggest customers.

Deep experience

We have represented clients in numerous other congressional investigations and oversight hearings, including a major internet services company in an investigation of its practices abroad, a chemical manufacturer in an investigation of the safety of its products, an insurance company in a hearing on the federal long term care insurance program, a financial services company in an investigation of credit card terms, and drug companies in investigations concerning such matters as payments to doctors, marketing practices, generic approvals, drug importation, and drug safety.

AstraZeneca/Bristol-Myers Squibb diabetes alliance

Representation of AstraZeneca in its strategic diabetes alliance with Bristol-Myers Squibb, including with respect to collaboration arrangements for the development and commercialization of Amylin Pharmaceuticals’ portfolio of diabetes products following BMS’s acquisition of Amylin in a deal valued at $7 billion (approximately half the cost of which was borne by AstraZeneca).

AstraZeneca in $1.26 Billion Acquisition of Ardea Biosciences

Representation of AstraZeneca in its $1.26 billion acquisition of Ardea Biosciences. Under the agreement, AstraZeneca will pay $32 per share for all of the outstanding shares of Ardea. AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. Ardea is a biotechnology company based in San Diego, California, focused on the development of small-molecule therapeutics for the treatment of serious diseases.

Biopharmaceutical Legislation Representation

Representation of coalition of innovative biopharmaceutical manufacturers during the multi-year process that led to enactment of the Biologics Price Competition and Innovation Act of 2010 (BPCIA). Played a similar role for the pharmaceutical industry prior to enactment of the Hatch-Waxman amendments of 1984. Currently advising members of the pharmaceutical industry on FDA regulatory aspects of 21st Century Cures Act and the Senate’s Innovation for Healthier Americans initiative.

In re K-Dur Antitrust Litigation

Representing Schering-Plough (now Merck) in multi-district class action litigation challenging so-called reverse payment settlements of pharmaceutical patent litigation. Obtained denial of certification of indirect purchaser class, after which indirect purchasers voluntarily dismissed their case. The team previously defeated the FTC at trial in an action on the same facts, and will now have the opportunity to resolve the direct purchaser portion of the case under a recent Supreme Court decision.

Over-the-counter medicine investigation

We represented a world-leading consumer products manufacturer in an investigation by the House Committee on Oversight and Government Reform regarding high-profile recalls of over-the-counter medicines. The investigation included multiple interviews, tens of thousands of documents produced to Congress, and two major hearings, including one at which the company’s chairman and CEO testified.

Numerous Clients in Managing U.S. and Global Trademark Portfolios

Advise on cutting edge trademark strategies, domain name, social media, and keyword advertising issues, manage U.S. and global portfolios, and provided trademark advisory and prosecution services to leading US and global brand owners, including: American Automobile Association (AAA); AOL, Inc.; Astelllas US; Business Software Alliance; Dale & Thomas Popcorn; Expedia, Inc.; FeraDyne Outdoors; German American Chambers of Commerce; Lewis Bakeries, Inc.; Merck & Co. Inc.; Microsoft Corporation; National Basketball Association; National Football League; National Geographic Society; National Hockey League; Public Broadcasting Service; Phi Beta Kappa Society; Promontory Financial Group; and U.S. Soccer Federation.

Representation of an international beverage company in LCIA and UNCITRAL arbitrations

Representation of a leading Caribbean-based international beverage company in an LCIA arbitration against the former controlling shareholders of a major European-based company that was acquired by our client and in successfully handling a London-sited UNCITRAL arbitration administered by the LCIA.

Salix Pharmaceuticals in $2.6 Billion of Santarus, Inc.

Representation of Salix Pharmaceuticals, Ltd. in its acquisition of Santarus, Inc. for a total value of approximately $2.6 billion. The transaction closed on January 2, 2014. According to Carolyn Logan, Salix President and Chief Executive Officer, “The acquisition of Santarus is a transformational event for Salix and an important milestone in our growth as the leading gastroenterology-focused specialty pharmaceutical company in the United States.”

Advice to Numerous Life Sciences Companies on Regulatory Compliance and Infrastructure

Advice to numerous pharmaceutical and medical technology companies on compliance with with pharmaceutical and medical device regulations. For pharmaceutical companies, this has included compliance with manufacturing and supply chain rules, pharmacovigilance, and other “GxP” requirements. We have advised device manufacturers on borderline, classification, conformity assessment and other quality system requirements, including in the digital health space. In both industries, we have advised extensively on the impact of, and preparations for Brexit.

Victory for BMS and Eli Lilly in Copyright Infringement Matter

Secured a sweeping victory for our clients BMS and Eli Lilly. In 2006, BMS/Lilly hired Consumer Health Information Corporation (“CHIC”) to develop patient education materials for their injectable diabetes drug BYETTA. The contract expressly designated these as works made for hire and assigned CHIC’s interest in these materials to BMS/Lilly. BMS/Lilly later terminated CHIC, and CHIC sued for copyright infringement in D.C. district court in 2008, but voluntarily dismissed the action in 2009. Last July, CHIC sued again in the Southern District of Indiana. In an attempt to avoid the contractual ownership provisions, CHIC alleged “economic duress” and sought rescission. CHIC's infringement claim sought to recover our clients' profits, allegedly “in excess of several billions of dollars.” Judge Pratt dismissed the complaint with prejudice, ruling that two separate statutes of limitation barred CHIC’s infringement claim. First, the Court held that the claim was barred by the Copyright Act’s three-year statute of limitations. The Court accepted Covington’s argument that, because the case turned on ownership, not use, the continuing violation doctrine did not apply. The Court pointedly noted the inequity of allowing CHIC to wait while BMS/Lilly developed a market only to “pounce on the prize” years later. Separately, the Court held that the ownership provisions expressly assigned ownership to BMS/Lilly, and that CHIC’s attempted rescission was barred by California’s four-year statute of limitations. The Court also rejected CHIC’s outrageous attempt to invoke equitable tolling by arguing that its own (former) attorneys had dismissed its 2008 action without its consent and subsequently concealed the dismissal from CHIC.

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COVID-19: Legal and Business Toolkit

Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are ...

CJEU Confirms that CBD is Not a Narcotic Drug

CJEU Confirms that CBD is Not a Narcotic Drug In a landmark judgment on 19 November 2020, the CJEU ruled in Case C-663/18 that cannabidiol (“CBD”) is not a narcotic drug under the UN Conventions. This is the case even where the CBD is derived from the whole cannabis plant. In this alert we look at how the ruling provides clarity on the non-controlled status of ...

Can We Talk? US FDA Remote Records Review Missteps Worry Industry

Paula Katz is quoted in the Pink Sheet regarding her record requests from the FDA on behalf of her clients. Ms. Katz says clients have asked the firm to reply to the official listed as the contact on the records request and “ask for a teleconference to discuss the request and make sure that the things you’re providing are effective and responding and that you ...

FDA Issues a Draft Guidance on Voluntary Disclosure of Sesame as an Allergen

Yesterday, FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”) issued a draft guidance regarding the voluntary labeling of sesame when used in flavoring or spice or in a food declared by another name, such as tahini. The Federal Register notice will officially be published on Thursday. We briefly summarize the draft guidance below to help inform ...

Key Issues for FDA in a Biden Administration

Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...

FDA Holds Public Meeting on Food Traceability Proposed Rule

On November 6, 2020, the Food and Drug Administration (FDA) held the first of three public meetings regarding its Food Traceability Proposed Rule. The proposed rule, which is required by section 204 of the Food Safety Modernization Act (FSMA), would impose additional traceability recordkeeping requirements on entities that manufacture, process, pack, or hold ...

US Election 2020: What Does A Trump Or Biden Win Mean For FDA Regulations?

Wade Ackerman is quoted in Medtech Insight regarding the impact of the 2020 presidential election on FDA regulations. Mr. Ackerman says the outcome of the election may have a significant effect on the leadership of U.S. FDA, with either winner bringing marked differences in policies and priorities. In a note to clients, he outlined some differences medtech ...

Lawyers: Congress, not FDA, will legalize CBD in supplements

Natural Food Products Insider included Miriam Guggenheim’s remarks from the "Now, New, Next" conference about the legalization of CBD products through Congress, not the FDA. Ms. Guggenheim doubts that FDA would be the one to make CBD a lawful dietary ingredient in supplements. “It will happen from Congress. It’s possible that FDA will make a little clearer ...

The November Election and Implications at the FDA: Key Issues to Watch

The outcome of the national elections next week will have consequential implications at the U.S. Food and Drug Administration (FDA). The election may affect the composition of FDA’s leadership team, and stakeholders can expect differences in policies and priorities between a second Trump Administration and a new Biden Administration. Control of the U.S. Senate ...

China Releases Draft Criminal Law Amendments, Proposing Changes in the Areas of Anti-Corruption, Life Science, and Trade Secrets Protection

On October 21, 2020, China’s National People’s Congress (“NPC”) published revised draft amendments (“Draft Amendments”) to China’s Criminal Law. The legislature will be soliciting public comment until November 19, 2020, and will then review and enact the amendments. Based on previous amendments, we do not expect the final version as enacted to differ ...

FDA Discusses First 100 Days of its “New Era of Smarter Food Safety”

Yesterday, the Food and Drug Administration (FDA) held a webinar to discuss key actions it has taken since releasing its New Era of Smarter Food Safety Blueprint on July 13, 2020. FDA’s New Era of Smarter Food Safety is an initiative that aims to modernize, enhance, and streamline the agency’s approach to food safety through the use of technology and other ...

FDA Finalizes Allulose Guidance and Requests Information on Other Sugars Metabolized Differently Than Traditional Sugars

FDA has taken two notable actions regarding the sugars declaration in the Nutrition Facts Label (NFL) and Supplement Facts Label (SFL). On Friday, the agency released a final guidance regarding the declaration of allulose, confirming that this monosaccharide need not be included in the declaration of “Total Sugars” or “Added Sugars,” though it must be included ...

Cell-Cultured Meat Startups, NAMI, Urge USDA to Gather More Data Before Issuing a Proposed Rule on Labeling

Brian Sylvester is quoted in Food Navigator regarding the USDA’s labeling of cell-cultured meats. Mr. Sylvester says that he didn't think an Advance Notice of Proposed Rulemaking (ANPR) would extend the timeline in a meaningful way. “Instead, it could actually be an efficient means of collecting needed data sooner rather than later to lay the foundation for a ...

FDA Advertising and Promotion Enforcement Activities: Update

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. In September, the Office of Prescription Drug Promotion (OPDP) posted three warning letters on FDA’s website, including ...

What's in a Name? FDA Requests Info on Labeling of Cell-Cultured Seafood

Brian Sylvester spoke with Food Navigator about the labeling of cell-cultured seafood. Mr. Sylvester says, “USDA has not yet invited public comment on the labelling of cell-cultured meat & poultry but is expected to do so in due course. It is reasonable to expect that USDA will ultimately put out a similar request and will collaborate with FDA on reviewing ...

Gerald Masoudi Rejoins Covington

WASHINGTON—Gerald Masoudi, former General Counsel of Celgene Corporation and then JUUL Labs, has rejoined Covington’s Food, Drug, and Device Practice Group in Washington as a partner. Mr. Masoudi has more than 25 years of broad experience in the life sciences industry. He served as Chief Counsel of the U.S. Food and Drug Administration from 2007 to 2009. He ...

Web Of 'Wellness' Doctors Promote Injections Of Unproven Coronavirus Treatment

Julie Dohm is quoted in NPR regarding the use of unproven COVID-19 treatments and compounded drugs. Regarding compounded drugs, Ms. Dohm says, “They are subject to a lower quality standard, and so it's very important that they really only be used when medically necessary.”

HHS and FDA Actions on Importation of Prescription Drugs from Canada and other Countries

On September 24, 2020, the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) took major steps toward facilitating the importation of prescription drugs by entities other than the manufacturer, with the stated goal of lowering costs for American consumers.

FDA Proposes FSMA Food Traceability Rule, Including High-Risk Food Categories

Yesterday, FDA released a proposed rule that, if finalized, would impose additional traceability recordkeeping requirements for certain high-risk foods. This rulemaking is required by section 204 of FSMA, and is an additional action in FDA’s ongoing FSMA implementation. FDA proposes to establish a “Food Traceability List” (FTL) that would enumerate certain foods ...

FDA Releases Guidance on Resuming Normal Drug and Biologics Manufacturing Operations During COVID-19

Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and mitigating ...

Trump Administration Releases, Revokes, and Reissues “Most-Favored-Nation” Executive Order

The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders ...

USDA Updates: FSIS Proposes Significant Updates to Generic Label Approval Oversight, and Finalizes Rules on Modernizing Egg Inspection

The first half of September has seen two major regulatory updates from USDA’s Food Safety and Inspection Service (FSIS). First, on September 14, 2020, FSIS published a proposed rule to expand the circumstances under which FSIS will generically approve the labels of meat, poultry, and egg products, which specifically proposes that FSIS will cease evaluating ...

UK Is Left out of EU Cooperation on Foreign Direct Investment, And Will Soon Be “Foreign”

The EU Regulation on Foreign Direct Investment (2019/452) (the “EU FDI Regulation”) will enter into force fully on October 11, 2020. Most notably, on this date, a cooperation and information sharing mechanism among Member States and the European Commission in respect of foreign direct investment (“FDI”) that has an “EU-dimension” will come into effect.

Legal Experts: HHS Policy Change Strips FDA Of Oversight For All LDTs

Scott Danzis spoke with Medtech Insight about a Department of Health and Human Services announcement stripping the FDA of its oversight over Laboratory Developed Tests, or LDTs. Mr. Danzis says, “By the terms of the policy that was issued, it is not restricted to COVID-19 LDTs. It is broader than that. Moreover, we’ve had recent discussions with senior HHS ...

What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections

Tom Cosgrove is quoted in The Pink Sheet regarding virtual inspections conducted by the FDA during the COVID-19 pandemic. Mr. Cosgrove says, “We were hoping to see some progress on remote or virtual facility inspections.” He notes that the agency has been working hard to avoid the need for pre-approval inspections by, for example, requesting records and talking ...

HHS Issues New LDT Policy, Rescinding FDA Premarket Review Policies

On August 19, the Department of Health and Human Services (HHS) announced a new policy concerning laboratory developed tests (LDTs). Under this policy, HHS has determined that the Food and Drug Administration (FDA) must engage in notice-and-comment rulemaking before requiring premarket review of LDTs. Depending on the next steps from HHS and FDA, this ...

FDA Announces Availability of Temporary Guidance on Manufacturing, Supply Chain, and Drug Inspections During COVID-19

On August 19, FDA announced the availability of a temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers.” FDA issued the guidance to address frequently-asked questions from industry regarding the impacts of the COVID-19 public health ...

Five Things You Need to Know About OEHHA’s Proposed Rule Exempting Acrylamide-by-Cooking From Prop 65

On August 4, 2020, OEHHA, the California agency in charge of Prop 65 announced a proposed regulation that, when final, would exempt from Prop 65 products containing listed chemicals introduced through cooking or heat-processing. Acrylamide has been the most widely targeted chemical created through cooking, but the proposal would also provide a mechanism for ...

USDA Proposes Rule on Strengthening Organic Enforcement

On August 5, 2020, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published a proposed rule that would amend the USDA organic regulations in an effort to strengthen oversight and enforcement of the production, handling, and sale of organic agricultural products. The proposed changes come in response to concerns about the ...

FDA Announces Proposed Rule to Require Veterinary Device Submissions to Customs and Border Protection’s Automated Commercial Environment

On Monday, FDA published for public comment a proposed rule concerning the submission of certain data elements for veterinary devices imported or offered for import via the Automated Commercial Environment (ACE) or other U.S. Customs and Border Protection (CBP)-authorized electronic data interchange (EDI) system.[1] Comments are due by October 19, 2020. The ...

AMS Proposes Updates to its List of Bioengineered Foods

On July 24, 2020, the United States Department of Agriculture’s Agricultural Marketing Service (“AMS”) published proposed updates to its list of bioengineered (“BE”) foods. Under the National Bioengineered Food Disclosure Standard (“NBFDS”), manufacturers, importers, and certain retailers must make a BE disclosure for foods on this list or foods containing ...

