Food, Drug, and Device

May 26, 2020, Covington Alert

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 ...

May 22, 2020, Covington Alert

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 ...

May 21, 2020, Covington Alert

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 ...

May 20, 2020, Financial Times

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 ...

May 20, 2020, Covington Alert

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 ...

May 18, 2020, Covington Alert

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 ...

May 18, 2020, Covington Alert

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 ...

May 15, 2020, Covington Alert

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 ...

May 14, 2020, Covington Alert

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, ...

May 14, 2020, Covington Alert

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 ...

May 8, 2020

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 ...

May 5, 2020, Covington Alert

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) ...

May 4, 2020, Covingotn Alert

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 ...

April 30, 2020, Covington Alert

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.

April 29, 2020, Covington Alert

On March 30, 2020, the State Administration of Market Regulation of China, the parent agency of the National Medical Products Administration (NMPA), released a revised Drug Registration Regulation (Revised DRR).

April 27, 2020, Covington Alert

Since Covington’s last client alert on developments for the food industry during the COVID-19 public health crisis, FDA and USDA have posted a number of updates of interest to the industry.

April 27, 2020, Covington Alert

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 ...

April 23, 2020, Daily Journal

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 ...

April 21, 2020, Covington Alert

Since Covington’s last client alert on substantive FDA developments for the food industry during the COVID-19 public health crisis, the agency has posted a number of updates of interest to the industry.

April 6, 2020, Covington Alert

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 ...

April 6, 2020, Covington Alert

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.

April 5, 2020, Covington Alert

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 ...

April 2, 2020, Covington Alert

On March 27, the U.S. Food and Drug Administration (FDA) updated its guidance entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (Updated Guidance).

April 1, 2020, Covington Alert

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.

March 30, 2020, Covington Alert

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 ...

March 30, 2020, Covington Alert

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 ...

March 30, 2020, Covington Alert

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 ...

March 29, 2020, Covington Alert

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 ...

March 27, 2020, Covington Alert

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 ...

March 27, 2020, Covington Alert

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 ...

March 25, 2020, National Products Insider

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 ...

March 24, 2020, Covington Alert

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 ...

March 22, 2020, Covington Alert

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 ...

March 19, 2020, BioTech

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 ...

March 19, 2020, Covington Alert

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 ...

March 19, 2020, Covington Alert

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 ...

March 18, 2020, Politico

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 ...

March 11, 2020, Covington Alert

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 ...

March 6, 2020, Covington Alert

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 ...

May 2020

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 facing and develop plans and strategies in response. Reach out to our COVID-19 task force at COVID19@cov.com. Below is a compendium of resources ...

February 26, 2020, Covington Alert

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 ...

February 26, 2020, Covington Alert

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 ...

February 24, 2020, Covington Alert

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 ...

February 21, 2020, Covington Alert

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 ...

February 14, 2020, Covington Alert

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 ...

January 28, 2020

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 ...

January 21, 2020, Covington Alert

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.

January 13, 2020

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 ...

January 13, 2020, Covington Alert

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.”

January 9, 2020, Inside Health Policy

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 ...

January 2020

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 ...

December 20, 2019, Covington Alert

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.

December 19, 2019, Covington Alert

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 ...

December 9, 2019

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 ...

November 27, 2019, Covington Alert

Last week, the United States Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) published Draft Guidance for Industry No. 256, “Compounding Animal Drugs from Bulk Drug Substances” (Draft Guidance).

November 26, 2019, Covington Alert

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 ...

October 31, 2019, Covington Alert

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 ...

October 24, 2019, Covington Alert

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 ...

October 24, 2019, Covington Alert

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.

October 18, 2019, Covington Alert

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.

October 17, 2019, Covington Alert

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.

October 7, 2019, Covington Alert

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 ...

October 2, 2019, Covington Alert

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.

September 27, 2019, Covington Alert

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 ...

September 18, 2019

  📄 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 ...

September 12, 2019, Covington Alert

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.

September 10, 2019, BioWorld

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 ...

September 9, 2019, JAMA Internal Medicine

September 9, 2019, Covington Alert

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.

September 3, 2019, Covington Alert

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.

August 23, 2019, Natural Products Insider

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 ...

