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- Home
- Practices and Industries
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- Food, Drug, and Device
- Pharma and Biotech
Covington is the recognized leader in representing clients on FDA and related regulatory matters involving human pharmaceuticals and biotechnology products in the US, Europe, and China. Our attorneys, including several alumni of the FDA and other key regulatory bodies, advise the world’s leading biopharmaceutical manufacturers, emerging companies, and the principal industry trade associations, including PhRMA, on all aspects of human pharmaceutical and biologics regulation – from research and development to commercialization and end-of-lifecycle planning.
As a result of our long and deep work in the area, Covington lawyers have extensive knowledge of the governing laws and regulations, broad-based practical experience with their application, and an intimate knowledge of government regulators and enforcement authorities. We have represented clients in hearings on drug approval withdrawals, dispute resolution proceedings, rulemaking proceedings, and enforcement actions, as well as in challenges to FDA decisions regarding product exclusivities.
We regularly advise manufacturers, as well as distributors and other companies, on the legal requirements and First Amendment rights for promoting drugs, including requirements of the Prescription Drug Marketing Act (PDMA) and matters involving the FDA Office of Prescription Drug Promotion (OPDP). We have extensive experience in review of labeling and advertising claims, FTC regulatory and enforcement proceedings, Lanham Act false advertising cases, and self-regulatory advertising proceedings before the National Advertising Division (NAD) of the Council of Better Business Bureau.
Our lawyers actively advise clients on manufacturing, product quality, and FDA inspection matters. The firm has been involved in nearly all of the major FDA and Department of Justice pharmaceutical GMP enforcement actions from the landmark Warner-Lambert consent decree of 1993 forward, representing both company and individual defendants. We have a high degree of credibility on these issues with key officials from the FDA and the Office of Consumer Litigation of the Department of Justice. We also have strong working relationships with the leading GMP and QSR consultants. Our knowledge of the evolution of FDA's approach to product quality provides a strong platform from which to advise clients on technical GMP/QSR requirements, broader quality systems issues, recalls, field alerts, and FDA inspections.
Covington lawyers have been extensively involved in every aspect of the Hatch-Waxman legislation since its passage in 1984, before FDA, in the courts, and before Congress. We advise clients on strategies relating to patent listing, generic approval standards, non-patent (regulatory) exclusivity, pediatric exclusivity, settlement of patent litigation, authorized generics, and 180-day generic exclusivity. Our team has extensive experience with citizen petitions, pursuing formal and informal advocacy at FDA, and engaging in targeted litigation to maximize product lifecycles. We have represented PhRMA on all issues relating to the Hatch Waxman legislation, including in rulemakings, on amicus briefs, and with respect to legislative proposals. We were deeply involved in the rulemaking and legislative changes in 2003, and we are routinely involved—on behalf of PhRMA and individual biopharmaceutical companies—in legislative proposals in this space.
Our attorneys were also deeply engaged in the policy discussions and legislative negotiations that culminated in enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), on behalf of a large coalition of biotechnology innovators, many individual biopharmaceutical companies, and PhRMA. Since the law’s enactment in March 2010, we have been heavily involved in implementation on behalf of the research-based industry, coordinating advocacy in the United States with advocacy on biosimilar issues worldwide, and assisting numerous companies with development and execution of lifecycle defense strategies for key products. Our work for individual companies in this space includes advocacy at FDA on scientific, regulatory, and legal issues specific to their products (for example, on exclusivity eligibility, the scientific standards governing biosimilar applications, and policy issues connected to naming and labeling). Covington assembles integrated teams of regulatory, patent advisory, and patent litigation lawyers — all steeped in the issues presented by biosimilars — in order to craft coordinated, global patent and regulatory defense strategies.
FDCA Amendments Legislation
Representation of industry stakeholders in negotiations and legislative process leading to every major amendment to the FDCA since its enactment in 1938.
Biopharmaceutical Legislation Representation
Representation of coalition of innovative biopharmaceutical manufacturers during the multi-year process that led to enactment of the Biologics Price Competition and Innovation Act of 2010 (BPCIA). Played a similar role for the pharmaceutical industry prior to enactment of the Hatch-Waxman amendments of 1984. Currently advising members of the pharmaceutical industry on FDA regulatory aspects of 21st Century Cures Act and the Senate’s Innovation for Healthier Americans initiative.
GMP Consent Decree Negotiations
Representation of companies and individuals in negotiation of GMP consent decrees involving drugs, biologics, devices, and blood products, including significant consent decree matters for Schering Plough, Genzyme and one of the largest manufacturers of OTC drugs in the U.S.