FDA Announces Six-Month Extension of Enforcement Discretion Policy for Certain Regenerative Medicine Products

FDA announced this week that it intends to extend its enforcement discretion policy regarding investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products through May 2021. In light of the COVID-19 emergency, manufacturers will have six additional months after the initial November 2020 deadline to prepare and ...

FDA Issues Draft Guidance on Quality Considerations for Clinical Research Involving Cannabis and Cannabis-Derived Compounds

Yesterday, the Food and Drug Administration (FDA) issued draft guidance describing the agency’s thinking on topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. While the draft guidance is limited to drug development and does not address other types of products, some of FDA’s thinking may ...

Dietary Guidelines Advisory Committee Releases Report with Recommendations for the 2020-2025 Dietary Guidelines for Americans

On July 15, the 2020 Dietary Guidelines Advisory Committee (DGAC) released its final report to the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), outlining its recommendations for the 2020-2025 Dietary Guidelines for Americans (Dietary Guidelines). The Dietary Guidelines, a joint effort of HHS and USDA, provide the ...

FDA Launches New ERA for Smarter Food Safety Blueprint

On Monday, FDA rolled out its Blueprint for Smarter Food Safety; Modern Approaches for Modern Times. The Blueprint had been nearly ready for release several months ago, but was delayed when Covid-19 required FDA to divert its resources to responding to the pandemic. The Blueprint is intended to enhance and streamline the prevention of and response to food ...

FDA Submits Report on CBD Marketplace Surveillance to Congress

On July 8, the Food and Drug Administration (FDA) submitted a report to Congress describing the results of the agency’s sampling and testing of products in the CBD marketplace. The Further Consolidated Appropriations Act, 2020 required FDA to perform the study to help determine the extent to which such products are mislabeled or adulterated. In this report, FDA ...

USDA’s AMS Publishes Guidance on BE Testing and Validation of Refining Processes

On July 2, 2020, USDA’s Agricultural Marketing Service (“AMS”) published final guidance documents and FAQs to assist companies in complying with the National Bioengineered (“BE”) Food Disclosure Standard (“NBFDS”). Under the NBFDS, a responsible party need not make a BE disclosure for a BE food if the party can show (1) the food is sourced from a non-BE crop or ...

Covington Represents Piramal in $490M Sale of Stake in Pharmaceutical Unit

WASHINGTON—Covington represented Piramal Enterprises Limited (PEL) in the sale of a 20% stake in Piramal Pharma Limited (Piramal Pharma), a wholly owned subsidiary of PEL that will contain its pharmaceutical businesses, to CA Clover Intermediate II Investments, an affiliated entity of CAP V Mauritius Limited, an investment fund managed and advised by affiliated ...

FDA Releases Guidance on COVID-19 CGMP Considerations for Drug Manufacturers

Drug manufacturers have responded to the COVID-19 pandemic by adopting critical measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, they have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and ...

CBD companies get hit with wave of class action lawsuits

Miriam Guggenheim spoke with Politico about the proliferation of CBD retailers and manufacturers and the wave of recent class-action lawsuits. Ms. Guggenheim says, “It's an area of uncertainty. I do think this is an area where FDA has primary jurisdiction, and the courts should allow at least the questions of the legality of CBD or hemp extracts to be determined ...

BIO 2020: Are We Ready for Decentralized Clinical Trials?

Wade Ackerman is quoted in BioSpace regarding the decentralization of clinical trials in the pharmaceutical industry. Mr. Ackerman says the “all hands on deck” approach to the pandemic by Congress and the FDA set the stage for clinical trial innovation. “It has set up a lot of conversations about where telehealth is, and where it will be six months from now,” he ...

The coronavirus pandemic is reigniting a fierce debate over compounded drugs

Julie Dohm is quoted in STAT News regarding the FDA’s temporary policy allowing smaller pharmacies to make certain drugs for treating COVID-19 without first receiving a patient’s prescription for the drug. The condition for this new policy is that the pharmacies sell the drugs to a hospital that can prove it could not source the drugs from elsewhere. Ms. Dohm ...

Wade Ackerman and Amy Toro Named Top Health Care Lawyers

LOS ANGELES—Daily Journal has named Wade Ackerman and Amy Toro to its 2020 Top Health Care Lawyers, a recognition of the leading California lawyers who specialize in health care litigation, transactions, and counselling. Mr. Ackerman, a partner in our Los Angeles office, advises clients on complex FDA issues that require coordinated legal, regulatory, and public ...

Eleventh Circuit Rejects "Fear of Glyphosate" Claim for Lack of Standing

On May 20, 2020, the Eleventh Circuit in Doss v. General Mills, Inc. held that a consumer who bought a box of Cheerios containing allegedly "ultra-low levels of glyphosate" lacked Article III standing to sue General Mills. "Fear of Glyphosate" class actions against food manufacturers of this type have become increasingly common. While Doss is unpublished, it is ...

Opening the Doors: Return-to-Workplace Considerations During COVID-19 - EU Regulatory

Businesses are developing plans for reopening workplaces. As they do, many employers are considering ways to determine which employees can safely return to the workplace, and what protective equipment should be provided to employees once they return. In the European Union (EU) and United Kingdom (UK), many of the products used in these strategies are regulated ...

FDA Updates Hand Sanitizer Enforcement Discretion Guidance to Provide More Information Regarding Ethanol Sourcing

Today, FDA issued updates to its guidance document "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),"("Temporary Policy") and related guidance document, that primarily provide more detailed information about potential ethanol sources for companies seeking to prepare hand sanitizer or ...

Pharma panics as Washington pushes to bring drug manufacturing back to the U.S.

Thomas Cosgrove is quoted in STAT News regarding the cost for U.S. pharmaceutical companies to produce drugs domestically. Mr. Cosgrove says, “What would it take the supply chain to come all the way back to the U.S.? It’s simple: It will take decades and billions.”

FDA Grants Flexibility for Minor Changes to Labeled Ingredients

On May 22, 2020, FDA issued a temporary policy permitting manufacturers to use existing labels even if they need to make minor ingredient changes due to supply chain disruptions caused by the COVID-19 public health emergency. Limited shortages and other disruptions in the supply of food ingredients have already occurred, and manufacturers may experience ...

FDA and USDA Publish MOU to Prevent Interruptions at FDA-Regulated Food Facilities

Earlier this week, FDA and USDA issued a Memorandum of Understanding (“MOU”) establishing how the two agencies will communicate and collaborate with respect to the potential invocation of the Defense Production Act (“DPA”). The agreement outlines how the agencies will determine whether USDA will exercise its presidentially-delegated DPA authorities over ...

Second Circuit Uses Preemption to Extinguish Slack-Fill Class Action

Slack-fill class actions have been proliferating. The vagaries of the definition of “nonfunctional slack fill” have made food, candy, and cosmetics manufacturers easy prey. But after the Second Circuit’s May 11 decision in Critcher v. L’Oréal USA Inc., slack-fill claims against cosmetics manufacturers will be harder to bring. Courts are now more likely to find ...

U.S. business takes on burden of testing employees for coronavirus

Christopher Hanson is quoted in the Financial Times regarding the private sector’s undertaking of COVID-19 testing for its employees. Mr. Hanson notes that diagnostic testing “presents an array of regulatory considerations” in the U.S., such as checking whether a test has been approved by regulators. He says that even in the U.S. “the landscape is changing ...

USDA APHIS Animal Care Finalizes Revised Licensing Regulations

Last week, the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture, through the Deputy Administrator for Animal Care (Animal Care), published its final revised regulations for licensing dealers, exhibitors, and operators of auction sales under the Animal Welfare Act, 7 U.S.C. §§ 2131, et seq. (AWA). The revised ...

FDA Issues New Guidance for Development of COVID-19 Drugs and Biological Products

On May 11, 2020, the U.S. Food and Drug Administration (“FDA”) issued new guidance on the development of drugs and biologics to treat or prevent COVID-19: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (“Pre-IND Guidance”) and COVID-19: Developing Drugs and Biological ...

Opening the Doors: Return-to-Workplace Considerations During COVID-19

Businesses are developing plans for reopening workplaces. As they do, many employers are considering ways to determine which employees can safely return to the workplace, and what protective equipment should be provided to employees once they return. In both the United States and European Union, many of the products used in these strategies are regulated as ...

CMS Finalizes Rule Expressly Permitting Copay Accumulator Programs

On May 7, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced that it had finalized the Notice of Benefit and Payment Parameters for 2021 (“2021 NBPP Final Rule”). The final rule, which will go into effect on July 13, 2020, expressly allows certain health plans to determine, to the extent permitted by state law, whether to count pharmaceutical ...

First Circuit Revives Claim That “100% Natural” Label May Be Deceptive for Products that Contain GMOs

On May 7, 2020, the First Circuit handed down Lee v. Conagra Brands, Inc., which reinstates a previously-dismissed complaint alleging that Wesson Oil labeled “100% Natural” is plausibly misbranded because it contains corn oil made with GMOs. Until now, GMO class actions have had a mixed reception in the district courts. Lee is the first circuit court decision to ...

FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH

The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance in manufacturing during, or in advance of, a declared public health emergency. On May 6, ...

COVID-19 Issues for Return to the Workplace

As businesses prepare for a return to the workplace (RTW) following COVID-19 closures, our team has created this high-level summary list of current and anticipated issues related to reopening. For additional guidance, please visit our COVID-19 Legal and Business Toolkit or reach out to us at COVID19@cov.com. Links to sections with more information about these ...

New FDA Guidance Describing Exemptions, Exclusions, and Discretion Relating to Drug Supply Chain Security Act Requirements During the COVID-19 Public Health Emergency

The United States Food and Drug Administration (FDA) recently published a Guidance for Industry, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency (Guidance), to (1) clarify the applicability of the Drug Supply Chain Security Act (DSCSA) to certain distribution activities, and (2) ...

COVID-19 Updates of Relevance to the Food Industry

Since Covington’s last client alert on developments for the food industry during the COVID-19 public health crisis, the Occupational Safety and Health Administration (“OSHA”) and the Centers for Disease Control and Prevention (“CDC”) have posted a number of updates of interest to the industry. Additionally, President Trump has issued an Executive Order ...

International Trends in Responses to the COVID-19 Pandemic in the Pharmaceutical Sector

This Alert discusses relevant mechanisms and cross-border trends in responding to the COVID-19 pandemic in the pharmaceutical sector. It focuses on international developments and does not consider the many initiatives and activities that are taking place at the national or local level.

Responding to COVID 19 related business issues in Latin America

COVID-19's march across the globe arrived in Latin America on February 25 in Brazil, coming roughly a month after Europe and the United States. High inequality and variable medical capacity across the region are driving governments to rely heavily on social distancing and business restrictions to slow and prevent the spread of the virus. As a result of this ...

Food and drug regulatory specialists help turn vodka into sanitizer

Wade Ackerman and Scott Danzis spoke with the Daily Journal about their work with clients on emergency use authorization (EUA) requests. Mr. Ackerman says of the firm, “One of the things I appreciate about being in California, but also part of this firm that’s deeply connected with D.C., is that we have connectivity with what’s going on at FDA and on the ...

China and the United States Adjust Export/Import Policies on PPE

This alert provides an update on the regulatory measures regarding medical-use and industrial-use personal protective equipment (PPE) from China to combat COVID-19, including a brief summary of measures the U.S. Food and Drug Administration (U.S. FDA) is taking to facilitate import of PPE from China into the United States. The regulatory guidance from both ...

European Commission proposes postponement of the new EU Medical Device Regulation and broadens Emergency Use Authorization Rules

On April 3, 2020, the European Commission published its proposal for a new Regulation to amend the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year. The proposed new legislation also amends the MDR rules on exceptional special authorizations of non-CE-marked medical devices with immediate effect.

CARES Act Reforms Aim to Prevent Shortages of Critical Medical Products

On March 27, 2020, Congress passed and the President signed into law H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). Recognizing the critical supply chain risks posed by the COVID-19 pandemic, Congress included multiple provisions in the CARES Act that aim to mitigate and prevent future medical product shortages (these ...

COVID-19 Update for Food Companies Navigating Quarantine Disruption - March 30, 2020

On March 28, 2020, the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) updated its March 19, 2020 “Essential Critical Infrastructure Workforce” advisory list. These updates largely focus on clarifying which workers CISA considers to be essential, which may be helpful for the human and animal food industries. At the same ...

FDA Issues Fact Sheet on Safely Distributing Unused Human Food for Animal Food Use During COVID-19

On Friday, March 27, 2020, FDA’s Center for Veterinary Medicine (CVM) issued a Fact Sheet on “Safely Distributing Unused Human Food for Animal Food Use During COVID-19.” The advisory accompanying the Fact Sheet explains that because of COVID-19-associated restrictions on in-store dining, certain businesses may have surplus food that, if not usable for human ...

FDA Releases Guidance on Reporting Potential Disruptions in Supply During COVID-19 Pandemic

On Friday, March 27, 2020, the U.S. Food and Drug Administration (FDA) released updated guidance to ensure that drug manufacturers notify FDA as soon as possible of potential interruptions in manufacturing that could lead to drug shortages. The Guidance, titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of ...

COVID-19: Regulatory Considerations for Medical Device Companies

Medical device manufacturers are facing numerous novel legal, regulatory, and commercial issues as a result of the evolving COVID-19 public health emergency. This slide presentation addresses key regulatory considerations for medical device companies seeking to supply products that are in critical need, including the Emergency Use Authorization pathway and other ...

FDA Grants Nutrition Labeling Flexibility in Response to COVID-19 Pandemic

As numerous restaurants have shut down or limited their service in response to state and local public health orders, many food manufacturers and foodservice distributors have excess inventory on hand that is labeled for use in restaurants, but not for retail sale. Yesterday, in response to industry requests for labeling flexibility in order to shift such ...

Over-the-Counter Monograph Reform in the CARES Act

On March 27, 2020, Congress passed H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Subtitle F of the CARES Act would significantly change FDA’s regulations of over-the-counter (OTC) monograph drugs subject to OTC Drug Review. Congress had introduced earlier versions of the bill, with the latest bill, S. 2740 – Over-the-Counter ...

How should facilities deal with COVID-19?

Miriam Guggenheim is quoted in National Products Insider regarding how food and drug facilities can manage the spread of COVID-19. Ms. Guggenheim says, “The FDA, from the perspective that this is not a food-borne illness and transmittable that way, has said that facilities will not have to shut down. The emphasis is on other employees, not the products you ...

COVID-19 Update for Food Companies Navigating Quarantine Disruption

Over the past several weeks, states and localities across the country have implemented wide-ranging quarantines and curfews meant to slow the spread of COVID-19. Some of these measures have impeded food companies’ efforts to manufacture and distribute critical goods to their intended destinations. Even as the federal government underscores the importance of food ...

FDA Releases Guidance on Postmarketing Adverse Event Reporting During a Pandemic

The U.S. Food and Drug Administration (FDA) released guidance on March 19, 2020 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic” (Guidance). The Guidance revises FDA’s February 2012 final guidance for industry on adverse event reporting during an influenza pandemic to clarify that the guidance ...

Test makers say testing volume ramping up quickly despite concerns over reagents

Scott Danzis spoke with BioWorld about the uptick in coronavirus testing by the FDA and CDC. Mr. Danzis says that while the FDA and the CDC struggled to move testing forward in the early days, “things have shifted dramatically” since that time. He adds that the issue of FDA regulation of lab-developed tests is of long standing, but that the Verifying ...

FDA Addresses Implications of Coronavirus for the Nation's Food Supply

Over the past forty-eight hours, FDA has issued a range of helpful information about the potential implications of COVID-19 for the food supply, including the agency’s current position regarding food safety and COVID-19, guidance concerning supplier verification onsite audit requirements, and an announcement that FDA has suspended routine surveillance facility ...

FDA Releases Guidance on Clinical Trial Conduct During COVID-19 Pandemic

The U.S. Food and Drug Administration (FDA) released guidance on March 18, 2020 entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (Guidance).1 The Guidance comes at a critical time, as clinical trial sponsors, investigators, and Institutional Review Boards (IRBs) grapple with the measures needed to ensure the ...

FDA turns to Twitter to help track testing supply shortages

Scott Danzis is quoted in Politico regarding tracking medical device shortages and whether regulations requiring drug manufacturers to warn the government when a shortage seems likely should be applied to medical devices. Mr. Danzis says, “There's a balance that has to be struck between giving that information to FDA and creating additional reporting ...