August 15, 2019, Natural Products Insider

Peter Hutt spoke with the Natural Products Insider podcast about the FDA’s role over the decades in regulating dietary supplements and efforts to impose restrictions that were stymied time and again.

July 18, 2019, Covington Alert

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.

July 8, 2019, Pharmaceutical Executive

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 ...

June 6, 2019, Covington Alert

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 ...

May 31, 2019, Law360

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.  

May 30, 2019, CNBC

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.”

May 8, 2019, HBW Insight

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 ...

May 6, 2019, Medtech Insight

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, ...

April 5, 2019, Law360

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.”

April 1, 2019

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 ...

March 28, 2019, Legal Week

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, ...

March 14, 2019, Covington Alert

This alert is part of a series of 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.

March 4, 2019, Covington Alert

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 ...

February 22, 2019, Covington Alert

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.”

January 31, 2019, Covington Alert

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 ...

January 10, 2019, Covington Alert

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.

2019, Global Legal Insights to: Pricing & Reimbursement 2019

December 21, 2018, Covington Alert

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.

December 13, 2018, Covington Alert

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.

November 20, 2018, Covington Alert

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.

November 6, 2018

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 ...

October/November 2018, Update (reprinted with permission from FDLI)

October 29, 2018

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 ...

October 15, 2018, Covington Alert

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 ...

September 26, 2018, Covington Alert

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.

September 19, 2018, Covington Alert

This alert is part of a series of 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.

September 5, 2018, Irish Examiner

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 ...

2018, Global Legal Insights to: Global Legal Insights - Pricing & Reimbursement 2018, 1st Ed.

August 28, 2018, Evolving Paradigms for Drug Pricing and Market Access Webinar Series

July 31, 2018, Medtech Insight

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 – ...

June 27, 2018, Nutralngredients

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 ...

June 26, 2018, The Rose Sheet

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 ...

June 25, 2018, Inside Health Policy

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 ...

June 20, 2018, Covington Alert

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”).

June 14, 2018, Covington Alert

Today, FDA issued a guidance document announcing its intention to add eight new isolated or synthetic non-digestible carbohydrates (NDCs) to the regulatory definition of “dietary fiber."

May 29, 2018, Law360

May 22, 2018, The American Lawyer

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 ...

May 18, 2018, Covington Alert

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.

May 9, 2018

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 ...

May 2018, Covington Alert

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.

May 4, 2018, Covington Alert

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 ...

April 23, 2018, The Pink Sheet

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 ...

April 2018, Digital Health Legal

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 ...

March 30, 2018, Covington Alert

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, ...

March 28, 2018

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 ...

March 27, 2018, Covington Alert

China has reorganized many of the ministries and commissions under its chief executive body, the State Council, creating a new super-ministry to replace the China Food and Drug Administration (“CFDA”) and other healthcare agencies.

March 22, 2018, Covington Alert

European General Court confirms that a new medicinal product containing the same active substance as a company’s existing medicinal product may be entitled to its own period of orphan exclusivity.

March 20, 2018, Law360

March 15, 2018, The Pink Sheet

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, ...

March 15, 2018, Covington Alert

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.

March 9, 2018, Covington Alert

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.

March 5, 2018, Covington Alert

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 ...

March 2, 2018, FDA Week

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 ...

February 27, 2018, Covington Alert

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 ...

February 14, 2018, Biocom Lunch & Learn

February 9, 2018, Covington Alert

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.

February 6, 2018

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 ...

February 5, 2018, Inside Health Policy

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.

February 2018, Digital Health Legal

January 31, 2018, Covington Alert

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 ...

January 30, 2018, Covington Alert

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 ...

January 26, 2018, Covington Alert

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 ...

January 24, 2018, Covington Alert

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 ...

January 2018, Digital Health Legal

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 ...

January 22, 2018, Covington Alert

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 ...

January 16, 2018, Covington Alert

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, ...

January 11, 2018, Covington Alert

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.

January 9, 2018, Covington Alert

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.

December 20, 2017, Covington Alert

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 ...

December 12, 2017, Covington Alert

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.

December 11, 2017, The Pink Sheet

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 ...

December 11, 2017, Better Wholesaling

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.”

December 7, 2017, Law360

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 ...