China Biopharmaceutical Regulatory and Legal Strategy
Counseling leading multinational biopharmaceutical company in doing business in China, including setting and executing on the regulatory and legal strategies for engaging in drug R&D, manufacturing, and sales and marketing.
China Online Drug Information Regulation
Advise multinational company on regulation of online information on drugs, devices, and food products in China.
King Pharmaceuticals Acquisition by Pfizer
Representation of King Pharmaceuticals in its $3.6 billion acquisition by Pfizer.
Kos Pharmaceuticals Medicare Part D coverage
Assisted Kos Pharmaceuticals in obtaining Medicare Part D coverage for its previously excluded product.
AbbVie/Calico $1.5B collaboration
Assisting AbbVie in structuring and negotiating a novel collaboration with the Google-backed life sciences start-up company Calico to form a $1.5 billion to fund a program focused on aging and age-related diseases.
NICE Challenge for Irish Biopharmaceutical Company
Advised the wholly owned Irish subsidiary of a major U.S. biopharmaceutical company on a negative recommendation from the UK's NHS reimbursement from the National Institute of Health and Care Excellence (NICE) on a treatment for obesity and an appeal against it.
Meretek Diagnostics ITC Section 337 Investigation
Representation of Meretek Diagnostics in the ITC Section 337 Investigation: Breath Test Systems for the Detection of Gastrointestinal Disorders, USITC Inv. No. 337-TA-495 (Complainant).
Nidek ITC Section 337 Investigation
Representation of Nidek in the ITC Section 337 Investigation: Excimer Laser Systems for Vision Correction Surgery and Components Thereof and Methods for Performing Such Surgery, Inv. No. 337-TA- 419 (Respondent).
FDCA, FTC Act, and Lanham Act Compliance for life sciences companies
Advising distributors of prescription drugs and medical devices concerning compliance with the Food, Drug, and Cosmetic Act, FTC Act, and Lanham Act advertising standards.
Animal Drug Regulation
Advising veterinary pharma companies on issues relating to abbreviated paths to drug approval and issues related to the Center for Veterinary Medicine’s new positioning on growth promotion claims for antibiotics used in human medicine.
Anti-kickback safe harbors
Developed for a major pharmaceutical client proposals for new potential safe harbors under the federal anti-kickback statute for potential submission to the OIG.
AstraZeneca/Bristol-Myers Squibb diabetes alliance
Representation of AstraZeneca in its strategic diabetes alliance with Bristol-Myers Squibb, including with respect to collaboration arrangements for the development and commercialization of Amylin Pharmaceuticals’ portfolio of diabetes products following BMS’s acquisition of Amylin in a deal valued at $7 billion (approximately half the cost of which was borne by AstraZeneca).
China licensing and collaboration
Advising a leading multinational pharmaceutical company on its agreement with a Nasdaq-listed drug manufacturer to develop and market its linaclotide capsule in China.
China licensing and joint venture
Advising a U.S. biotech company on its sino-foreign joint venture with a Chinese life sciences company to focus on RNAi-based drug discovery, and related license agreement.
China life sciences transactional
Advising a leading multinational pharmaceutical company on the acquisition of diabetes drug assets in China and the transfer of related employees from a multinational drug company.
China life sciences transactional
Representing a leading U.S. pharmaceutical company to set up a joint venture in China with a Chinese biotech company to research, develop and commercialize a late-stage clinical product for the Asia market.
China pharma bribery investigation
Representation of a major pharmaceutical company in its response to a Chinese government commercial bribery investigation in China.
China Regulatory and Compliance
Conducting internal investigation on behalf of a multinational pharmaceutical company into whistleblower allegations of corruption at its Chinese subsidiary.
False Claims Act litigation and appellate defense
Successful defense of Pfizer in both the district court and the court of appeals on a series of claims by a relator concerning Genotropin.
Hatch-Waxman settlement investigation and class action
AstraZeneca in an FTC investigation and private antitrust class action litigation concerning settlements of Hatch-Waxman patent litigation involving Nexium.
Healthcare business corporate structure and governance
Advice to a major pharmaceutical in establishing a healthcare business in the UK, including strategic advice on corporate structure and governance issues and compliance with Vare Quality Commission standards.