FDA Reopens Cannabis Docket

FDA has reopened the comment period indefinitely for its public hearing on products containing cannabis or cannabis-derived compounds.In doing so, FDA is seeking scientific data and information on cannabis and cannabis-derived compounds, particularly cannabidiol (CBD). On May 31, 2019, FDA hosted a public hearing on “Scientific Data and Information About ...

FDA Submits CBD Report to Congress

Yesterday, the Food and Drug Administration (FDA) submitted a report to Congress providing an update on the agency’s evaluation of potential regulatory pathways for CBD products, as well as a description of how FDA expects to proceed moving forward. In its report, FDA summarized the landscape surrounding CBD drugs, dietary supplements, foods, cosmetics, and vape ...

3 Alternative Protein Trends To Watch In 2020

Brian Sylvester noted in Forbes that litigation of alternative proteins was a trend to watch in 2020. Mr. Sylvester says these cases “could influence the ongoing regulatory conversation at the federal level around new standards of identity for both plant-based and cell-cultured meat."

Electronic Health Record Company Settles Department of Justice Kickback Probe

On January 27, Practice Fusion, Inc. (“Practice Fusion”), an electronic health record (“EHR”) company acquired by Allscripts in 2018, agreed to pay $145 million to resolve criminal and civil investigations with the Department of Justice (“DOJ”) related to an illegal kickback arrangement with a major opioid company. Practice Fusion solicited and received nearly ...

FDA Publishes Draft Guidance Proposing to Establish Standardized Assay Limits for Medicated Feeds

Today, the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) published a draft Guidance for Industry (draft guidance) proposing to standardize assay limits for medicated feeds. CVM requests electronic or written comments concerning the draft guidance be submitted to the docket by April 27, 2020. The draft guidance recommends a standardized ...

2019 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2019 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) of the ...

FDA Reopens Comment Period on General Principles for Food Standards Modernization

Today, the Food and Drug Administration (FDA) announced in the Federal Register that it is reopening the comment period for its 2005 proposed rule regarding the modernization of its food standards of identity. FDA’s standards of identity establish detailed requirements regarding the composition and manufacturing of food products. The Agency promulgated most of ...

FDA Publishes Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions and GRAS Notices

On February 13, 2020, the Food and Drug Administration (FDA) issued a draft guidance document describing the pre-submission consultation process for food additive petitions (FAPs) and generally recognized as safe (GRAS) notices for ingredients used in animal feed/pet food, and describing what to include in food use authorization (FUA) requests. The Animal Drug ...

Sarah Cowlishaw Named to The Lawyer “Hot 100”

LONDON—The Lawyer has named London life sciences partner Sarah Cowlishaw to its “Hot 100,” a list that recognizes the most daring, innovative and creative lawyers from in-house, private practice and the Bar around the U.K. The Lawyer highlighted Ms. Cowlishaw’s work for biotech company Sensyne Health on regulatory matters related to its AIM IPO and her ongoing ...

Senate Bill Takes Aim at Cell-Cultured Food Labeling

Brian Sylvester spoke with Food Quality and Safety about a bill aimed at safeguarding accurate and transparent labeling of food products created using animal cell-culture technology. Mr. Sylvester says, “When it comes to food tech, both the FDA and USDA have accommodated new innovations into the existing regulatory framework for years: I think this is absolutely ...

Covington Represents Elanco in Divestitures of Pet Care Products

WASHINGTON—Covington represented Elanco Animal Health in connection with an agreement with Dechra Pharmaceuticals to divest Osurnia® for $135 million in an all-cash deal. Covington also represented Elanco in an agreement to divest the U.S. rights and related assets for Capstar® to PetIQ, Inc., for $95 million in an all-cash deal. Elanco is a global animal ...

CREATES Act Becomes Law

On December 20, 2019, the President signed the Further Consolidated Appropriations Act, 2020. Effective on that day, Section 610 of Division N of this Act contains provisions previously introduced in various bills as “the Creating and Restoring Equal Access to Equivalent Samples Act” or “CREATES Act.”

Regulatory Questions Remain As FDA's CBD Report Deadline Looms

Jessica O'Connell spoke with Inside Health Policy about the FDA's plan to remove adulterated cannabis products from the CBD market. Ms. O'Connell says, "There’s a range of products out there that aren’t compliant, and FDA only has so many resources and can only enforce so much. I think one difference here that might be helpful is that there are these robust ...

Lawyers, Ask These 10 Questions During Digital Health Ideation

Covington has created a list of Top 10 Questions for Ideation of Digital Health Solutions that can help lawyers contribute to the digital health ideation process. Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. "Ideation" is part of that process and involves the rapid ...

HHS and FDA Release Proposed Rule and Draft Guidance on Importation of Drugs Originally Intended for Foreign Markets

On December 18, 2019, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a notice of proposed rulemaking on “Importation of Prescription Drugs” (the “NPRM”) and a Draft Guidance titled “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the ...

Covington Represents Merck In $2.7B Acquisition of Cancer Drug Developer

WASHINGTON—Covington represented Merck & Co., Inc. in its definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7 billion. ArQule is a publicly traded biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of patients with ...

FDA Issues CBD Consumer Update and Warning Letters

Yesterday, the Food and Drug Administration (FDA) published a consumer update on its ongoing analysis of the safety of products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD). FDA also issued warning letters to 15 companies for selling CBD-containing products in violation of the Food, Drug, and Cosmetic Act (FD&C Act). These ...

USDA Issues Hemp Production Interim Final Rule

Today, the U.S. Department of Agriculture (USDA) issued the long-awaited interim final rule (“the rule”) establishing regulations for a domestic hemp production program. The rule provides clarity for hemp growers and related businesses and is a critical next step after the passage of the 2018 Farm Bill last December. Among other things, the rule outlines ...

FDA Grants 6-Month Period of Enforcement Discretion for New Nutrition Labeling Requirements

Yesterday, FDA announced that it will grant a 6-month period of enforcement discretion for manufacturers to meet the agency's new nutrition labeling requirements. In an updated Q&A on FDA's webpage for Industry Resources on Changes to the Nutrition Facts Label, FDA added the following: I understand that FDA has received multiple requests from manufacturers to ...

A New Era of Smarter Food Safety

FDA hosted a public meeting on October 21, 2019 entitled “A New Era of Smarter Food Safety.” The purpose of the meeting was to obtain stakeholder input on the Agency’s food safety initiative launched in April 2019 and inform a strategic blueprint expected to be issued in early 2020.

Flavor Labeling Litigation and What It Means for Your Business

Vanilla-flavored yogurt, ice cream, almond and soy milk have all been caught in the crosshairs recently, targeted by more than a dozen class action lawsuits filed since May 2019 by the same New York-based law firms Sheehan & Associates and Reese LLP.

FDA Releases Two New FSMA-Related Documents

FDA has been active on the FSMA front, and released two new documents over the last few days. Last Friday, October 4, the Agency issued a draft guidance regarding establishing and implementing a recall plan under 21 CFR 117.139, the provision of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PC Human ...

Horizontal Approaches to Food Standards of Identity Modernization

FDA hosted a public meeting on September 27, 2019 entitled “Horizontal Approaches to Food Standards of Identity Modernization.” The purpose of the meeting was to discuss changes FDA could make across food standards to afford manufacturers greater flexibility and to facilitate innovation.

Expanded Conditional Approval Draft Guidance Issued

Yesterday, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) issued a draft guidance explaining the criteria it plans to apply when granting “expanded conditional approval” to new animal drugs not intended for minor uses or minor species that address a serious or life-threatening disease or condition or fill an unmet animal or ...

The Nagoya Protocol at Its 5th Anniversary: Legal Lessons Learned in the Pharmaceutical, Food and Cosmetics Sectors

📄 Download PDF of Client Alert The Nagoya Protocol on Access and Benefit Sharing is the main global mechanism to regulate the access and utilization of biological resources. The agreement entered into force nearly five years ago, on October 12, 2014, as a supplement to the 1992 Convention on Biological Diversity Today, 118 countries are a contracting party ...

FDA Advertising and Promotion Enforcement Activities: Update

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. In July and August, the Office of Prescription Drug Promotion (OPDP) posted enforcement letters on FDA’s website.

China confirms drug reforms to spur innovation, ensure drug quality, ease restrictions

John Balzano is quoted in BioWorld regarding recent updates to China’s drug administration law and the establishment of marketing authorization holders (MAH). Mr. Balzano says, “This creates much-needed flexibility for research-based companies to develop products and bring them to market.” Another advantage of the MAH system is that licenses can officially be ...

China Adopts Revised Drug Administration Law

On August 26, 2019, China’s Standing Committee of National People's Congress (“NPC) adopted a significant revision of the Drug Administration Law (“DAL”). The newly adopted DAL (“Revised DAL”) will go into effect on December 1, 2019. The Revised DAL is the first overhaul of the DAL since 2001.

EPA Seeks Comment on First Set of Hemp Pesticides and Begins to Develop Hemp/CBD Pesticide Policy

The Agricultural Improvement Act of 2018 (the 2018 Farm Bill) has created a rapidly-expanding market for hemp-derived products by legalizing the cultivation of hemp, which can be processed to make a variety of goods, including cannabidiol (“CBD”) products.

Former FDA lawyer: DSHEA largely 'a success'

Peter Hutt spoke with the Natural Products Insider podcast in the second part of a discussion about the FDA’s role over the decades in regulating dietary supplements and efforts to impose restrictions that were stymied time and again. Mr. Hutt says, “FDA has not done adequate enforcement against [companies that put prescription drug ingredients in dietary ...

Asia's Complex Compliance Landscape

Eric Carlson spoke with Pharmaceutical Executive about the compliance challenges prevalent in the Asia-Pacific region. On the emergence of general compliance in the region, Mr. Carlson says, “When I first moved to Beijing in 2008, there were only a couple of dozen people who had compliance on their business card. It just wasn’t a job in China then. Ten years ...

Update: FDA has extended the deadline to July 16, 2019 to submit comments to FDA's public docket on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds

Last Friday (May 31, 2019), FDA hosted a public hearing on “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds.” The hearing followed FDA’s notice in the Federal Register on April 3, 2019, announcing the public hearing and establishing a public docket to obtain information related to cannabis and cannabis-derived ...

Manufacturers push for legal clarity at FDA's first public hearing on CBD

Brian Sylvester spoke with Food Dive about the push from manufacturers for clarity at the FDA’s first public hearing on CBD. Mr. Sylvester says that in the short term, the FDA could issue a policy statement that says if a company is marketing food or dietary supplements with compounds like CBD and it is derived from hemp, which is legal now because of the Farm ...

FDA Focus: What Covington's Practice Chair Is Watching

Denise Esposito spoke with Law360 about hot topics involving over-the-counter medicines, drug prices, and next-generation products that blur the line between biologics and medical devices. She also predicted that new FDA Commissioner Ned Sharpless might revert to allowing directors of the agency's centers.

FDA kicks off review of CBD with 140 people scheduled to testify at first public hearing Friday

Miriam Guggenheim spoke with CNBC about the increasing interest around CBD. Ms. Guggenheim says, “Interest continues to skyrocket. It is mainstream, interest is mainstream. It is not fringe anymore, which doesn’t mean mainstream companies are ready to jump in. But they want to be prepared to do so once the legal landscape is clarified.”

States Could Take Bloom Off Growth Of CBD Supplement, Food Market

Miriam Guggenheim is quoted in HBW Insight regarding Congressional action to exclude hemp from the definition of “marijuana” in the Controlled Substances Act. Ms. Guggenheim says the change does not have a preemptive effect with states and creates confusion, even for some municipal governments. She adds, "The states have their own controlled substances laws and ...

Compliance Corner: When Is An Action Exempt From FDA's Recall Reporting Requirements?

Medtech Insight included Pamela Forrest's comments from FDAnews' 16th Annual Medical Device Quality Congress about medical device recalls from a product enhancement. Ms. Forrest said the key question companies should ask themselves is whether their action makes a safe device better or improves existing safety concerns. If the action improves a device's safety, ...

Former FDA Drug Regulatory Adviser Joins Covington in DC

Julie Dohm was featured in Law360 regarding her move to Covington. Ms. Dohm, who joined Covington in March from the FDA, says, “I was excited about trying to get into private practice. I really want to work with people that are the pillars of food and drug law, and a number of those folks are at Covington.”

Former FDA Official Joins Covington

WASHINGTON—Julie Dohm has joined Covington's Food, Drug, and Device practice in Washington. Dr. Dohm focuses on regulatory matters for pharmaceutical and biotechnology clients. She has handled cases on a wide range of regulatory topics such as preemption, drug promotion, drug shortage, import-export, exclusivity, and generic drug approval standards. Prior to ...

The Brexit Headaches Keeping Partners Awake At Night

Bart Van Vooren is quoted in Legal Week regarding the potential decrease in work for law firms in the UK following Brexit. He says, “A general impression is that small and medium-sized enterprises don’t have enough resources to prepare, while our clients – large worldwide pharmaceutical companies – have invested millions into this. Many have done their homework, ...

Advocates hopeful that Gotlieb's won't derail drive toward new CBD rules

Brian Sylvester spoke with NUTRA Ingredients about the abrupt resignation of the FDA Commissioner and what it could be mean for new CBD rules. Mr. Sylvester says while the FDA may “ultimately choose to undertake rulemaking to authorize the use of CBD in foods and dietary supplements. As an interim action—to facilitate the immediate commercialization of CBD-added ...

China Launches New Product Pathways in Hainan Special Zone

On December 29, 2018, the State Council (China’s chief executive agency) opened a new pathway for drugs to come into China through a special zone in southern China. It suspended certain central regulations in the Bo Ao Lecheng International Medical Tourism Pilot Zone in Hainan Province (“Pilot Zone”) and permitted local authorities to make marketing decisions ...

FDA Issues New Proposed Rule on Regulatory Requirements for Sunscreen Products

Yesterday, FDA issued a much anticipated updated proposed rule on regulatory requirements for over the counter (OTC) sunscreen products. The proposed rule, if finalized, would require significant formulation changes in a number of marketed products that contain sunscreens, including both “beach products” and “cosmetic drugs.”

The 'world is watching' the cell-based meat industry, says Memphis Meats VP: 'Subpar early products can stigmatize an entire category for decades to come

Brian Sylvester is quoted in Food Navigator regarding the potential impact of state-based regulation on the cell-based meat industry. Mr. Sylvester says while there have been a series of bills in individual states attempting to restrict the use of terms such as ‘meat’ or ‘beef’ to the flesh of animals raised and harvested in a traditional manner, these will ...

2018 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2018 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality ...

The New EU Rules on Financial Penalties for Pharma Companies

On January 7, 2019, EU Regulation 2019/5 was published in the Official Journal of the European Union. The Regulation is part of a package that makes numerous significant amendments to the EU’s regime for veterinary medicines and medicated feed, and it also made some key changes to the EU financial penalties regime.

USDA Issues Final Rule on National Bioengineered Food Disclosure Standard

Today, USDA published its long-awaited final rule that establishes the requirements for disclosing bioengineered (BE) foods.1 This alert briefly summarizes the final definition of BE food, the foods that are subject to the BE disclosure, the required BE disclosures, the recordkeeping requirements, and the rule’s implementation and compliance dates.

U.S. Congress Passes the Farm Bill and Removes Restrictions on Hemp

On December 12, 2018, the House passed H.R. 2, the Agricultural Improvement Act of 2018 (“the Farm Bill”). The vote follows the Senate’s passage of the bill on December 11, 2018. If President Trump signs the bill, it would change the regulatory status of hemp and hemp products.

FDA Advertising and Promotion Enforcement Activities Update

This e-alert is part of a series of e-alerts summarizing publicly available U.S. Food and Drug Administration (FDA) enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

FDA Announces Final Guidance on Nutrition and Supplement Facts Labels

Last Friday (November 2, 2018), FDA announced the availability of its final guidance, "Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry." The guidance is in the form of a Q&A that presents FDA's position on the ...