December 6, 2017

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 ...

November 21, 2017, Covington Alert

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 ...

November 17, 2017, Covington Alert

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.

November 16, 2017, Capital Hilton, Washington, DC

November 10, 2017

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 ...

November 9, 2017, Webinar

November 7, 2017, Covington Alert

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.

November 6, 2017, Covington Alert

China has recently announced several initiatives to reform its regulation of drugs and medical devices that could have a significant impact on pharmaceutical and medical device companies doing business in China.

November 2, 2017, BioWorld MedTech

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 ...

November 1, 2017, The Litigation Daily

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 ...

November 2017, Journal of Medical Device Regulation

October 25, 2017, EP Vantage

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 ...

October 25, 2017, Covington Alert

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 ...

October 10, 2017, EurActiv

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 ...

October 10, 2017, Covington Alert

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.

October 6, 2017, The National Law Journal

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.

October 4, 2017

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 ...

October 3, 2017, Global Investigations Review

Global Investigations Review highlights Jennifer Saulino's return to Covington as a partner in its Litigation and Investigations practice. 

October 3, 2017, Law360

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. ...

September 29, 2017, Regulatory Focus

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. ...

September 20, 2017, Covington Alert

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.

September 20, 2017, Covington Alert

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 ...

September 8, 2017, Covington Alert

As part of the Trump Administration’s move towards regulatory efficiency, FDA announced yesterday and published today in the Federal Register, the opportunity for public input on the Administration’s comprehensive review of its regulations.

August 23, 2017, Strategic Risk

August 14, 2017, GCR

August 10, 2017

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 ...

July 21, 2017, CQ Quarterly

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 ...

July 14, 2017, Pharmafile

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 ...

July 11, 2017, Medtech Insight

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 ...

July 6, 2017, The Recorder

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 ...

July 6, 2017, Daily Journal

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 ...

July 6, 2017, Law360

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], ...

July 2017, Journal of Medical Device Regulation

June 28, 2017, Covington Alert

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 ...

June 16, 2017, Medtech Insight

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 ...

June 6, 2017, Covington Alert

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 ...

June 1, 2017, MLex

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 ...

May 25, 2017, ACI Food Law & Regulation Forum

May 24, 2017, ACI Food Law & Regulation Forum

May 23, 2017, 2017 Protein Trends & Technology Seminar

May 23, 2017, Covington Alert

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 ...

May 11, 2017, PaRR

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 ...

May 9, 2017, MedTech Insight

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, ...

April 7, 2017, Covington Alert

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 ...

March 30, 2017, Law360

March 2017

February 28, 2017, Covington Alert

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.

February 19, 2017, Financial Times

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 ...

February 10, 2017, Law360

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 ...

February 1, 2017, 21st Century Cures Act Webinar Series

January 30, 2017

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 ...

January 25, 2017, 21st Century Cures Act Webinar Series

January 23, 2017, Covington Alert

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.

January 23, 2017, Covington Alert

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 ...

January 19, 2017, The Pink Sheet

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 ...

January 18, 2017, 21st Century Cures Act Webinar Series

January 17, 2017, Covington Alert

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 ...

January 16, 2017, Medtech Insight

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 ...

January 16, 2017, International Devices & Diagnostics Monitor

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 ...

January 13, 2017, Medtech Insight

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.

January 11, 2017, The Pink Sheet

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 ...

January 10, 2017, The Pink Sheet

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 ...

January 9, 2017, Covington Alert

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 ...

January 5, 2017, Covington Alert

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 ...

January 5, 2017, 21st Century Cures Act Webinar Series

January 3, 2017

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. ...

December 22, 2016, Covington Alert

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 ...

December 20, 2016, Law360

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 ...

December 7, 2016, Covington Alert

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 ...

December 6, 2016, Covington Alert

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, ...

December 5, 2016, Law Society Gazette

November 16, 2016, Health Law News and Commentary

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 ...

November 14, 2016, Regulatory Affairs Professionals Society

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 ...

November 14, 2016, Covington Alert

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 ...

November 11, 2016, FDA Week

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, ...

November 11, 2016, Drug Industry Daily

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.

November 4, 2016, FDA Week

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 ...

November 4, 2016, EU Food Law

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 ...