In re K-Dur Antitrust Litigation
Representing Schering-Plough (now Merck) in multi-district class action litigation challenging so-called reverse payment settlements of pharmaceutical patent litigation. Obtained denial of certification of indirect purchaser class, after which indirect purchasers voluntarily dismissed their case. The team previously defeated the FTC at trial in an action on the same facts, and will now have the opportunity to resolve the direct purchaser portion of the case under a recent Supreme Court decision.
Medicaid coverage for dropped products
Assisted several pharmaceutical manufacturers in reinstating Medicaid coverage for products dropped from the program by the Centers for Medicare & Medicaid Services (CMS).
Merck Merger with Schering-Plough
Representation of Merck in its $41 billion merger with Schering-Plough.
Off-label promotion and reporting investigations
Representation of GlaxoSmithKline in global settlement of three investigations relating to off-label promotion, safety reporting and price reporting.
Prescription drug user privacy litigation
Advised a large pharmaceutical company in connection with litigation involving the alleged infringement of patient privacy by a pharmacy chain that collects personal information about prescription drug users.
Reversal of FDA denial of period of exclusivity
Representation of Amarin in the first known reversal of an FDA denial of a 5-year period of new chemical entity (NCE) exclusivity since the enactment of the Hatch-Waxman Amendments in 1984, in connection with Amarin’s Vascepa drug for lowering triglyceride levels.
Specialty Pharma cross-border licensing agreement
Salix Pharmaceuticals in its licensing agreement with Alfa Wasserman S.p.A., by which Salix has licensed rights in the United States and Canada to an extended intestinal release (EIR) formulation of rifaximin.
Advice to Numerous Life Sciences Companies on Regulatory Compliance and Infrastructure
Advice to numerous pharmaceutical and medical technology companies on compliance with with pharmaceutical and medical device regulations. For pharmaceutical companies, this has included compliance with manufacturing and supply chain rules, pharmacovigilance, and other “GxP” requirements. We have advised device manufacturers on borderline, classification, conformity assessment and other quality system requirements, including in the digital health space. In both industries, we have advised extensively on the impact of, and preparations for Brexit.
Case Challenging a Negative Reimbursement Decision before the Irish High Court
Advised U.S. pharmaceutical company PTC Therapeutics on the first ever challenge on a negative reimbursement decision by the Health Executive Ireland relating to ultra-orphan drug, Translarna.
Litigation risk counseling
Conducting due diligence investigations and performing risk assessments to evaluate potential product or toxic tort liabilities associated with pharmaceutical and medical device companies bringing products to market.
February 16, 2021
FRANKFURT—WirtschaftsWoche, Germany’s leading business weekly news magazine, has named Covington as one of the “Top Law Firms” for Pharma & Medical Devices law and Dr. Dr. Adem Koyuncu a “Top Lawyer” in Germany. Dr. Dr. Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm's ...
January 2021, Covington Guide
The EU-UK Trade and Cooperation Agreement (EUTCA) reached on December 24th is a wide-ranging and complex agreement. Our Brexit Task Force offers these "bite-sized" recordings to give a snapshot of what you need to know in each area. Though the EUTCA provides the overall architecture of the future relationship in a number of areas, much of the detail must still ...
Gerald Masoudi Rejoins Covington
October 1, 2020
WASHINGTON—Gerald Masoudi, former General Counsel of Celgene Corporation and then JUUL Labs, has rejoined Covington’s Food, Drug, and Device Practice Group in Washington as a partner. Mr. Masoudi has more than 25 years of broad experience in the life sciences industry. He served as Chief Counsel of the U.S. Food and Drug Administration from 2007 to 2009. He ...
October 1, 2020, NPR
Julie Dohm is quoted in NPR regarding the use of unproven COVID-19 treatments and compounded drugs. Regarding compounded drugs, Ms. Dohm says, “They are subject to a lower quality standard, and so it's very important that they really only be used when medically necessary.”
July 24, 2020, Covington Alert
On July 24, 2020, the United States Department of Agriculture’s Agricultural Marketing Service (“AMS”) published proposed updates to its list of bioengineered (“BE”) foods. Under the National Bioengineered Food Disclosure Standard (“NBFDS”), manufacturers, importers, and certain retailers must make a BE disclosure for foods on this list or foods containing ...
July 22, 2020, Covington Alert
Yesterday, the Food and Drug Administration (FDA) issued draft guidance describing the agency’s thinking on topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. While the draft guidance is limited to drug development and does not address other types of products, some of FDA’s thinking may ...
June 22, 2020, Covington Alert
Drug manufacturers have responded to the COVID-19 pandemic by adopting critical measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, they have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and ...