New Laws Expand Requirements for Pharmaceutical Companies to File Agreements With FTC and DOJ

President Trump on October 24 signed the SUPPORT for Patients and Communities Act (H.R. 6), which together with the Patient Right to Know Drug Prices Act (S. 2554), signed October 10, expands the scope of pharmaceutical product-related agreements subject to filing requirements under subtitle B of Title XI of the Medicare Prescription Drug, Improvement, and ...

Consultations on UK Medicines and Medical Devices Regulation in Case of a "No Deal" Brexit

On August 23, 2018, the UK Government published several technical guidance notices relating to the regulation of medicines and medical devices in the event of a “no deal” or “hard” Brexit, i.e., a scenario where the EU and UK fail to conclude a withdrawal agreement and an associated transitional period and where the UK becomes a “third country” from midnight CET ...

FDA Publishes Guidance on “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls”

This morning (September 26, 2018), FDA announced the availability of a draft guidance for industry and FDA staff, “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls,” that explains how and when FDA intends to publicize retail consignees that may have received recalled human or animal foods.

British Irish Chamber calls for State supports to Brexit-proof Ireland’s agri-food sector

Maree Gallagher is quoted in the Irish Examiner regarding Brexit’s impact on Ireland’s agri-food sector. Ms. Gallagher, also Chair of the British Irish Chamber of Commerce Agri-Food Committee, says, “The agri-food sector is Ireland’s largest indigenous industry employing around 250,000 people enabling €12.6bn in exports a year.” Ireland, who is a major source of ...

US FDA's Software Pre-Cert Program: Is The Authority On The Books?

Wade Ackerman is quoted in Medtech Insight regarding the FDA’s software pre-certification program and what that means for device and digital health firms interested in getting new products to the market. Mr. Ackerman says, "The agency has been transparent in that it is considering various legal mechanisms available to the agency to establish the program – ...

ACI Dietary Supplements Regulatory Forum: A 'New' FTC, Changing Supplements Facts panels, and Navigating Retailer Demands

Miriam Guggenheim spoke at the Legal, Regulatory, and Compliance Forum on Dietary Supplements and is quoted in a NutraIngredients article. Guggenheim said that a popular question she gets from industry clients around new dietary ingredients (NDIs) is whether or not an ingredient can be classified as ‘old.’ Despite lobbying from trade associations, Guggenheim ...

FDA Could Stick With Current Advice On NDI Notifications, Old Ingredient Evidence

Miriam Guggenheim spoke at the American Conference Institute and Council for Responsible Nutrition's Legal, Regulatory, and Compliance Forum and is quoted by The Rose Sheet in an article regarding FDA's current draft guidance on new dietary ingredient (NDI) notifications. According to Guggenheim, the agency has little priority, and limited resources available ...

FDA's Intentional Food Adulteration Guide Offers Flexibility, Expert Says Details Needed

Jessica O'Connell is quoted in an Inside Health Policy article regarding FDA's draft guidance aimed at helping the food industry reduce the risk of intentional adulteration. According to O'Connell, industry has had some concerns about how prescriptive the food defense plans would be and how burdensome recordkeeping would be. She adds that many companies already ...

FDA Releases the First of Three Draft Guidances on FSMA’s Food Defense Requirements

Today (June 20, 2018), FDA published in the Federal Register the availability of the first four chapters of a nine-chapter draft guidance (“IA draft guidance”) intended to address the requirements in its final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”).

US, Global Law Firms Look to Ireland for 'Brexit Insurance Policy'

Michael Labson is quoted by The American Lawyer in an article regarding Covington's presence in Ireland. "We were focused on whether it’s a strategic fit with the firm’s overall strengths,” says Labson. “With Brexit, we saw the Irish office would be of growing importance. A lot of large pharmaceutical companies have significant operations in Ireland and large ...

FDA Extends the Compliance Date for Removal of Partially Hydrogenated Oils From Food

FDA announced that it has extended the June 18, 2018 compliance date for removal of industrially-produced partially hydrogenated oils (PHOs) from food. Simultaneously, FDA announced that it had denied approval a 2015 food additive petition (FAP) on limited uses of PHOs.

Three Covington Partners Among Top 100 Women Lawyers in California

LOS ANGELES—Covington partners Carolyn Kubota, Robyn Polashuk, and Sonya Winner have been named to the Daily Journal’s 2018 “Top 100 Women Lawyers” list, recognizing the “top women lawyers in California.” Based in the firm’s Los Angeles office, Ms. Kubota is a member of the American College of Trial Lawyers and has served as lead counsel on high-profile ...

Enforcement of the Nagoya Protocol in the Food, Drugs and Cosmetics sectors - state of play

The Nagoya Protocol to the Convention on Biological Diversity entered into force on 12 October 2014. It imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the cosmetics, food, pharmaceutical and other life science sectors. It now has more than 100 contracting parties, including the European Union.

USDA Issues Proposed Rule on National Bioengineered Food Disclosure Standard; FDA Extends Compliance Date for Nutrition Facts Label Final Rule

USDA and FDA each issued a long-awaited rulemaking document affecting food labeling. FDA issued a final rule extending the compliance date for the Nutrition Facts Label (NFL) Final Rule and the Serving Size Final Rule. For manufacturers with $10 million or more in annual food sales, FDA extended the compliance date for these rules from July 26, 2018 to January ...

BIA Head Attacks Rapporteur Reallocation, But Welcomes Further Clarity On Transition Period

Grant Castle is quoted by The Pink Sheet in an article regarding comments from head of the UK BioIndustry Association stating that authorities are jumping the gun by reallocating all UK centralized rapporteurships to other EU member states before it is clear whether there will be some form of continued regulatory relationship between the UK agency, the MHRA, and ...

CQC report on online primary health services shows progress

Brian Kelly and Raj Gathani are quoted in a Digital Health Legal article regarding a report published by the UK’s Care Quality Commission on "The state of care in independent online primary health services." According to Kelly and Gathani, “The report illustrates some of the teething problems in the inspection system, particularly when applied to online ...

FDA Commissioner Gottlieb Launches FDA’s New Nutrition Strategy

Yesterday (March 29), FDA Commissioner Scott Gottlieb kicked off the agency’s Nutrition Innovation Strategy in his keynote address, “Reducing the Burden of Chronic Disease,” delivered at the National Food Policy forum. The Strategy is intended to promote public health through improved nutrition, encourage industry innovation to create more healthful products, ...

Covington Opens Frankfurt Office

LONDON—Covington will open an office in Frankfurt, Germany on April 3 led by eight partners. Frankfurt will be the firm’s third European office and will work closely with the firm’s five offices in the United States, its three offices in Asia, and its offices in the Middle East and Africa. “Covington will offer German companies a unique capability to help them ...

UK And EMA Could Work Together Informally After Brexit

Bart Van Vooren and Peter Bogaert are quoted by The Pink Sheet in an article regarding the future relationship between the UK and the European Medicines Agency following Brexit. According to Van Vooren, the EU "considers that cherry-picking the benefits of the internal market on a sector-by-sector basis, combined with a request to be able to influence the rules, ...

Oregon HB 4005: New Reporting Requirements for Drug Manufacturers, Health Insurers

On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs.

FDA Issues Guidance on Dietary Fiber and Added Sugars and Announces “Next Steps”

On March 1, FDA issued several guidance documents related to the nutrition facts label (NFL) final rule, including: the long-awaited final guidance on the scientific evaluation of petitions requesting approval of ingredients as dietary fiber; a draft guidance on how to declare added sugars on honey, maple syrup, and certain cranberry products; a final guidance ...

Experts Worry Controlled Substances Bills Could Stifle Research

Thomas Cosgrove spoke at the Energy & Commerce health subcommittee hearing to discuss bills that would amend the CSA with a goal to stem the opioid crisis and is quoted in an FDA Week article. According to Cosgrove, "Virtually all manufacturers of 'solid oral' drugs in the United States use tableting or encapsulating machines in some form," including ...

Federal Judge Enjoins Prop 65 Glyphosate Warning

Yesterday (February 26, 2018), six days after hearing the motion, Judge William B. Shubb of the U.S. District Court granted, in part, a preliminary injunction, enjoining California’s Proposition 65 warning requirement for glyphosate. The court concluded that the Plaintiffs had demonstrated a likelihood of success on the merits that the State’s glyphosate warning ...

Wade Ackerman and Aaron Lewis Named Among LA's Most Influential Diverse Lawyers

LOS ANGELES—The Los Angeles Business Journal recognized Wade Ackerman and Aaron Lewis in its second annual list of the most influential diverse lawyers in Los Angeles. The list recognizes 50 "stellar diverse lawyers in the LA region." In Mr. Ackerman’s profile, the Business Journal emphasized his work in the FDA regulatory space. The profile noted that “with a ...

Lawyers Expect FDA To Continue Regulating Cosmetics With Warning Letters In 2018

Inside Health Policy highlights a Covington alert in an article regarding FDA's approach to the regulation of cosmetics. "As we begin 2018, the cosmetic industry marketing products in the United States faces a range of legal and regulatory considerations -- from labeling and marketing claims to ingredient safety and environmental issues," the alert says.

Increasing Pressure on Orphan Medicinal Product Designations in the EU

In the EU, a sponsor can obtain an “orphan designation” for a medicinal product pursuant to Regulation 141/2000. Adopted in December 1999, the regime aims to encourage investment in R&D for treatments for rare diseases. The most important incentive is the 10-year market exclusivity for designated products. Other incentives include protocol assistance and fee ...

FDA Releases FSVP and Supply Chain Program Draft Guidances and Announces FSVP Enforcement Discretion

Last week (January 24, 2018), FDA issued a series of guidance documents and an enforcement discretion policy intended to help the food industry comply with the requirements of the Food Safety Modernization Act (FSMA). The documents further FDA’s goal to ensure that all food under its jurisdiction is produced under procedures that comply with its risk-based food ...

2017 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2017 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation and Research ...

Cosmetic Regulatory Update: Key U.S. Issues for 2018

As we begin 2018, the cosmetic industry marketing products in the United States faces a range of legal and regulatory considerations – from labeling and marketing claims to ingredient safety and environmental issues. This alert for our cosmetic clients analyzes federal regulatory activities in 2017 and summarizes key issues to consider for 2018, including ...

DoH expands CQC healthcare quality rating powers

Raj Gathani is quoted in a Digital Health Legal article regarding the UK Department of Health's decision to expand the Care Quality Commission's (CQC) quality rating powers. “In a sense, the announcement simply corrects an imbalance between NHS and private providers,” says Gathani. “The announcement comes after a year in which online doctor services have come ...

FDA Announces Broad Plan to Improve and Expedite Dissemination of Recall Information to Consumers

FDA announced the availability of a new draft guidance in last Friday’s Federal Register that Commissioner Gottlieb explains describes FDA’s policy on public warning and recall notifications, which “gives industry clear direction on how to navigate and work with the FDA to make sure recalls are communicated promptly,” and “will empower consumers by providing ...

FDA Announces “Nutrition Action Plan” while Stakeholders await Final Guidance on Nutrition Labeling

As we near the two year mark since FDA issued the new Nutrition Facts Label (NFL), stakeholders anxiously await FDA’s final NFL guidance, particularly FDA’s conclusions on the pending fiber petitions and other fiber ingredients. Although FDA proposed last fall to extend the July 26, 2018 compliance date until January 1, 2020 (for large companies and January 1, ...

FSIS Releases Proposed Egg Products HACCP Rule

On Tuesday, January 9, 2018, USDA’s Food Safety and Inspection Service (FSIS) released a proposed rule that would require egg products plants to develop and implement hazard analysis and critical control point (HACCP) plans, Sanitation Standard Operating Procedures (SOPs), and include safe-handling instructions on the labels of certain egg products.

FDA Outlines Updated Approach to Regulating Digital Health Technologies

On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...

FDA's First 90-Day Letters To Deliver Inspection Outcomes After Jan. 1

Tom Cosgrove spoke at the Food and Drug Law Institute's enforcement conference and is quoted by The Pink Sheet in an article regarding FDA's anticipated release of the first 90-day letters. According to Cosgrove, "You will be getting these classifications in 90 days and final means final. What does that mean for people working on these classifications? That ...

The Brexit battle over food

Brian Kelly spoke at November's Food Matters Live event in London and is quoted in a Better Wholesaling article examining challenges facing the food industry in the wake of Brexit. Commenting on the threat of new tariffs, Kelly said, "It is very complicated and businesses will need to upskill on this.”

Covington Lures Back FDA Drug Quality Leader

Tom Cosgrove is quoted in a Law360 article regarding his return to Covington's Food, Drug and Device Practice Group. “I think companies are looking hard at their supply chain risks and wondering how much they can trust other companies that make up the links in that chain,” Cosgrove says. “These challenges, brought about by increased globalization, will only ...

Former FDA Official Rejoins Covington's Life Sciences Practice

WASHINGTON—Tom Cosgrove, who until last month was a senior official at FDA charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients, has rejoined Covington as a partner in its Food, Drug, and Device practice, resident in Washington. Mr. Cosgrove held senior leadership positions within FDA’s Office of Compliance in the Center ...

FDA Releases Comprehensive Regulatory Framework for Regenerative Medicine

In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...

FDA Issues Draft Guidance On Best Practices for Convening a GRAS Panel

Earlier this week, FDA issued a long-anticipated draft guidance on best practices to follow when convening an expert panel to evaluate whether a substance is “generally recognized as safe,” or GRAS, under the conditions of its intended use in food.

Miranda Cole Named Among Politico's "Women Who Shape Brussels"

BRUSSELS—Politico has named Covington partner Miranda Cole to its “2017 Women Who Shape Brussels” list, a group of “20 powerhouses driving debates and influencing policy in 2017.” In its profile of Ms. Cole, the publication highlights her defense of leading technology clients, including Microsoft, Facebook, and Verizon, before the European Commission. Politico ...

FDA Reauthorization Act of 2017: Select Drug Provisions

On August 18, 2017, President Donald Trump signed into law the FDA Reauthorization Act of 2017 (FDARA). This law, containing nine titles, reauthorizes and amends the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.

China moves to accept overseas data, approval times could speed up

John Balzano is quoted in a BioWorld MedTech article regarding the decision by Chinese regulators to accept data from clinical trials conducted outside China for approvals of new drugs and medical devices. “In general, this statement is part of a long-term effort by the government and the China Food and Drug Administration that has been ongoing since 2015 to ...

Top 10 Game-Changing Litigator Moves in October

The Litigation Daily recognizes Jennifer Saulino's move to Covington as one of the top "Game-Changing Litigator Moves in October." According to John Hall, “Jennifer’s skill and experience in litigating and trying fact-intensive cases combined with her track record of success in complex jury cases will benefit our clients and strengthen the firm’s general ...

European approvals face delay from agency move

Grant Castle is quoted in an EP Vantage article examining how the move of the European Medicines Agency from London will impact European drug approvals. According to Castle, the main consequence of lower staff numbers could be longer waiting times to file drugs. “Because of the regulatory timetable there isn’t a huge amount of scope for delaying reviews, but ...

Insurance Coverage for Lost Income Due to Supply or Manufacturing Problems in Puerto Rico

Last month, Hurricanes Irma and Maria battered Puerto Rico, which is a major center of pharmaceutical manufacturing. Damage there to property, roads, bridges, communications, power, and water systems may take months or more to repair. Some, including the FDA, have expressed concern that the damage could lead to shortages of important drugs, medical devices, and ...

Andriukaitis: Supporting drug innovation is 'the only way'

Peter Bogaert is quoted in a EurActiv article regarding EU Commissioner for Health and Food Safety Vytenis Andruikaitis' remarks in support of drug innovation. "The incentives which are built in the pharmaceutical regime and especially the SPCs and the regulatory exclusivity aim to work as a stimulus to develop new products in order to basically continue the ...

State Appellate Vets Team Up; Another Law Firm Merger; Inside Clyde's Insurance Practice Play

The National Law Journal highlights Jennifer Saulino's return to Covington. “Covington offered me a really exciting opportunity to marry my focus on trial work with Covington’s diverse practice areas and client base on a very large scale," she says.

Leading Trial Lawyer and Former DOJ Prosecutor Rejoins Covington

WASHINGTON—Jennifer Saulino has joined Covington’s Litigation and White Collar Defense and Investigation practices as a partner in Washington. Ms. Saulino’s practice focuses on trials as well as defending individuals and corporations in investigations and prosecutions, with particular experience in the pharmaceutical, health care, banking and securities, oil and ...