November 4, 2016, FDAnews

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 ...

November 3, 2016, The Pink Sheet

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 ...

November 3, 2016, FDLI Introduction to Medical Device Law and Regulation Course

November 2, 2016, Covington Alert

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 ...

October 28, 2016, FDA Week

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 ...

October 21, 2016

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 ...

October 17, 2016, Law360

October 13, 2016, Covington Alert

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 ...

October 6, 2016, EP Vantage

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.”

October 2016, Bio-Science Law Review

September 29, 2016, Inspection Insider

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’ ...

September 27, 2016, Covington Alert

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” ...

September 22, 2016

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 ...

September 21, 2016, Covington Alert

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 ...

September 16, 2016, Food Chemical News

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. 

September 16, 2016, Covington Alert

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).

September 12, 2016, International Devices & Diagnostics Monitor

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 ...

September 9, 2016, Law360

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 ...

September 7, 2016, Covington Alert

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 ...

September 1, 2016, The Recorder

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, ...

August 31, 2016

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 ...

August 26, 2016, Nutritional Outlook

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 ...

August 26, 2016, Covington Alert

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 ...

August 26, 2016, Covington Alert

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 ...

August 25, 2016

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 ...

August 24, 2016, Law360

August 18, 2016, Covington Alert

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 ...

August 17, 2016, Covington Alert

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 ...

August 15, 2016, Covington Alert

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) ...

August 5, 2016, FDA Week

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 ...

July 28, 2016, Food Dive

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, ...

July 18, 2016, Covington Alert

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 ...

July 15, 2016, Covington Alert

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 ...

July 14, 2016, Bloomberg BNA

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. ...

July 11, 2016, Covington Alert

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 ...

June 30, 2016, Covington Alert

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 ...

June 28, 2016, Bloomberg

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 ...

June 27, 2016, The Legal Intelligencer

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 ...

June 27, 2016, Covington Alert

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 ...

June 24, 2016, Politico

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 ...

June 22, 2016, Webinar

June 13-14, 2016, FDLI/CDRH In-House Training: Introduction to Medical Device Law and Regulation Workshop

June 2, 2016, Covington Alert

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 ...

May 31, 2016, Covington Alert

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 ...

May 25, 2016, Law360

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 ...

May 23, 2016, Covington Alert

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, ...

May 16, 2016, Covington Alert

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 ...

May 12, 2016, Webinar

May 11, 2016, This article was published in Scrip Regulatory Affairs

May 8, 2016, Financial Times

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 ...

April 25, 2016, International Devices & Diagnostics Monitor

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 ...

April 20, 2016, Covington Alert

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 ...

April 14, 2016, Covington Alert

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 ...

April 7, 2016, Covington Alert

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 ...

April 1, 2016, Covington Alert

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 ...

March 31, 2016, Update

March 31, 2016, FDLI Hot Topics in Medical Device Law Conference

March 24, 2016

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 ...

March 22, 2016, Covington Alert

February 26, 2016, Nutra Ingredients

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 ...

February 17, 2016, Politico

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 ...

February 2016, European Journal on Risk Regulation

January/February 2016, Update

January 2016, Covington Alert

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 ...

December 2, 2015, Webinar

November 25, 2015, Covington Alert

November 23, 2015

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 ...

November 17, 2015, Covington Alert

November 17, 2015, Covington Alert

November 17, 2015, Covington Alert

November 16, 2015, Law360

November 9, 2015

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 ...

October 29, 2015, Covington Alert

September 18, 2015, Covington Alert

September 17, 2015, Covington Alert

September 16, 2015, FDLI/CDRH In-House Training: Introduction to Medical Device Law and Regulation Workshop

September 14, 2015, Covington Alert

August 11, 2015, Covington Alert

August 7, 2015, Covington Alert

August 2015, JUVE

Quoting Adem Koyuncu on anti-corruption issues in the pharma sector.

August 2015, An Extract from The European Antitrust Review 2016

July 29, 2015

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 ...

July 28, 2015, Covington Alert

7/27/2015, Covington Alert

July 10, 2015, Covington Alert

6/18/2015, Covington Alert

June 17, 2015, The New York Times

The firm is mentioned in this article regarding it's representation of Allergan in its $2.1 billion acquisition of Kythera Biopharmaceuticals. 