June 12, 2020, BioSpace
Wade Ackerman is quoted in BioSpace regarding the decentralization of clinical trials in the pharmaceutical industry. Mr. Ackerman says the “all hands on deck” approach to the pandemic by Congress and the FDA set the stage for clinical trial innovation. “It has set up a lot of conversations about where telehealth is, and where it will be six months from now,” he ...
June 9, 2020, STAT News
Julie Dohm is quoted in STAT News regarding the FDA’s temporary policy allowing smaller pharmacies to make certain drugs for treating COVID-19 without first receiving a patient’s prescription for the drug. The condition for this new policy is that the pharmacies sell the drugs to a hospital that can prove it could not source the drugs from elsewhere. Ms. Dohm ...
May 26, 2020, STAT News
Thomas Cosgrove is quoted in STAT News regarding the cost for U.S. pharmaceutical companies to produce drugs domestically. Mr. Cosgrove says, “What would it take the supply chain to come all the way back to the U.S.? It’s simple: It will take decades and billions.”
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 ...
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.
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 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
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 ...
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 ...
Sarah Cowlishaw Named to The Lawyer “Hot 100”
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.
CREATES Act Becomes Law
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 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 ...
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 ...
Former FDA Drug Regulatory Adviser Joins Covington in DC
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.”
Former FDA Official Joins 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 ...
The Brexit Headaches Keeping Partners Awake At Night
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.
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.
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.
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 – ...
July 13, 2018
WASHINGTON—Covington's patent litigators secured a significant win on behalf of Indivior, obtaining a preliminary injunction preventing Dr. Reddy's Laboratories from launching a generic version of Indivior's SUBOXONE® Sublingual Film used in treatment of opioid addiction. The court's decision recognizes that Indivior had shown a likelihood of success on the ...
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.
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 2018, Digital Health Legal
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.
Covington Lures Back FDA Drug Quality Leader
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 ...
Top 10 Game-Changing Litigator Moves in October
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 ...
European approvals face delay from agency move
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 ...
State Appellate Vets Team Up; Another Law Firm Merger; Inside Clyde's Insurance Practice Play
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 ...
Ex-FCPA unit supervisor joins Covington
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.
Former DOJ Prosecutor Rejoins Covington In Washington
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. ...
What Brexit means for drug regulation
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 ...
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 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, ...
May 5, 2017
LOS ANGELES—The California Life Sciences Association (CLSA) has named Covington partner Wade Ackerman to its board of directors. Founded in 2015, CLSA works closely with industry, government, academia and other stakeholders to shape public policy, drive business solutions, and grow California’s life sciences innovation ecosystem. CLSA serves biotechnology, ...
Life Sciences Group Of The Year: Covington & Burling
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 ...
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 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.
J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva's Slowed Growth, Merck's Keytruda Wins, Lilly's CDK4/6 Hopes And More
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 ...
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 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 ...
Positions Staked out on Impact of First Amendment on Manufacturer Communication on Off-label Uses
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 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 ...
Postmarking Issues
November 3, 2016, FDLI Introduction to Medical Device Law and Regulation Course
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).
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 ...
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 ...
Dealing with Adverse Events/Product Problems
June 13-14, 2016, FDLI/CDRH In-House Training: Introduction to Medical Device Law and Regulation Workshop
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 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 ...
Postmarket Issues And Strategies
March 31, 2016, FDLI Hot Topics in Medical Device Law Conference
Fate of EU drugs agency hangs in Brexit balance
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
Premarket Approvals (PMAs)
September 16, 2015, FDLI/CDRH In-House Training: Introduction to Medical Device Law and Regulation Workshop
Covington Represents Underwriters in Cidara IPO
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 ...