Former DOJ Prosecutor Rejoins Covington In Washington

John Hall and Jennifer Saulino are quoted in a Law360 article regarding her return to Covington as a partner in the firm's Litigation and Investigations practice. According to Hall, Saulino has “earned the respect and admiration of her colleagues and adversaries” in the courtroom with both her skills and her willingness to take on the most difficult cases. ...

Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses

Scott Danzis is quoted in a Regulatory Focus article regarding the allowance of third-party reviews under the FDA Reauthorization Act. “While the revised statute does allow for implantable, life sustaining, or life supporting devices to be eligible for third party review, we expect that FDA will be cautious in adding such devices to that program," Danzis says. ...

FDA Reauthorization Act of 2017: Key Provisions Related to Medical Devices

On August 18, 2017, President Trump signed H.R. 2430, the FDA Reauthorization Act of 2017, which became Public Law No. 115-52 (“FDARA”). Principally, FDARA reauthorizes the Food and Drug Administration (“FDA” or “the agency”) user fee programs, including the Medical Device User Fee Amendments, the Prescription Drug User Fee Amendments, the Biosimilars User Fee ...

Covington Represents IFM Therapeutics in $300 Million Sale of Assets to BMS

NEW YORK—Covington is representing IFM Therapeutics in its sale to Bristol Myers Squibb for $300 million in cash and the right to receive contingent payments upon achievement of specified milestones that could total in excess of $1 billion for each of its two oncology programs. Prior to closing, IFM will spin off its inflammation program to a newly-formed ...

Repeal Debate Clouds Next Important Health Bill

Denise Esposito is quoted in a CQ Quarterly article regarding the possible reduction in FDA staff if the bill to renew funding is not authorized by Congress. According to Esposito, "Not only does it create regulatory uncertainty and affect employee morale, but, in advance of a possible lapse in appropriations, FDA is required to divert valuable resources from ...

What Brexit means for drug regulation

Grant Castle is quoted in a Pharmafile article regarding how Brexit may affect drug regulation. “Even if we enter into a close free-trade agreement, the UK will lose influence in the development of pharmaceutical legislation and policy, and will also lose influence in the pharmaceutical regulatory procedures,” says Castle. “And that must inevitably mean that ...

China Ready For More Medtech Market Access Simplifications

Medtech Insight references an Inside Medical Devices blog post in an article regarding the impact of China's draft circulars on medical device manufacturers. According to Covington's post, the four proposals represent important reforms to the existing drug and medical device regulatory regimes, and are intended to reduce obstacles that have delayed the launch of ...

Covington's LA Office Makes Another Lateral Addition

Carolyn Kubota and John Hall are quoted by The Recorder in an article regarding Kubota's recent arrival to Covington's Litigation and White Collar Defense and Investigations practices in Los Angeles. “I hope I’ll be able to expand the work I’m doing for pharma companies to other companies and broaden, rather than change, [my practice],” Kubota says. According to ...

Covington Hires Kubota from O'Melveny After 17-Year Long Stay

John Hall and Carolyn Kubota are quoted in a Daily Journal article regarding Kubota's recent arrival to Covington's Los Angeles office. According to Hall, "Carolyn is a world-class litigator with an exceptional track record of trial success, and her tenacity and depth of experience will be highly valuable to our clients," adding that her track record of handling ...

Covington Snags Undefeated Litigator From O'Melveny

Carolyn Kubota and John Hall are quoted in a Law360 article regarding Kubota's arrival to Covington's Los Angeles office as a partner in the firm's Litigation and White Collar Defense and Investigations practices. “A friend of mine once said, [trials] are the most fun you can have wearing a suit, and I’m a strong believer in that,” Kubota says. “I find [that], ...

USDA Releases Questions for Input on the National Bioengineered Disclosure Standard Proposed Rule

Today, USDA’s Agricultural Marketing Service (AMS) released 30 questions to gather input from stakeholders that it will use in drafting a proposed rule as required by The National Bioengineered Food Disclosure Standard enacted last year on July 29, 2016 (click here for Covington’s client alert). By statute, AMS has two years--until July 29, 2018--to establish a ...

U.S. FDA's New Game Plan For Digital Health

Wade Ackerman is quoted in a Medtech Insight article regarding FDA's regulatory strategy in relation to digital health. "While Congress addressed some aspects of FDA's regulation of health software in the 21st Century Cures Act last year, the digital landscape continues to evolve rapidly," Ackerman says. "FDA's intent to outline a new digital health innovation ...

FDA Advertising and Promotion Enforcement Activities: Update

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. In May, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following letter on FDA’s website: Untitled ...

Comment: Licensing drugs post-Brexit amounts to surmountable administrative task

Robin Blaney is quoted in an MLex article regarding pleas from the EMA urging UK drugmakers to relicense their products in another EU country before Brexit. According to Blaney, the transfer of authorizations is "primarily an administrative exercise," and there is no legal obstacle to using a shell company in the European Economic Area to hold marketing ...

CFDA Releases Groundbreaking Drug and Device Policies for Public Comment

On May 11 and 12, 2017, the China Food and Drug Administration (“CFDA”) published drafts of four proposed policies in the form of circulars (or notices) for public comment. These “Proposed Policies” include significant reforms in the areas of the new drug and device approval process (“Circular 52”), clinical trial regulation (“Circular 53”), life-cycle ...

The Brexit Club featuring Barclays, Cambria Automobiles and Gear4music

Bart Van Vooren is quoted in PaRR's "Brexit Club" column regarding the two-part approach to the Brexit negotiation process, following the publication of draft negotiating directives for “phase one” of the talks. According to Van Vooren, there are real legal problems with this two-part approach, regardless of the parties' up-front negotiating positions. One ...

FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More

Wade Ackerman is quoted by MedTech Insight in an article covering the May 5 Food, Drug and Law Institute's annual meeting in Washington. Ackerman provided his insights on the hiring trajectory for those individuals tasked to implement the 21st Century Cures Act, and noted that the funds can be viewed as having broad applications for hiring. Ackerman stated, ...

CFDA Seeks to Remove Some Barriers to Foreign Drug Entry into China

On March 17, 2017, the China Food and Drug Administration (“CFDA”) released a notice to seek public comments on four proposed adjustments to China’s drug registration requirements (“Proposed Adjustments”) that will remove some barriers to applications for clinical trials and drug registrations of imported drugs (drugs that are manufactured outside of China). The ...

President Issues New Executive Order, Requires Agencies to Establish Regulatory Reform Task Forces

On February 24, 2017, President Donald Trump signed an executive order entitled “Enforcing the Regulatory Reform Agenda” (the “Executive Order” or the “Order”). The Order is one of several actions the Trump Administration has taken concerning regulatory reform since inauguration.

China to slash drug distribution groups in price drive

Eric Carlson is quoted in a Financial Times article regarding an initiative by the Chinese Government to reduce marked-up prices and corruption in multi-tier distribution chains of pharmaceuticals, known as the “two invoice reform.” According to Carlson, the crackdown on small distributors would accelerate sector consolidation, “centralising distribution in a ...

Life Sciences Group Of The Year: Covington & Burling

Law360 selected Covington’s Life Sciences practice as a “Practice Group of the Year,” highlighting the firm’s involvement in billion-dollar transactions, success in contentious litigation, and regulatory advice on cutting-edge technology. According to Michael Labson, “What we offer and bring to complicated, complex issues is a mixture of deep subject-matter ...

Covington Represents India-Based Healthcare Company In Drug Portfolio Acquisition

WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in its agreement to acquire a portfolio of intrathecal spasticity and pain management drugs from Mallinckrodt LLC. The purchase price was $171 million, plus an earn-out of up to an additional $32 million. This is the third acquisition that ...

The “Regulatory Freeze”: What it Means for Key Food Regulatory Initiatives

On Friday, President Trump (through his Chief of Staff) issued a memorandum directing all federal agencies to place a freeze on new or pending federal regulations so that the Trump Administration can review them. This alert explains the scope of this action and analyzes its potential impact on key food regulatory initiatives.

Chinese Government Issues Policy to Slim Distribution Chain of Pharmaceuticals

On January 9, 2017, eight Chinese ministries announced a significant new policy that aims to reduce marked-up prices and corruption in multi-tier distribution chains. The policy effectively requires that under most circumstances, at most two invoices may be issued throughout the distribution chain, with one from the manufacturer to a distributor and another from ...

Industry Communications With Payors: US FDA Okays Info On Investigational Drugs

Michael Labson is quoted by The Pink Sheet in an article regarding FDA’s draft guidance on payor communications. According to Labson, the draft guidance is consistent with changes from the 21st Century Cures Act and evolving case law on the First Amendment, and "provides additional important flexibility for manufacturers to communicate science-based information ...

FDA Issues Discussion Paper on Possible Regulatory Approach for Laboratory Developed Tests

On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible ...

Stay Of Execution In EU For Environmental Shortfall Devices

Cándido García Molyneux is quoted in a Medtech Insight article regarding an expected amendment to the Directive on the Restriction of Hazardous Substances (RoHS2). According to García Molyneux, if proposed, non-RoHS compliance electronic medical devices, IVDs and control instruments may be further supplied in the distribution chain or resold after July 22, 2019 ...

EC Plans to Lift Resale, Marketing Deadline for Non-Compliant Devices

Cándido García Molyneux is quoted in an International Devices & Diagnostics Monitor article regarding the European Commission’s plan to allow certain second-hand and refurbished devices that contain hazardous substances to continue to be marketed in the EU beyond July 22, 2019. According to García Molyneux, the ban would greatly restrict the availability of ...

IBM Digs Deeper Roots In Medtech, As AdvaMed Builds Digital Footprint

Wade Ackerman participated at the Medtech Showcase and is quoted in a Medtech Insight article regarding the launch of AdvaMed Digital and the increased focus on medtech and digital health. According to Ackerman, having the dedicated sector within AdvaMed will be a positive for future digital-health policy development.

Pandemic Vaccines Probably Can't Use Accelerated Approval - US FDA Chief Scientist

Denise Esposito is quoted by The Pink Sheet in an article regarding the difficulty of accelerating pandemic vaccine development. According to Esposito, further complicating the development is the frequent lack of a good human model, as it is typically unethical to expose humans to a disease to test the vaccine's efficacy. She adds that this issue has been a far ...

J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva's Slowed Growth, Merck's Keytruda Wins, Lilly's CDK4/6 Hopes And More

Wade Ackerman participated at the Biotech Showcase and is quoted by The Pink Sheet in an article regarding the increased use of real-world evidence by FDA following the passage of the 21st Century Cures Act. According to Ackerman, FDA will be running a pilot program to evaluate the potential of real-world evidence to support supplemental indications and satisfy ...

2016 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This alert reviews trends emerging from the warning and untitled letters issued in 2016 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER). No warning or untitled letters concerning promotion were issued this year by the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation ...

FDA Issues Draft Guidances on Nutrition Labeling

Yesterday, FDA issued a long-anticipated draft guidance intended to help industry comply with the agency’s May 2016 final rules modernizing nutrition labeling. Presented in a question-and-answer format, the draft guidance (Q&A Draft Guidance) provides information related to the compliance date, labeling of added sugars, rounding of the declaration of ...

Six Covington Lawyers Named Law360 MVPs

WASHINGTON—Law360 has named six Covington lawyers as MVPs in their respective practice areas. The awards single out lawyers from across various practice areas based on their “success in high-stakes litigation, complex global matters, and record-breaking deals.” The Covington lawyers recognized as Law360 MVPs are: Shara Aranoff, International Trade. Ms. ...

21st Century Cures Act: Key Provisions (Title III - Development)

On December 13, 2016, President Obama signed H.R. 34, the 21st Century Cures Act, which became Public Law No. 114-255 (“the Act”). Its enactment represents the culmination of a multi-year bipartisan legislative process spearheaded on the House side by Energy and Commerce Committee Chairman Fred Upton, Ranking Member Frank Pallone, and Rep. Diana DeGette and on ...

Food & Beverage MVP: Covington's Jessica O'Connell

Law360 selected Jessica O’Connell as a 2016 Food & Beverage MVP and profiled her involvement in FDA’s decision to review its “healthy” labeling regulations after convincing the agency to refrain from taking legal action against Kind LLC over allegedly misleading labeling of snack bars. According to O’Connell, her intimate understanding of the FDA was helpful as ...

Global Enforcement of the Nagoya Protocol in Life Sciences Industries

In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to ...

Medical Device Reporting for Manufacturers; Final Guidance

On November 8, 2016, the U.S. Food and Drug Administration (FDA) published a final guidance titled Medical Device Reporting for Manufacturers (“Final Guidance”). The guidance explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. On November 30, ...

Positions Staked out on Impact of First Amendment on Manufacturer Communication on Off-label Uses

Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Health Law News and Commentary article regarding constitutional concerns surrounding manufacturer communication of information on off-label uses. According to Labson, the FDA should proceed in "a step-wise fashion that balances ...

FDA Questions Need for Looser Off-Label Promotion Restrictions

Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Regulatory Affairs Professionals Society article regarding regulations on off-label promotions for drugs and devices. According to Labson, safe harbors are needed for communicating certain types of information outside a drug's ...

FDA Releases Final Guidance for Industry on Voluntary Qualified Importer Program for Food

On November 10, 2016, the Food and Drug Administration (FDA) released its final guidance for industry on the voluntary qualified importer program (VQIP). The final guidance builds upon draft guidance issued in June 2015, as part of FDA’s implementation of the FDA Food Safety Modernization Act of 2011 (FSMA) mandate to establish a voluntary, fee-based program to ...

Industry, Patient Advocates at Odds as FDA Revisits Off-Label Communication

Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America where he laid out a stepwise approach PhRMA believes FDA should take regarding off-label communication, and is quoted in an FDA Week article. According to Labson, FDA should create three safe harbors for different types of communication: first, ...

FDA Asks Industry Where to Draw the Line on Off-Label Communication

Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Drug Industry Daily article providing key points from the meeting on off-label communication. According to Labson, communication should be rooted in scientifically-sound findings.

PhRMA To FDA: Weigh Payer Communication Before 1st Amendment Issue

Michael Labson spoke at the FDLI Annual Advertising Conference and is quoted in an FDA Week article regarding communication between drug makers and payers under a section of the FDA Modernization Act. According to Labson, first amendment jurisprudence may make concerns over FDAMA 114 a non-issue. "If the first amendment idea that you have a constitutional right ...

Brexit ruling “only adds to uncertainty” in the UK food industry

Brian Kelly is quoted in an EU Food Law article regarding the UK High Court ruling requiring its government to have Parliamentary approval before triggering Article 50. According to Kelly, the decision added uncertainty around Brexit, although it did also present a lobbying opportunity for the industry as well. “The immediate impact of the judgment is that, as ...

China Proposes Expanded Criteria, Increased Penalties for Device Recalls

John Balzano participated in an FDAnews webinar and is quoted in an article regarding China FDA’s proposed expanded requirements for medical device recalls and higher fines for manufacturers that fail to issue recalls. According to Balzano, to be eligible for the accelerated pathway for breakthrough medical devices, the intellectual property for the device needs ...

Spanner In Works For UK Gov’t’s Brexit Plans; Industry Looks To Ongoing Talks With Ministers

Brian Kelly is quoted by The Pink Sheet in an article regarding the UK High Court’s ruling that its government does not have the right to trigger Article 50 without Parliamentary approval. According to Kelly, the judgment presented "an opportunity for individual companies and the [life sciences] industry to engage with members of Parliament to ensure that their ...

FDA Releases Draft Guidance on “Disclosure Statement” Provisions of Four FSMA Rules

Last week, FDA released a draft guidance1 clarifying requirements for the “disclosure statement” provisions of its four major Food Safety Modernization Act (FSMA) rules. Entities subject to these provisions must disclose, in documents accompanying the food, that certain hazards have not been controlled. The draft guidance provides insight into the circumstances ...

Combo Product Reforms May Appear in User Fees if Not Passed in Lame Duck

Wade Ackerman spoke at a DIA conference on October 24 and is quoted in an FDA Week article regarding combination product reform. According to Mr. Ackerman, there has been strong bipartisan support for 21st Century Cures and Medical Innovation bills. However, if combination product language does not get passed in this Congress, Ackerman also pointed to the FDA ...