June 17, 2015, Life Sciences Essentials Webinar Series

June 8, 2015, Covington Alert

June 3, 2015, Covington Alert

May 29, 2015

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 ...

May 20, 2015, Covington E-Alert

April 29, 2015, Covington E-Alert

April 21, 2015, InsideMedicalDevices Blog

April 20, 2015

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 ...

April 10, 2015, Am Law's The Litigation Daily

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 ...

April 1, 2015, Life Sciences Essentials Webinar Series

March 11, 2015, Law360

February 23, 2015, Covington E-Alert

February 13, 2015, Covington E-Alert

February 4, 2015, Covington E-Alert

January 27, 2015, Scrip Regulatory Affairs

January 26, 2015, Covington E-Alert

January 23, 2015, Covington E-Alert

January 12, 2015, InsideMedicalDevices Blog

2015, Webinar, 24th Annual EU Pharmaceutical Forum

December 8, 2014

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 ...

December 4, 2014, Covington E-Alert

December 1, 2014, Covington E-Alert

November 14, 2014, Law360

November 12, 2014, Covington E-Alert

November 6, 2014, Life Sciences Essentials Series Webinar

November 4, 2014, Covington E-Alert

November 3, 2014, Law360

October 16, 2014, Life Sciences Essentials Series Webinar

September 23, 2014, Covington E-Alert

September 23, 2014, Covington E-Alert

September 23, 2014, Covington E-Alert

September 23, 2014, Covington E-Alert

September 9, 2014, Covington E-Alert

August 21, 2014, Covington E-Alert

August 21, 2014, InsideMedicalDevices Blog

August 18, 2014, Covington E-Alert

August 5, 2014

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 ...

July 29, 2014, Forbes

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 ...

July 18, 2014, Covington E-Alert

July 17, 2014, Law360

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 ...

July 2, 2014, Covington E-Alert

July 1, 2014, Covington E-Alert

July 1, 2014, InsideMedicalDevices Blog

June 25, 2014, Forbes

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 ...

June 19, 2014, Covington E-Alert

June 4, 2014, Covington E-Alert

May 22, 2014, InsideMedicalDevices Blog

April 30, 2014, Covington E-Alert

April 30, 2014, Covington E-Alert

April 28, 2014, Covington E-Alert

April 25, 2014, Covington E-Alert

April 25, 2014, Covington E-Alert

April 20, 2014, Forbes

Covington's John Balzano writes about a recent announcement by the China FDA and the Ministry of Public Security that China is creating a special police unit for food and drug law violations.

April 16, 2014, Law360

April 9, 2014, Covington E-Alert

April 1, 2014, Covington E-Alert

March 2014, Pharma Recht

March 24, 2014, Forbes

John Balzano, special counsel in Covington's food and drug practice group, writes about the regulatory enforcement of illegal sales of recycled or expired food in Chinese village markets in his latest blog post for Forbes.

March 6, 2014, Covington E-Alert

March 4, 2014

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 ...

March 4, 2014, Covington E-Alert

March 3, 2014, Covington E-Alert

March 2014, The Life Sciences Law Review

February 28, 2014, Covington E-Alert

February 21, 2014, Covington E-Alert

February 5, 2014, Covington E-Alert

January 29, 2014, Covington E-Alert

January 22, 2014, Covington E-Alert

January 16, 2014, Covington E-Alert

January 16, 2014, Covington E-Alert

January 10, 2014, Covington E-Alert

December 31, 2013, Covington E-Alert

December 24, 2013, Covington E-Alert

December 2, 2013, Covington E-Alert

December 2, 2013, Covington E-Alert

November 20, 2013, Covington E-Alert

November 15, 2013, Law360

November 12, 2013, Covington E-Alert

November 8, 2013, Covington E-Alert

November 7, 2013, Covington E-Alert

October 31, 2013, Covington E-Alert

October 22, 2013, Covington E-Alert

October 1, 2013, Covington E-Alert

9/27/2013

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 ...