Covington Represents India-Based Healthcare Company in Acquisition

WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in the acquisition of five anesthesia and pain management injectable products from Janssen Pharmaceutica NV, in an all cash deal for an upfront consideration of US$155 million, and up to an additional US$20 million. The products to be acquired ...

Clinical Trials Registration and Results Information Submission; Final Rule

On September 21, 2016, the National Institutes of Health (NIH) published its final rule, Clinical Trials Registration and Results Information Submission, 42 C.F.R. Part 11. Under Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA), “responsible parties” for specified clinical trials of FDA-regulated drug and device products must submit ...

Vantage point – What Brexit means for life science funding and strategy

Grant Castle is quoted in an EP Vantage article regarding the effect of Brexit on life science funding and strategy. According to Castle, “Particularly if the UK heads for a ‘hard Brexit,’ the UK will be a less attractive venue for investment by pharma. It’s one of the sad side effects of all this.”

China's Proposed Rules Expand Penalties for Medical Device Recalls

John Balzano participated in an FDAnews webinar and is quoted in an Inspection Insider article regarding China FDA’s proposed rules that increase penalties for devicemakers that fail to issue recalls. Commenting on the agency’s “accelerated pathway” for breakthrough medical devices, Balzano says that in order to be eligible for the pathway, the devices’ ...

FDA Issues Enforcement Discretion Guidance and Requests Public Comments on Use of “Healthy” in Food Labeling

Today, the Food and Drug Administration (FDA) issued a guidance document communicating its intent to exercise enforcement discretion regarding certain uses of “healthy” in food labeling for products that do not meet FDA’s current “healthy” regulatory requirements but that contain predominantly “good fats” or are a good source of certain nutrients (“healthy” ...

Prominent Medical Device Lawyer Joins Covington

WASHINGTON—Pamela Forrest has joined Covington in its Food, Drug, and Device practice, resident in Washington. Ms. Forrest has more than 20 years of experience advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket review, product recalls, medical device reporting (MDR), Quality System ...

Highest EU Court Rules on Ban to Market Cosmetics Tested on Animals

On September 21, 2016, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-592/14 European Federation for Cosmetic Ingredients v UK Secretary of State for Business. The Court has ruled that animal tests performed outside the European Union (EU) to comply with non-EU rules should not be used for the product safety assessment to gain access to ...

Food attorneys consider ‘healthy’ claims

Jessica O’Connell participated in the Food and Drug Law Institute’s Food Advertising, Labeling, and Litigation Conference and is quoted in a Food Chemical News article regarding “healthy” claims. According to O’Connell, FDA considers “healthy” not to be an implied nutrient content claim when it refers to general dietary guidance.

FDA Holds Public Hearing and Seeks Comment on Draft Guidances Concerning Regulation of HCT/Ps

On September 12 and 13, 2016, the U.S. Food and Drug Administration (FDA) held a two-day public hearing to obtain input on four draft guidance documents issued by the agency concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps).

China's Changing Device Regulations: What You Need to Know

John Balzano participated in an FDAnews webinar and is quoted in an International Devices & Diagnostics Monitor article regarding China’s changing device regulations. According to Balzano, "Overall, they're going to want to make sure that they have a regulatory structure in place that facilitates the most innovative applications and the applications for devices ...

Health Hires: Government Attorneys Join Covington, Foley

Wade Ackerman and Denise Esposito are quoted in a Law360 article regarding Ackerman’s recent arrival as a partner in the firm’s Food, Drug, and Device practice. According to Ackerman, he’d like to serve as bridge between Washington, D.C., and Los Angeles for the firm. For a food and drug attorney, Covington is the place to go, given its “long history of having a ...

FDA Publishes Final Rule for Consumer Antiseptic Washes

Yesterday, FDA published its final rule regulating certain active ingredients found in over-the-counter (“OTC”) consumer antiseptic wash products that are intended to be used with water and rinsed off after use, such as hand or body washes, which FDA refers to as “consumer antiseptic washes” (the “Final Rule”). In the Final Rule, FDA deems 19 active ingredients ...

Covington Expands LA Office as 'Silicon Beach' Takes Shape

Wade Ackerman and Robyn Polashuk are quoted in a Recorder article regarding the growth of the firm’s LA office, which includes Ackerman’s recent arrival. "We're in a period of unprecedented change in the way products are regulated, and a lot of companies are on the West Coast,” said Ackerman. Commenting on West Coast business, Polashuk says, “It hasn't been, ...

Leading FDA Lawyer Joins Covington's Life Sciences Practice

LOS ANGELES—Wade Ackerman has joined Covington as a partner in its Food, Drug, and Device practice, resident in Los Angeles. Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health, Education, Labor & Pensions Committee. In this role, he has been intimately involved in legislative initiatives, oversight hearings, and other Senate ...

4 Ways Brexit Could Affect the Supplement Industry

Brian Kelly is quoted in a Nutritional Outlook article regarding the ways Brexit could affect the supplement industry. According to Kelly, “If the UK went down a Norway or EEA model approach, it’s very unlikely that there’d be any material change to the legal position.” He continues, “The UK’s implementation of EU existing food law would remain valid and the UK ...

FDA Releases Draft Guidance on Human Food By-Products For Use As Animal Food

Earlier this week, the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) published Draft Guidance for Industry No. 239, “Human Food By-Products for Use as Animal Food” as part of the agency’s implementation of the Food Safety Modernization Act (FSMA). The draft guidance describes the regulatory requirements — including the ...

FDA Releases Draft Guidance Regarding Current Good Manufacturing Practice Requirements for Animal Food

Earlier this week, the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) published Draft Guidance for Industry #235, “Current Good Manufacturing Practice Requirements for Food for Animals,” as part of the agency’s implementation of the Food Safety Modernization Act (FSMA). The draft guidance contains information designed to help ...

FDA Releases Long-Awaited Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food

Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act ...

FDA Issues a Final Rule on Substances Generally Recognized as Safe (GRAS) for Their Intended Use in Animal Food

Nineteen years after first publishing its proposal, FDA published in yesterday’s Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in human and animal food. This Alert addresses the final rule as it applies to food for animals. For an analysis of how the final rule will affect human food, see our Alert “FDA ...

FDA Issues a Final Rule on Substances Generally Recognized as Safe (GRAS) for Their Intended Use in Food

This morning, August 17, 2016, FDA published in the Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in food. Coming nineteen years after the proposed rule, under which industry has effectively been operating for some time, the final rule mostly codifies the status quo. The final rule formalizes, through ...

FDA Issues a Revised Draft Guidance on New Dietary Ingredients Used in Dietary Supplements

On August 11, 2016, FDA published its long-awaited revised draft guidance on Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Like the 2011 draft it replaces, the revised draft guidance is intended to help a dietary supplement company decide (1) whether a substance is a dietary ingredient; (2) when a new dietary ingredient (NDI) ...

European Regulators: Brexit's Effect On FDA Inspection Pact With EU Unclear

Grant Castle is quoted in an FDA Week article regarding the likelihood that the UK will remain part of the Mutual Reliance Initiative between the U.S. and EU. "If the UK does Brexit, but executes the European Economic Area (EEA) Agreement, as Norway, Iceland and Liechtenstein have done, it would continue to implement all new EU pharmaceutical rules and ...

The medical foods category has an uncertain bill of health

Jessica O’Connell spoke at the IFT expo and is quoted in a Food Dive article regarding medical food products. O’Connell, commenting on how companies have tried to develop medical food, said the most common warning letters sent out by the FDA since 2006 use the words no “distinctive nutritional requirement” for the disease or condition. She added that since 2009, ...

FDA Issues Final Rule for Registration of Food Facilities

On July 14, 2016, FDA published its amended final regulations for registration of domestic and foreign food facilities under the Food Safety Modernization Act (FSMA). Registration is required for such facilities that manufacture/process, pack, or hold food for human or animal consumption. The final rule codifies a number of provisions that were mandated by FSMA ...

Both Houses of Congress Pass S.764 Establishing the National Bioengineering Food Disclosure Standard, Which Would Immediately Preempt Key Parts of the Vermont GMO Labeling Law

Yesterday, the United States House of Representatives passed Bill S.764 (“Joint Bill”), which will amend the Agricultural Marketing Act of 1946 to add Subtitle E: “National Bioengineered Food Disclosure Standard,” and Subtitle F: “Labeling of Certain Food.” The United States Senate passed the same bill last week on July 7, 2016. The Joint Bill, if signed into ...

House Clears GMO Labeling Bill as Eyes Turn to Rulemaking

Miriam Guggenheim is quoted in a BNA article regarding legislation passed by Congress creating a national standard for food makers to disclose genetically-modified ingredients. According to Guggenheim, while there is considerable will in the administration to resolve the GMO labeling issue, agency resources would also play a role in the rulemaking timeline. ...

Impact of Brexit on EU Medical Devices Regulation and Structures

The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear ...

Impact of Brexit on Food and Drink Regulations

Last week, the UK voted to leave the European Union in an advisory referendum. The impact of Brexit on food and drink regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear ...

Drugmakers Ensnared in Brexit Seek Sway Over Medicine Cabinets

Grant Castle is quoted in a Bloomberg article regarding the implications of Brexit on the future of the pharmaceutical industry and the drug approval process. According to Castle, the best that the UK regulator could hope for would be an observer status on European Medicines Agency committees. That loss of influence could make the UK less appealing, because it ...

Brexit Leaves U.S. Regulatory Attorneys With Many Questions

Grant Castle is quoted in a Legal Intelligencer article regarding the regulatory impact of Brexit. Commenting on the Food and Drug sector, Castle says, “The UK will inevitably diminish in significance when it comes to the regulation of pharmaceuticals and a venue where drug companies are going to want to be based. Historically, U.S. companies wanted to operate ...

Impact of Brexit on Pharmaceutical Regulations and Structures

Last week, the UK voted in an advisory referendum to leave the European Union. The next steps are not yet clear, but the referendum may have significant implications for the pharmaceutical industry in the UK and for international companies operating in the UK. Its impact will very much depend on the form a post-Brexit UK will take, the relationship that the UK ...

‘Painful…power vacuum’ coming for European Medicines Agency

Grant Castle is quoted in a Politico article regarding the effect of Brexit on the future location of the European Medicines Agency. Castle predicts that the EMA is inevitably going to leave the UK. “Given the strength of feeling on immigration,” it looked unlikely the country would opt for a European Economic Area relationship, since that would mean continuing ...

FDA Issues Draft Guidance on Voluntary Sodium Reduction Targets

On June 1, 2016, the FDA announced draft guidance on voluntary sodium reduction targets that could have a substantial effect on food manufacturers and restaurants. The Draft Guidance proposes short-term and long-term targets for various categories of commercially processed, packaged, and prepared foods, as well as recommended upper bounds for sodium in each food ...

FDA Issues Final Rule to Protect Food from Intentional Adulteration

On May 27, 2016, FDA finalized its seventh and final food safety rule under the Food Safety Modernization Act (FSMA), which will become new 21 C.F.R. Part 121. The Intentional Adulteration rule establishes requirements to help protect food against adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism. For the ...

FDA Stirs Debate Over Labeling Authority With Sugar Rule

Miriam Guggenheim is quoted in a Law360 article regarding the FDA’s new rule requiring companies to include information about added sugars on nutrition labels. According to Guggenheim, "There will be those who assert that FDA has not met its First Amendment burden to justify the compelled commercial speech." She continues, "A number of recent cases have ...

FDA Issues Final Rules on Changes to Nutrition Labels

On Friday, May 20, 2016, FDA issued two final rules to revise the nutrition labeling requirements for conventional foods and dietary supplements—the first major revisions to the nutrition labels since they were originally required over 20 years ago. Recognizing a shift in the average American’s consumption habits and understanding of the Nutrition Facts label, ...

FDA Finalizes Guidance for Industry about Medical Foods

Last week, FDA finalized its guidance for industry about medical foods, which it issued in draft form in August 2013. This guidance incorporates most of the principles that FDA articulated in the 2013 draft guidance regarding the agency’s position on the definition of medical foods, the scope of lawful uses of medical foods, and other labeling and safety ...

UK would lose two pharma bodies in event of Brexit, lawyers warn

Peter Bogaert and Grant Castle are quoted in a Financial Times article regarding the effect Brexit would have on the UK pharma industry. According to Bogaert, commenting on the important relationship between the European Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency, “Brexit would be a loss for both sides.” Castle adds that ...

Navigating the Muddy Waters of Chinese Device Regulations

John Balzano’s remarks from an FDAnews webinar are quoted extensively in this article on changes to Chinese device regulations. According to Balzano, it is important to consider a host of issues, such as whether the device will be manufactured in China. Understanding the finer points of the Chinese FDA guidances "can influence whether your application gets ...

Non-TAA-Compliant Covered Drugs Must be Offered to the VA in the Coming Weeks

The United States Department of Veterans Affairs (“VA”) recently announced a significant change in policy that will allow it to purchase drug products that were previously unavailable due to the Trade Agreements Act (“TAA”) because they were manufactured in countries with whom the United States does not have a procurement agreement in place. The VA has issued a ...

First Year in Review: Top Ten Things to Know about Biosimilar Reimbursement in the U.S.

It has now been a full year since the Food and Drug Administration (“FDA”) approved the first biosimilar product to proceed under the new abbreviated biological pathway. With recent spotlights on the cost of pharmaceutical drug products, the potential of biosimilars to offer patients additional and more affordable choices has been widely discussed. Most ...

FDA Publishes Final Rule on Sanitary Transportation of Human and Animal Food

Yesterday, FDA published in the Federal Register its final rule establishing sanitary transportation requirements for both human and animal food. The rule is intended to ensure that food transportation practices do not create food safety risks. FDA provides a flexible, risk-based approach that largely aims to allow the transportation industry to continue to use ...

EU Enforcement of the Nagoya Protocol on Use of Genetic Resources

Strict EU rules enforce compliance with the principles on access and benefit sharing under the Nagoya Protocol. The rules affect all companies doing research on genetic resources, such as plants, bacteria and viruses, and related traditional knowledge. They in particular are relevant for the pharmaceutical, medical devices, cosmetics, biocides and foods ...

Covington Represents Underwriters in Senseonics' IPO

NEW YORK - Covington advised the underwriters in the $45 million initial public offering of common stock of Senseonics Holdings, Inc. The offering closed on March 23, 2016. Shares of Senseonics trade on the NYSE MKT under the ticker “SENS.” Senseonics develops continuous glucose monitoring systems for patients with diabetes. Its Eversense product consists of ...

Downer? Could the UK Psychoactive Substances Act spell disaster for the food & supplements industry?

Brian Kelly is quoted extensively in this Nutra Ingredients article discussing the UK Psychoactive Substances Act and its possible effect on the food supplements industry. According to Kelly, “Despite criticism and proposed amendments about unintended targets the law has been pushed through. It’s a poorly drafted law when it comes to food.” He continues, “You ...

Fate of EU drugs agency hangs in Brexit balance

Grant Castle and Robin Blaney are quoted in this Politico article discussing the potential impact of “Brexit” on the pharmaceutical sector in the UK and Europe. According to Castle, the “only rational alternative” to EU membership is for the U.K. to become a member of the European Economic Area, as this arrangement would make it so the practical and operational ...

Summary of FDA Advertising and Promotion Enforcement Activity in 2015

This e-alert is part of a series of alerts summarizing publicly-available FDA enforcement letters relating to the advertising and promotion of prescription drugs, medical devices, and biologics. This alert reviews warning and untitled letters issued in 2015. In 2015, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following letters on FDA’s ...

Covington Advises Allergy Therapeutics on £11.5 Million Placement and License Agreement

LONDON, November 23, 2015 — Covington represented Allergy Therapeutics, the AIM-listed specialty pharmaceutical company specializing in allergy vaccines, in the placement of ordinary shares raising approximately £11.5 million. The placement was conducted through an accelerated bookbuilding process with Panmure Gordon & Co acting as financial adviser, nominated ...

Former FDA Chief of Staff and Deputy Chief Counsel Joins Covington

WASHINGTON, DC, November 9, 2015 - Denise Esposito, who served as Chief of Staff to the Commissioner of the US Food and Drug Administration and FDA’s Deputy Chief Counsel for drugs and biologics, has joined Covington as a partner and co-chair of its Food & Drug practice group. “Denise has played a central role on issues of critical importance to our clients in ...

Covington Advises Regeneron on New Immuno-Oncology Collaboration

WASHINGTON, DC, July 29, 2015 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the field of immuno-oncology. Sanofi has committed to an initial investment of up to $2.17 billion in the exclusive collaboration, including $640 million in ...

Covington Secures Victory for Amarin Against FDA

WASHINGTON, DC, May 29, 2015 — Covington scored a victory for Amarin Pharmaceuticals Ireland Limited this week when a federal judge vacated the U.S. Food and Drug Administration’s earlier decision that Amarin’s new drug Vascepa was not entitled to a five-year period of market exclusivity. It is the first known successful challenge to FDA’s denial of ...

Covington Represents Underwriters in Cidara IPO

NEW YORK — Covington advised the underwriters in the $76.8 million initial public offering of common stock of Cidara Therapeutics, Inc. Shares of Cidara trade on the NASDAQ Global Market under the ticker “CDTX.” Cidara is a biopharmaceutical company focused on the discovery, development and commercialization of anti-infectives for treatment of diseases ...

Litigators of the Week: Paul Schmidt and Michael Imbroscio of Covington & Burling

Covington's Paul Schmidt and Michael Imbroscio were named "Litigators of the Week" by AmLaw for their successful representation of Hoffmann-La Roche Inc.: "Not so long ago, Hoffmann-La Roche Inc. faced a grim reality in sprawling litigation over the acne medication Accutane." "In 2007, New Jersey judge Carol Higbee handed an edge to plaintiffs lawyers at ...

Covington’s Peter Safir Receives FDLI Distinguished Service and Leadership Award

WASHINGTON, DC, December 8, 2014- The Food and Drug Law Institute (FDLI) has named Covington & Burling partner Peter Safir a recipient of its 2014 Distinguished Service and Leadership Award. The annual awards honor four outstanding leaders in the food and drug law community.Mr. Safir, co-chair of Covington’s food and drug practice group, has been practicing in ...

Covington Advises Illumina on Partnership with Genomics England

LONDON, 5 August, 2014 — Covington & Burling advised Illumina on its partnership with Genomics England to provide infrastructure and expertise for a four-year project that aims to make the UK the world leader in genetic research into cancer and rare diseases, through funding research to decode 100,000 human genomes - a patient's personal DNA code. The deal is ...

China Looks Closer At Enforcement Of Meat Product Regulations

Covington's John Balzano writes on the safety issues with meat production in his blog for Forbes Asia. "Safety issues with the meat and meat products in China are causing controversy again. Last year a group of diseased pig carcasses came floating into rivers near Shanghai, causing concern about black markets for meat spreading foodborne illnesses. This time ...

Fighting 'Superbugs' With Next Generation Antibiotics

Dan Speigel and Anne Pence co-authored this article on the use of antibiotics. "Alarmed by the real health, economic and security risks associated with “superbugs” that are resistant to antibiotics — the lynchpins of modern medicine — President Obama has included anti-microbial resistance as a focus of his 26-nation partnership Global Health Security Agenda. He ...

China's Elusive Pet Food Regulation

Covington's John Balzano writes on Chinese pet food regulation for Forbes. "Long-term, all-too-frequent, and severe safety issues with pet treats and pet food coming from China have led to serious questions about the state of China’s pet food regulations. The answer to those questions may be fairly simple: China does not have a significant body of pet food ...

Covington’s Doebler to Receive Klepper Prize for Volunteer Excellence

WASHINGTON, DC, March 4, 2014 —The Legal Aid Society of the District of Columbia has awarded Stefanie Doebler its Klepper Prize for Volunteer Excellence, which recognizes lawyers early in their careers who have made a significant volunteer contribution to the Society. Ms. Doebler, special counsel in Covington & Burling’s health care and food and drug practice ...

Covington Wins Six LMG Life Sciences Awards

NEW YORK, September 27, 2013 — Covington & Burling received six awards at the inaugural LMG Life Sciences awards on September 25, including “FDA Pharmaceutical Firm of the Year” and Richard Kingham’s induction to the Hall of Fame. The awards, which are selected based on a survey of peers and leading companies in the life sciences industry, “recognize and honor ...

Covington Advises Canaccord Genuity Ltd and WG Partners on Lombard Medical Fundraising

LONDON, 20 June, 2013 — Covington & Burling acted for Canaccord Genuity Limited (nominated adviser and joint broker) and WG Partners, a trading name of Charles Stanley & Co. Ltd (joint broker), to AIM-quoted Lombard Medical Technologies plc on its placing and subscription of ordinary shares to raise approximately £22 million before expenses. Lombard is a ...

Top Environmental Lawyer Don Elliott Joins Covington

WASHINGTON, DC, January 8, 2013 — E. Donald Elliott, a leading environmental and administrative lawyer and scholar, has joined Covington & Burling, strengthening the firm’s top-ranked environmental and product liability practices. Mr. Elliott has more than 30 years of experience in environmental law, administrative law and product liability and toxic torts. He ...

Covington Advises Illumina in Acquisition of Verinata Health

NEW YORK, January 7, 2013 — Covington & Burling advised Illumina, Inc. on its announced acquisition of Verinata Health, Inc. for cash consideration of $350 million plus up to $100 million in milestone payments through 2015. Upon completion of the acquisition, Illumina will have access to the Verinata’s verifi® prenatal test, the broadest non-invasive prenatal ...

U.S. News-Best Lawyers Again Ranks Covington Among Nation's Top Law Firms

WASHINGTON, DC, November 7, 2012 — Covington & Burling received 97 first-tier practice rankings in the 2013 “Best Law Firms” survey by U.S. News-Best Lawyers, placing Covington among the top 10 firms nationwide. Covington was also named “Law Firm of the Year” in both FDA Law and Corporate Compliance Law. The honor is presented to one law firm in each of the ...

Covington Promotes 15 Lawyers to Partnership

WASHINGTON, DC, October 1, 2012 — Covington & Burling is pleased to announce that it has elected 15 new lawyers to its partnership. This group is comprised of diverse and talented individuals from five offices who have made their mark at the firm through exceptional work and the highest standards of client service. “We’re delighted to welcome these 15 lawyers to ...

Seven Covington Lawyers Named ‘2013 Lawyer of the Year’

WASHINGTON, DC, September 13, 2012 — Best Lawyers in America named seven Covington & Burling lawyers today as “2013 Lawyer of the Year” in their respective practice areas and cities. The selected lawyers received strong ratings from their peers for their “abilities, professionalism and integrity,” in the publication’s annual survey. Best Lawyers recognizes only ...

Covington Advises Meda on Acquisition of Jazz Pharmaceuticals’ Women’s Health Products

LONDON, 06 September, 2012 — Covington & Burling LLP acted as legal advisers to Meda in an agreement with Jazz Pharmaceuticals to acquire a portfolio of six pharmaceutical products for women for $95 million in cash. The largest and most important product in the portfolio is Elestrin, a patented product with sales of almost 100 MSEK, that doctors prescribe for ...

Covington Receives 196 Individual Mentions in 2013 Edition of Best Lawyers

WASHINGTON, DC, August 27, 2012 — Covington & Burling LLP lawyers received 196 individual mentions in 57 areas of law in the 2013 edition of The Best Lawyers in America. This annual compilation of top U.S. lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as ...

Covington Advises AstraZeneca in Agreement with Pfizer for OTC Nexium

WASHINGTON, DC, August 14, 2012 — Covington & Burling advised AstraZeneca in its agreement with Pfizer for over-the-counter rights to sell a nonprescription version of Nexium, a medication prescribed to treat the symptoms of gastroesophageal reflux disease. The agreement gives Pfizer rights to sell a 20mg nonprescription version of AstraZeneca's Nexium ...

Q&A With Covington's Gerald Masoudi

Gerald Masoudi is featured in a Q&A with Law360 discussing the trends from food and drug matters and the recent updates from the FDA. In the first question, “What is the most challenging case you have worked on and what made it challenging?,” Mr. Masoudi says: “While I was chief counsel at FDA, I was involved in cases raising the question of whether ...

Covington Advises Ascom Holding in Medical Device Acquisition

NEW YORK, June 22, 2012 — Covington & Burling advised Ascom Holding AG in its acquisition of GE Healthcare’s nurse call medical device business. The acquisition gives Ascom access to the North American nurse call market and creates opportunities to combine GE Nurse Call systems with Ascom’s existing mobility offering. With this acquisition, Ascom further ...

Covington’s Peter Bogaert Named ‘2012 Lawyer of the Year’

BRUSSELS, 24 May, 2012 — Best Lawyers in Belgium has named Covington & Burling partner Peter Bogaert as the 2012 Brussels “Lawyer of the Year” in the regulatory category for his “abilities, professionalism and integrity.” Best Lawyers recognises one lawyer in each practice area and region. Mr. Bogaert has a broad European life sciences practice. He has detailed ...

Covington Lawyers Recognized by D.C. Super Lawyers

WASHINGTON, DC, May 2, 2012 — D.C. Super Lawyers selected 64 Covington & Burling lawyers for its 2012 list of top legal talent. Super Lawyers selects no more than five percent of the total lawyers who practice in Washington based on peer review and the publication’s independent research. Deborah Garza and Robert Long have been named among the “Top 100” for ...

Covington Advises AstraZeneca in $1.26 Billion Acquisition of Ardea Biosciences

WASHINGTON, DC, April 23, 2012 — Covington & Burling represented AstraZeneca in its $1.26 billion acquisition of Ardea Biosciences. Under the agreement, AstraZeneca will pay $32 per share for all of the outstanding shares of Ardea. AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and ...

Covington to Open Seoul Office, Adds William H.Y. Park

WASHINGTON, DC, March 12, 2012 — Covington & Burling LLP has applied to open a new office in Seoul and tapped William H.Y. Park, a veteran corporate lawyer based in Korea, to help oversee the expansion. Mr. Park will work closely with former Ambassador to the United Nations Daniel Spiegel, senior of counsel at Covington, who will be the Foreign Legal Consultant ...

Washingtonian Names 34 Covington Attorneys ‘Best Lawyers’

WASHINGTON, DC, November 30, 2011 — Washingtonian magazine has named 34 Covington & Burling attorneys as “Best Lawyers” in its December issue. The biennial list, compiled by the magazine’s editorial staff, identifies leading lawyers in the Washington area. Of the approximately 800 “Best Lawyers” identified in the issue, Washingtonian included profiles of 31 ...

Covington Advises Salix Pharmaceuticals in $300M Acquisition of Oceana Therapeutics

WASHINGTON, DC, November 10, 2011 — Covington & Burling represented Salix Pharmaceuticals, Ltd. in its agreement to acquire Oceana Therapeutics, Inc., a privately held global provider of gastroenterology and urology therapeutics, for $300 million in cash. “The acquisition of Oceana expands our product portfolio of innovative products, furthers the ...

U.S. News-Best Lawyers Awards Covington ‘Law Firm of the Year’ in FDA Law and 82 First-Tier Practice Rankings

WASHINGTON, DC, November 1, 2011 — For the second consecutive year, U.S. News-Best Lawyers awarded Covington & Burling the most first-tier practice rankings for Washington, DC in the “Best Law Firms” survey. The 2011-12 survey also awarded the firm 82 first-tier practice rankings, placing Covington among the top 20 firms nationwide. Additionally, U.S. ...

Eight Covington Lawyers Named ‘2012 Lawyer of the Year’

WASHINGTON, DC, October 5, 2011 — Best Lawyers named eight Covington & Burling lawyers as the “2012 Lawyer of the Year” in their respective practice areas and cities. According to Best Lawyers, the selected lawyers have received particularly strong ratings in the Best Lawyers' survey by earning a high level of respect among their peers for their “abilities, ...

Covington Promotes 10 Lawyers to Partnership

WASHINGTON, DC, October 3, 2011 — Covington & Burling LLP announced today that 10 of its lawyers have been elected to the firm’s partnership effective October 1. This group is comprised of diverse and talented individuals who have made their mark at Covington through exceptional work and the highest standards of client service. “We’re delighted to welcome these ...

Covington Receives 184 Individual Mentions in 2012 Edition of Best Lawyers

WASHINGTON, DC, September 7, 2011 — Covington & Burling LLP lawyers received 184 individual mentions in 56 areas of law in the 2012 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: ...

Covington Advises Bristol-Myers Squibb in $325M Acquisition of Amira Pharmaceuticals

NEW YORK, July 22, 2011 — Bristol-Myers Squibb Company and Amira Pharmaceuticals, Inc., have reported that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire privately held Amira Pharmaceuticals. Covington & Burling LLP represented Bristol-Myers Squibb in the transaction. Under the terms of the agreement, ...

Chambers USA Recognizes Covington with 123 Individual, 45 Practice Nods

WASHINGTON, DC, June 10, 2011 — Covington & Burling LLP received 123 individual mentions and 45 practice mentions in Chambers USA 2011. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...

Covington Advises Forest on Acquisition of Clinical Data, Inc.

NEW YORK, February 22, 2011 — Forest Laboratories, Inc. (NYSE: FRX) and Clinical Data, Inc. (NASDAQ: CLDA) announced today that they have entered into a merger agreement pursuant to which Forest will acquire Clinical Data, a specialty pharmaceutical company focused on the development of first-in-class and best-in-category therapeutics. Covington & Burling LLP ...

Covington Advises Charlesbank on Acquisition of Peacock Engineering Company

NEW YORK, January 6, 2011 — Charlesbank Capital Partners has announced that it has acquired Peacock Engineering Company, LLC, a leading provider of outsourced food packaging and supply chain management services to many of the nation’s largest branded consumer products companies, from Behrman Capital. The terms of the transaction, which closed on December 21, ...

Covington Advises Colbeck Capital Management on Kadmon Pharmaceuticals Acquisition

NEW YORK, October 25, 2010 — Kadmon Pharmaceuticals announced today that it has acquired Three Rivers Pharmaceuticals, a privately held specialty pharmaceuticals company based in Warrendale, Pennsylvania. Three Rivers will serve as the commercial and operational cornerstone for Kadmon, a privately held biopharmaceutical company based in New York City. Terms of ...

Covington Advises King Pharmaceuticals on $3.6B Merger with Pfizer

NEW YORK, October 12, 2010 — King Pharmaceuticals and Pfizer announced today that they have entered into an agreement for Pfizer to acquire all of the outstanding stock and stock equivalents of King for $14.25 in cash per share, or aggregate consideration of $3.6 billion. Covington & Burling LLP advised King on the transaction. King is a vertically integrated ...

Covington Receives First-Tier Practice Nods in Inaugural “Best Law Firms” Rankings by U.S. News and Best Lawyers

WASHINGTON, DC, September 17, 2010 — Covington & Burling LLP received 33 first-tier practice rankings in the 2010 “Best Law Firms” survey by U.S. News Media Group and Best Lawyers. Covington’s first-tier national rankings place it among the top 10 firms nationwide and at the top of the first-tier rankings for Washington, DC. The inaugural rankings presented in ...

Covington Receives 138 Individual Mentions in 2011 Edition of Best Lawyers

WASHINGTON, DC, August 6, 2010 — Covington & Burling LLP received 138 individual mentions in 40 areas of law in the 2011 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: Administrative: ...

Covington Advises Gilead Sciences on Acquisition of CGI Pharmaceuticals

NEW YORK, June 25, 2010 — Gilead Sciences, Inc. and CGI Pharmaceuticals, Inc. today announced the signing of a definitive agreement pursuant to which Gilead will acquire CGI. Under the terms of the agreement, Gilead will acquire CGI for up to $120 million, the majority as an upfront payment and the remaining based on clinical development progress. Covington & ...

Chambers USA Recognizes Covington with 112 Individual, 44 Practice Nods

WASHINGTON, DC, June 16, 2010 — Covington & Burling LLP received 112 individual mentions and 44 practice mentions in Chambers USA 2010. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...

Covington Advises Intercell on Acquisition of Antibody Technology Platform

LONDON, 6 May, 2010 — Intercell AG today announced that it has signed an agreement with Cytos Biotechnology Ltd. to acquire Cytos’ platform technology for monoclonal antibody discovery. The technology is based on expression cloning of monoclonal antibodies from human B-cells and enables the identification of anti-infective antibodies to prevent and treat ...