September 26, 2013, Covington E-Alert

September 25, 2013, Covington E-Alert

September 24, 2013, Covington E-Alert

September 6, 2013, Law360

August 28, 2013, Covington E-Alert

August 19, 2013, Covington E-Alert

August 16, 2013, Covington E-Alert

August 12, 2013, Covington E-Alert

August 9, 2013, Covington E-Alert

August 8, 2013, Covington E-Alert

August 2013, Journal of Medical Device Regulation

July 31, 2013, Covington E-Alert

July 30, 2013, Covington E-Alert

July 30, 2013, Covington E-Alert

July 26, 2013, Covington E-Alert

July 19, 2013, Covington E-Alert

June 27, 2013, Covington E-Alert

June 25, 2013, Covington E-Alert

June 20, 2013

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 ...

June 13, 2013, InsideMedicalDevices Blog

May/June 2013, Update (Reprinted with Permission of FDLI)

May 30, 2013, Covington E-Alert

May 24, 2013, Covington E-Alert

May 17, 2013, Covington E-Alert

April 26, 2013, Covington E-Alert

April 15, 2013, Covington E-Alert

April 9, 2013, Covington E-Alert

April 2013, The Life Sciences Law Review

March 28, 2013, Covington E-Alert

March 25, 2013, Covington E-Alert

March 18, 2013, Covington E-Alert

Winter/Spring 2013, The SciTech Lawyer

February 27, 2013, Covington E-Alert

February 13, 2013, Covington E-Alert

February 1, 2013, Covington E-Alert

January 28, 2013, Covington E-Alert

January 10, 2013, Covington E-Alert

January 10, 2013, Covington E-Alert

January 8, 2013

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 ...

January 7, 2013

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 ...

2013, Food and Drug Law Journal (re-printed with permission of The Food and Drug Law Institute)

2013

December 28, 2012, Covington E-Alert

December 7, 2012, Covington E-Alert

December 3, 2012, Covington E-Alert

December 2012, GxP Lifeline

11/7/2012

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 ...

November 2012, Regulatory Focus

October/November 2012, Food Safety Magazine

October 31, 2012, Covington E-Alert

October 22, 2012, Covington E-Alert

October 4, 2012, Covington E-Alert

October 3, 2012, Covington E-Alert

October 1, 2012

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 ...

September 28, 2012, Covington E-Alert

September 27, 2012, Covington E-Alert

September 26, 2012, Covington E-Alert

September 17, 2012, Covington Advisory

September 13, 2012

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 ...

September 6, 2012

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 ...

September 2012, Covington E-Alert

September 2012, European Pharmaceutical Contractor

August 31, 2012, Covington E-Alert

August 27, 2012

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 ...

August 16, 2012, Covington E-Alert

August 14, 2012

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 ...

August 10, 2012, Covington E-Alert

August 2012, Journal of Medical Device Regulation

August 1, 2012, Covington E-Alert

July 26, 2012, Covington E-Alert

July 16, 2012, Covington Advisory

June 29, 2012, Covington E-Alert

June 28, 2012, Covington E-Alert

June 22, 2012

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 ...

June 14, 2012, Covington E-Alert

June 11, 2012, Covington E-Alert

June 7, 2012, Covington Advisory

June 2012, Scrip Regulatory Affairs

May 29, 2012, Covington E-Alert

May 25, 2012, Covington E-Alert

May 24, 2012

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 ...

May 8, 2012, Covington E-Alert

May 7, 2012, Covington E-Alert

May 2, 2012

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 ...

April 30, 2012, Covington E-Alert

April 24, 2012, Covington E-Alert

April 23, 2012

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 ...

March 23, 2012, Covington E-Alert

March 22, 2012, Covington E-Alert

March 12, 2012

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 ...

March 1, 2012, Covington E-Alert

February 29, 2012, Covington E-Alert

February 13, 2012, Covington E-Alert

February 7, 2012, Covington E-Alert

February 7, 2012, Covington E-Alert

January 19, 2012, Covington E-Alert

January 9, 2012, Covington E-Alert

January 3, 2012, Covington E-Alert

2012, PLC Life Sciences Handbook 2012

2012, Life Sciences Handbook

December 30, 2011, Covington E-Alert

December 23, 2011, Covington E-Alert

November 30, 2011

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 ...

November 10, 2011

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 ...