Assistant U.S. Trade Representative for China Affairs Stratford Joins Covington

WASHINGTON, DC, February 22, 2010 — Covington & Burling LLP is pleased to announce that Timothy P. Stratford, who most recently served as Assistant U.S. Trade Representative (USTR) for China Affairs, has joined the firm as a partner. He will be resident in the firm’s Beijing office and will practice in the International Trade and Finance group. Mr. Stratford’s ...

Covington Advises Minster Pharmaceuticals in Recommended Takeover by Proximagen Neuroscience

LONDON, January 15, 2010 — Covington & Burling LLP advised Minster Pharmaceuticals plc, the AIM-quoted drug development company specialising in compounds for the treatment of neurological and psychiatric conditions, in its recommended takeover by Proximagen Neuroscience plc. The terms of the all cash offer value Minster at £4.3 million. The Covington team ...

Washingtonian Names 25 Covington Attorneys ‘Top Lawyers’

WASHINGTON, DC, November 23, 2009 — Twenty-five Covington & Burling LLP attorneys are recognized as “Top Lawyers” in the December issue of Washingtonian magazine. The list, compiled by the magazine’s editorial staff, identifies leading lawyers in the Washington area. Of the “Top Lawyers,” Washingtonian identified 30 as “stars of the bar.” Among them is Michael ...

Covington Promotes 10 Lawyers to Partnership

WASHINGTON, DC, October 1, 2009 — Covington & Burling LLP today announced that ten of its lawyers have been elected to the firm’s partnership effective today. The new partners practice in the corporate, litigation, and regulatory fields. The ten new partners and their practices are as follows: Marney Cheek (International) represents companies and trade ...

Covington Receives 131 Individual Mentions in 2010 Edition of Best Lawyers

WASHINGTON, DC, August 7, 2009 — Covington & Burling LLP received 131 individual mentions in 38 areas of law in the 2010 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: Administrative: ...

Covington Advises Medarex on $2.4B Merger with Bristol-Myers Squibb

NEW YORK, NY, July 22, 2009 — Medarex and Bristol-Myers Squibb announced today that Bristol-Myers Squibb entered into an agreement for Bristol-Myers Squibb to acquire all of the outstanding stock and stock equivalents of Medarex for $16.00 in cash per share, or aggregate consideration of $2.4 billion. Covington & Burling LLP advised Medarex on the ...

Chambers USA Recognizes Covington With 100 Individual, 40 Practice Nods

WASHINGTON, DC, June 12, 2009 — Covington & Burling LLP received 100 individual mentions and 40 practice mentions in Chambers USA 2009. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...

Covington Acts for Piper Jaffray in a £24m Fundraising by Vernalis

LONDON, May 19, 2009 — Vernalis plc, the London main market listed pharmaceutical company which is developing a pipeline of clinical and early stage programmes, today announced the completion of a placing and open offer raising £24 million before expenses. It proposes to apply the proceeds of the fundraising to fund its clinical development and discovery ...

Covington Expands European Life Sciences Transactions Practice with Daniel Pavin

LONDON, May 14, 2009 — Covington & Burling LLP is pleased to announce the arrival of Daniel Pavin, who joins the firm’s leading European life sciences practice as a partner in London. Mr. Pavin is recognized as a leading life sciences transactional lawyer in the UK and Europe and brings extensive experience in the life sciences and healthcare sectors. He ...

Covington Advises Salix Pharmaceuticals in In-License from Napo Pharmaceuticals

WASHINGTON, DC, December 11, 2008 — Salix Pharmaceuticals, Ltd. announced that it has acquired rights to crofelemer from Napo Pharmaceuticals, Inc. Covington & Burling LLP represented Salix in the deal. Crofelemer currently is being investigated in a Phase 3 study as an anti-diarrheal agent for the treatment of chronic diarrhea in people living with HIV. Salix ...

Covington Advises Memory Pharmaceuticals in Acquisition by Roche

NEW YORK, NY, December 2, 2008 — Roche and Memory Pharmaceuticals have announced a definitive merger agreement for Roche to acquire all the outstanding shares of Memory Pharmaceuticals. Covington & Burling LLP advised Memory Pharmaceuticals on the deal, valued at approximately $50 million. Roche, headquartered in Switzerland, is one of the world’s leading ...

Covington Promotes 12 Lawyers to the Partnership

WASHINGTON, DC, October 1, 2008 — Covington & Burling LLP today announced that 12 of its lawyers have been elected to the firm’s partnership. These new partners are resident in four of the firm’s offices and practice in the litigation, corporate/tax, and regulatory fields. Timothy Hester, chair of the firm’s management committee, commented: “These young and ...

Covington Receives 124 Individual Mentions in 2009 Edition of Best Lawyers

WASHINGTON, DC, September 29, 2008 — Covington & Burling LLP received 124 individual mentions in 40 areas of law in the 2009 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: Administrative: ...

Chambers USA Gives Covington 81 Individual, 45 Practice Nods

WASHINGTON, DC, June 16, 2008 — Covington & Burling LLP received 81 individual mentions and 45 practice mentions in the newly released 2008 Chambers USA. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington ...

Covington Announces Nine New Counsel

WASHINGTON, DC, April 3, 2008 — Covington & Burling LLP has announced the promotion of four new of counsels and five new special counsels in the firm’s five offices. The new of counsels are as follows: Christopher Denig (Washington) focuses on representing clients in complex federal civil litigation (including class actions), internal corporate ...

Covington Secures D.C. Circuit Victory Dismissing Class Action Against Milk Sellers

WASHINGTON, DC, December 7, 2007 — The U.S. Court of Appeals for the D.C. Circuit has affirmed the dismissal of a class-action lawsuit challenging the absence of warning labels on milk informing consumers of the purported risks of lactose intolerance. Covington & Burling LLP successfully represented the defendants, which included Giant of Maryland, Nestle ...

Washingtonian Magazine Names 19 Covington Attorneys ‘Top Lawyers’

WASHINGTON, DC, November 30, 2007 — Nineteen Covington & Burling LLP attorneys are recognized as “Top Lawyers” in the December 2007 issue of Washingtonian magazine. The list, compiled by the magazine’s editorial staff based on peer recommendations, identifies leading lawyers in the Greater Washington area. Of the “Top Lawyers,” Washingtonian identified 30 as the ...

Covington Elects Six New Partners

WASHINGTON, DC, October 1, 2007 — Covington & Burling LLP announced that six of its associates have been elected to the firm’s partnership, effective today. Stuart Stock, chair of the firm’s management committee, commented, “These six outstanding men and women are representative of Covington’s depth and excellence. We are pleased to welcome them to our ...

Covington Receives 115 Individual Mentions in 2008 Edition of Best Lawyers

WASHINGTON, DC, September 6, 2007 — Covington & Burling LLP received 115 individual mentions in 38 areas of law in the 2008 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The recipients are as follows: Administrative: E. Edward Bruce and ...

Covington Receives 44 Practice, 74 Individual Mentions in 2007 Chambers USA Guide

WASHINGTON, DC, June 18, 2007 — Covington & Burling LLP received 44 practice mentions and 74 individual mentions in the newly released 2007 Chambers USA guidebook. The 2007 edition of Chambers USA attempts to identify the most skilled legal practitioners throughout the country based on the qualities most valued by clients. Covington attorneys have been ...

Covington Advises Pfizer in Acquisition of BioRexis

NEW YORK, NY, February 1, 2007 — Covington & Burling LLP advised Pfizer in the acquisition of BioRexis, a privately held biopharmaceutical company. The transaction is expected to close in the first or second quarter of 2007. The financial terms of the transaction were not disclosed.BioRexis is developing long-acting GLP-1 receptor agonists for the potential ...

Covington Advises Abbott Laboratories in $3.7 Billion Acquisition of Kos Pharmaceuticals, Inc.

NEW YORK, NY, November 6, 2006 — Abbott Laboratories (NYSE: ABT) announced the acquisition of Kos Pharmaceuticals (NASDAQ: KOSP) through a cash tender offer of $78.00 per common share, or $3.7 billion. Covington & Burling LLP represented Abbott in the transaction. Abbott is a global, broad-based health care company devoted to the discovery, development, ...

Covington Represents Eisai In $205 Million Acquisition of Four Oncology-Related Products

WASHINGTON, D.C., September 13, 2006 — Covington represented both Eisai Co., Ltd. and Eisai Inc. in the recent $205 million product acquisition agreement with Ligand Pharmaceuticals. Eisai obtained exclusive global rights to four products, including ONTAK®, Targretin® capsules, Targretin® 1% gel and Panretin® 0.1% gel. This acquisition will help to ...

Covington advises Novartis Vaccines on New Flu Cell Culture Facility Intended to Produce Vaccine for Influenza Including Avian or "Bird" Flu

WASHINGTON, D.C., July 25, 2006 - Covington advised Novartis Vaccines and Diagnostics, Inc. (successor to Chiron Corporation) in its plans to locate, construct and operate a cell culture-derived influenza vaccines manufacturing facility in Holly Springs, North Carolina. The facility, slated to be the first of its kind in the United States, should ...

Covington Advises Procter & Gamble in Alliance with ARYx Therapeutics

SAN FRANCISCO, July 20, 2006 - The San Francisco office of Covington & Burling LLP advised Procter & Gamble Pharmaceuticals, Inc., a division of The Procter & Gamble Company, in its strategic alliance with ARYx Therapeutics, a private drug discovery and development company based in Fremont, CA. Under the terms of the agreement, P&G will develop and ...

Covington Advises Emergent BioSolutions on Major R&D Collaboration Agreement with sanofi pasteur

LONDON, June 6, 2006 - Emergent BioSolutions, a privately-held biopharmaceutical company, has signed an agreement with sanofi pasteur, the vaccines business of the sanofi-aventis Group, to develop a critically-needed vaccine to prevent one of the world's deadliest childhood diseases, serogroup B meningitis. The Covington team that advised Emergent BioSolutions ...

Leading Intellectual Property Litigator, Simon J. Frankel, Joins Covington as Partner

SAN FRANCISCO, CA, April 6, 2006 - Covington & Burling announced today that Simon J. Frankel will join the firm's intellectual property litigation group as a partner. Mr. Frankel will be resident in the firm's San Francisco office. Mr. Frankel's extensive IP litigation experience includes handling trademark, copyright, patent, anti-counterfeiting, and trade ...

Covington Represented AstraZeneca in Collaboration Agreement with Targacept

WASHINGTON, D.C., January 19, 2006 - Covington & Burling represented AstraZeneca AB in its recent global licensing and research collaboration agreement with Targacept Inc. Under the terms of the agreement, which is subject to the expiration or termination of the HSR (Hart Scott Rodino) clearance period in the US, AstraZeneca will obtain the global rights for ...

Peter Hutt & Peter Safir Recognized in Legal Times Profile of Top Food & Drug Lawyers

WASHINGTON, D.C., September 22, 2005 - Covington & Burling lawyers Peter Barton Hutt and Peter Safir were featured as two of Washington's top eleven Leading Food & Drug Lawyers in this week's edition of Legal Times. Covington was the only firm to have two lawyers recognized. In describing Mr. Hutt's reputation as a standout in the field, the Legal Times ...

Peter O. Safir, Leading Food & Drug Regulatory Lawyer, Joins Covington & Burling as a Partner

October 1, 2002 - WASHINGTON, D.C. - International law firm Covington & Burling is pleased to announce that Peter O. Safir has joined as a partner. Mr. Safir has been practicing in the food and drug field for nearly 30 years. He is widely recognized in the pharmaceutical industry as one of the leading food and drug regulatory lawyers in the country. In recent ...

U.S. District Court Rules Medical Marijuana Initiative Should Proceed

March 28, 2002 - Washington, D.C.- In a historic ruling issued today, federal judge Emmet G. Sullivan overturned a federal law that prohibited District of Columbia residents from proposing, running, and voting on a ballot initiative to legalize marijuana for medical purposes. The decision resolved a First Amendment lawsuit against the federal government and the ...

Lawyers credit FDA dietary supplements office for improved communications

Natural Products Insider included Miriam Guggenheim’s remarks from a recent event hosted by the Council for Responsible Nutrition. . Ms. Guggenheim, who served on a panel about areas in which the Office of Dietary Supplement Programs (ODSP) is faring well since its creation in December 2015, Ms. Guggenheim suggested the relationship has improved between ODSP ...

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The only firm recognized by Chambers as a “Band 1” firm for Life Sciences across their US, UK, Europe, China and Global surveys
Awarded “FDA Law Firm of the Year” by U.S. News & World Report in 2015, and “Life Sciences Practice Group of the Year” by Law360 in 2012, 2013, and 2014
Recognized as a leading food, drug and device regulatory firm by Chambers, Legal 500, Law360 and LMG Life Sciences
More than a dozen individual attorneys recognized for excellence in food, drug and device regulatory work by the leading legal industry surveys

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Food, Drug, and Device

Representative Matters

Kentucky Fried Chicken (KFC) against False Advertising Claims

King Pharmaceuticals Acquisition by Pfizer

Kos Pharmaceuticals Medicare Part D coverage

Leading Food and Pharmaceutical Manufacturers on Advertising Requirements

Bacardi Transaction

AbbVie/Calico $1.5B collaboration

Legislative Victory in a 2016 FDA Nutrition Facts Panel Rule

NICE Challenge for Irish Biopharmaceutical Company

EU and U.S. Food Regulatory Requirements and Approvals

Meretek Diagnostics ITC Section 337 Investigation

Nidek ITC Section 337 Investigation

Co-lead counsel for POM Wonderful

Concurrent House and Senate investigations

Deep experience

FDCA, FTC Act, and Lanham Act Compliance for life sciences companies

Advertising of “Functional Foods”

Animal Drug Regulation

Animal Feed and Pet Food Ingredient Regulation

Animal Health FDA Enforcement

Animal Health Product Import Issues

Animal Welfare Act Investigations and Compliance

Anti-kickback safe harbors

AstraZeneca/Bristol-Myers Squibb diabetes alliance

AstraZeneca in $1.26 Billion Acquisition of Ardea Biosciences

Biopharmaceutical Legislation Representation

China Biopharmaceutical Regulatory and Legal Strategy

China Device Regulatory and Clinical Trial Advice

China licensing and collaboration

China licensing and joint venture

China life sciences transactional

China life sciences transactional

China Online Drug Information Regulation

China Medical Device Acquisition Due Diligence

China pharma bribery investigation

China Regulatory and Compliance

CIA Sales and Marketing Compliance

Deceptive Marketing and Consumer Protection Defense

EU Regulation of Cosmetics Testing on Animals

False Claims Act litigation and appellate defense

FDA Food Labeling Comments

FDCA Amendments Legislation

Food and Cosmetics Labeling Class Actions

Food Contamination Litigation

Food Safety and Health Benefits Claims Advocacy and Implementation

FSMA Advocacy

GMP Consent Decree Negotiations

Hatch-Waxman settlement investigation and class action

Health Benefit Claim Substantiation Defense

Health Benefit Claims Investigation

Health IT, LDT Regulatory Advocacy

Healthcare business corporate structure and governance

In re K-Dur Antitrust Litigation

International Dairy Foods Association against Class Action

Internet and Social Media Promotion Advice

Over-the-counter medicine investigation

Off-label marketing investigation

Senate Finance Committee investigation

Genetic diagnostics strategic alliance

Medicaid coverage for dropped products

Merck Merger with Schering-Plough

New Animal Health Business Development

Numerous Clients in Managing U.S. and Global Trademark Portfolios

Off-label promotion and reporting investigations

PCPC Outside Counsel

Position Paper Concerning Potential Amendments

Prescription drug user privacy litigation

Promotional Materials SOPs and Guidelines

Representation of an international beverage company in LCIA and UNCITRAL arbitrations

Reversal of FDA denial of period of exclusivity

Salix Pharmaceuticals in $2.6 Billion of Santarus, Inc.

Specialty Pharma cross-border licensing agreement

Advice to Numerous Life Sciences Companies on Regulatory Compliance and Infrastructure

Victory for BMS and Eli Lilly in Copyright Infringement Matter

Case Challenging a Negative Reimbursement Decision before the Irish High Court

Litigation risk counseling

Trade association guidance

News and Insights (Showing 5 of 847) (Showing 847 of 847)