November 9, 2011, Educational Program for Chinese SFDA Officials, New Haven, CT

November 1, 2011

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. ...

November 2011, Food Safety Magazine

November 2011, Journal of Medical Device Regulation

October 24, 2011, Covington E-Alert

October 5, 2011

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, ...

October 3, 2011

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 ...

October 2011, Food Manufacturing

September 7, 2011

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: ...

September 1, 2011, Covington E-Alert

August 4, 2011, Covington E-Alert

July 22, 2011

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, ...

July 6, 2011, Covington E-Alert

June 22, 2011, Covington E-Alert

June 22, 2011, Covington E-Alert

June 13, 2011, Covington E-Alert

June 10, 2011

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 ...

May 25, 2011, Covington E-Alert

April 29, 2011, Covington E-Alert

April 15, 2011, Covington E-Alert

April 6, 2011, Covington E-Alert

April 4, 2011, Covington E-Alert

March 9, 2011, Covington E-Alert

February 22, 2011

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 ...

February 2, 2011, Covington E-Alert

January 25, 2011, Covington E-Alert

1/6/2011

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, ...

January 3, 2011, Covington E-Alert

2011, Life Sciences Handbook 2011

2011, Life Sciences Handbook 2011

2011, Life Sciences Handbook

December 22, 2010, Covington E-Alert

December 14, 2010, Covington E-Alert

December 13, 2010, Covington E-Alert

December 9, 2010, Covington E-Alert

December 2010, Covington E-Alert

November 10, 2010, Covington E-Alert

November 4, 2010, Covington E-Alert

November 4, 2010, Covington E-Alert

November 2010, Journal of Medical Device Regulation

October 29, 2010, Covington E-Alert

October 25, 2010

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 ...

October 25, 2010, Covington E-Alert

October 14, 2010, Covington E-Alert

October 12, 2010

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 ...

September 23, 2010, Covington E-Alert

September 22, 2010

September 17, 2010

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 ...

September 7, 2010, Covington E-Alert

August 25, 2010, Covington E-Alert

August 18, 2010, Covington E-Alert

August 10, 2010, Covington E-Alert

August 9, 2010, Covington E-Alert

August 6, 2010

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: ...

August 3, 2010, Covington E-Alert

August 2010, Journal of Medical Device Regulation

July 6, 2010

June 25, 2010

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 & ...

June 21, 2010, Covington E-Alert

June 16, 2010

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 ...

June 16, 2010, Covington E-Alert

June 10, 2010, Covington E-Alert

June 3, 2010, Covington E-Alert

May 25, 2010, Covington E-Alert

May 13, 2010, Covington E-Alert

5/6/2010

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 ...

April 29, 2010, Covington E-Alert

April 29, 2010, Covington E-Alert

April 28, 2010, Covington E-Alert

April 22, 2010, Covington E-Alert

April 12, 2010, Covington E-Alert

April 12, 2010, Covington E-Alert

April 5, 2010, Covington E-Alert

April 2010, Covington E-Alert

April 2010, Covington E-Alert

April 2010, Covington E-Alert

April 2010, Covington E-Alert

April 2010, Covington E-Alert

March 23, 2010, Covington E-Alert

March 10, 2010, Covington E-Alert

March 5, 2010, Covington E-Alert

March 4, 2010, Covington E-Alert

February 22, 2010

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 ...

Jan 28th, 2010, Covington E-Alert

January 15, 2010

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 ...

January 12, 2010, Covington E-Alert

2009/10, PLC Life Sciences Handbook 2009/10

2009/10, Life Sciences Handbook

2009/10, PLC Life Sciences Handbook 2009/10

2010, In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI )

2010, In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI )

December 16, 2009, Covington E-Alert

November 30, 2009, Covington E-Alert

11/23/2009

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 ...

November 20, 2009, Covington E-Alert

November 9, 2009, Covington E-Alert

October 30, 2009, Covington E-Alert

10/1/2009

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 ...

September 15, 2009, Covington E-Alert

September 15, 2009, Covington E-Alert

September/October 2009, RAJ Devices

August 31, 2009, Covington E-Alert

August 26, 2009, Covington E-Alert

August 7, 2009

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: ...

July 31, 2009, Covington E-Alert

July 27, 2009, Covington E-Alert

7/22/2009

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 ...

July 9, 2009, Covington E-Alert

June 29, 2009, Covington E-Alert

June 24, 2009, Covington E-Alert

June 19, 2009, Covington E-Alert

June 12, 2009

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 ...

5/19/2009

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 ...

5/14/2009

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 ...

April 14, 2009, Covington E-Alert

April 13, 2009, Covington E-Alert

April 2, 2009, Covington E-Alert

March 30, 2009, Covington E-Alert

March 30, 2009, Covington E-Alert

March 25, 2009, Covington E-Alert

March 20, 2009, Covington E-Alert

March 20, 2009, SCRIP

March 17, 2009, Covington E-Alert

March 9, 2009, Covington E-Alert

March 9, 2009, Covington E-Alert

March 6, 2009, Covington E-Alert

March 6, 2009, Covington E-Alert

February 23, 2009, Covington E-Alert

February 17, 2009, Covington E-Alert

February 9, 2009, Covington E-Alert

February 5, 2009, Covington E-Alert

February 4, 2009, Covington E-Alert

February 3, 2009, Covington E-Alert

February 2, 2009, Covington Advisory

January 28, 2009, Covington E-Alert

January 26, 2009, Covington E-Alert

January 21, 2009, Covington E-Alert

January 16, 2009, Covington E-Alert

January 15, 2009, Covington E-Alert

January 9, 2009, Covington E-Alert

January 7, 2009, Covington E-Alert

January/February 2009, Update

December 23, 2008, Covington E-Alert

December 23, 2008, Covington E-Alert

December 16, 2008, Covington E-Alert

December 15, 2008, Covington E-Alert

12/11/2008

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 ...

December 10, 2008, Covington E-Alert

12/2/2008

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 ...

December 1, 2008, Covington E-Alert

2008, chapter 7 in FDLI’s 2008 Food and Drug Law and Regulation

November 18, 2008, Covington E-Alert

November 18, 2008, Covington E-Alert

November 14, 2008, Covington E-Alert

November 8, 2008, Journal of Medical Device Regulation, Vol. 5(4)

November 7, 2008, Covington E-Alert

October 28, 2008, Covington E-Alert

10/1/2008

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 ...

October 2008, EURALex

September 29, 2008

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: ...

September 17, 2008, Covington E-Alert

September 2008, Covington E-Alert

August 11, 2008, Covington E-Alert

August 8, 2008, Covington E-Alert

August 2008, Food and Drug Law Journal (With permission from FDLI)

August 1, 2008, Covington E-Alert

July 29, 2008, Covington E-Alert

July 11, 2008, Covington E-Alert

June 16, 2008

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 ...

June 9, 2008, Covington E-Alert

May 27, 2008, Covington E-Alert

April 25, 2008, Covington E-Alert

April 24, 2008, Covington E-Alert

4/3/2008

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 ...

April 2008, Covington E-Alert

March 2008, EURALex

February 19, 2008, Covington E-Alert

February 12, 2008, Covington E-Alert

January 30, 2008, Covington E-Alert

January 18, 2008, Covington E-Alert

January 3, 2008, Covington E-Alert

January 2, 2008, Covington E-Alert

2008, Food and Drug Law Journal

December 26, 2007, Covington E-Alert

December 7, 2007

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 ...

11/30/2007

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 ...

November 28, 2007, Covington E-Alert

November 26, 2007, Covington E-Alert

November 6, 2007, Covington E-Alert

November 6, 2007, Covington E-Alert

October 2, 2007, Covington E-Alert

10/1/2007

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 ...

September 21, 2007, Covington E-Alert

September 21, 2007, Covington E-Alert

September 6, 2007

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 ...

September 4, 2007, Covington E-Alert

September 3, 2007, Covington E-Alert

August 6, 2007, Covington E-Alert

July 19, 2007, Covington E-Alert

July 17, 2007, Health Law 360

June 29, 2007, Covington E-Alert

June 18, 2007

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 ...

June 8, 2007, Covington E-Alert

May 31, 2007, Covington E-Alert

May 17, 2007, Covington E-Alert

May 3, 2007, Covington E-Alert

May 2, 2007, Covington E-Alert