November 12, 2014, Covington E-Alert
February 28, 2014, Covington E-Alert
January 29, 2014, Covington E-Alert
January 22, 2014, Covington E-Alert
January 10, 2014, Covington E-Alert
December 31, 2013, Covington E-Alert
December 2, 2013, Covington E-Alert
December 2, 2013, Covington E-Alert
November 20, 2013, Covington E-Alert
November 12, 2013, Covington E-Alert
November 8, 2013, Covington E-Alert
October 1, 2013, Covington E-Alert
August 28, 2013, Covington E-Alert
August 12, 2013, Covington E-Alert
July 31, 2013, Covington E-Alert
June 27, 2013, Covington E-Alert
May 30, 2013, Covington E-Alert
April 15, 2013, Covington E-Alert
March 28, 2013, Covington E-Alert
March 18, 2013, Covington E-Alert
February 27, 2013, Covington E-Alert
January 28, 2013, Covington E-Alert
December 28, 2012, Covington E-Alert
December 7, 2012, Covington E-Alert
December 3, 2012, Covington E-Alert
October 31, 2012, Covington E-Alert
September 28, 2012, Covington E-Alert
August 31, 2012, Covington E-Alert
July 26, 2012, Covington E-Alert
June 11, 2012, Covington E-Alert
May 29, 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
April 30, 2012, Covington E-Alert
March 23, 2012, Covington E-Alert
March 22, 2012, Covington E-Alert
Covington to Open Seoul Office, Adds William H.Y. Park
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 ...
February 29, 2012, Covington E-Alert
February 7, 2012, Covington E-Alert
January 19, 2012, Covington E-Alert
September 1, 2011, Covington E-Alert
March 9, 2011, Covington E-Alert
December 14, 2010, Covington E-Alert
Health Care Reform: Federal Court Strikes Down Individual Coverage Mandate; Rest of Law Unaffected
December 13, 2010, Covington E-Alert
December 2010, Covington E-Alert
November 4, 2010, Covington E-Alert
November 4, 2010, Covington E-Alert
September 23, 2010, Covington E-Alert
August 9, 2010, Covington E-Alert
June 3, 2010, Covington E-Alert
April 29, 2010, Covington E-Alert
April 28, 2010, Covington E-Alert
April 2010, Covington E-Alert
April 2010, Covington E-Alert
Jan 28th, 2010, Covington E-Alert
November 30, 2009, Covington E-Alert
August 31, 2009, Covington E-Alert
August 26, 2009, Covington E-Alert
July 27, 2009, Covington E-Alert
June 29, 2009, Covington E-Alert
June 24, 2009, Covington E-Alert
April 14, 2009, Covington E-Alert
March 30, 2009, Covington E-Alert
March 25, 2009, Covington E-Alert
March 17, 2009, Covington E-Alert
March 9, 2009, Covington E-Alert
Comparative Effectiveness Research Provisions of the American Recovery and Reinvestment Act of 2009
March 6, 2009, Covington E-Alert
February 23, 2009, Covington E-Alert
February 17, 2009, Covington E-Alert
February 4, 2009, Covington E-Alert
January 15, 2009, Covington E-Alert
December 23, 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 1, 2008, Covington E-Alert
November 18, 2008, Covington E-Alert
August 11, 2008, Covington E-Alert
July 29, 2008, Covington E-Alert
July 11, 2008, Covington E-Alert
June 9, 2008, Covington E-Alert
February 19, 2008, Covington E-Alert
February 12, 2008, Covington E-Alert
January 30, 2008, Covington E-Alert
November 6, 2007, Covington E-Alert
FDA Releases Proposed Rule Amending The Final Monograph for Over-The-Counter Sunscreen Drug Products
September 4, 2007, Covington E-Alert
May 3, 2007, Covington E-Alert
February 6, 2007, Covington E-Alert
January 26, 2007, Covington E-Alert
January 19, 2007, Covington E-Alert
January 12, 2007, Covington E-Alert
December 18, 2006, Covington E-Alert
October 9, 2006, Covington E-Alert
September 27, 2006, Covington E-Alert
July 20, 2006
SAN FRANCISCO, July 20, 2006 - The San Francisco office of Covington & Burling LLP advised Procter & Gamble Pharmaceuticals, Inc., a division of The Procter & Gamble Company, in its strategic alliance with ARYx Therapeutics, a private drug discovery and development company based in Fremont, CA. Under the terms of the agreement, P&G will develop and ...
Covington Advises Emergent BioSolutions on Major R&D Collaboration Agreement with sanofi pasteur
June 6, 2006
LONDON, June 6, 2006 - Emergent BioSolutions, a privately-held biopharmaceutical company, has signed an agreement with sanofi pasteur, the vaccines business of the sanofi-aventis Group, to develop a critically-needed vaccine to prevent one of the world's deadliest childhood diseases, serogroup B meningitis. The Covington team that advised Emergent BioSolutions ...
June 5, 2006, Covington E-Alert
March 3, 2006, Covington E-Alert
January 27, 2006, Covington E-Alert
January 19, 2006
WASHINGTON, D.C., January 19, 2006 - Covington & Burling represented AstraZeneca AB in its recent global licensing and research collaboration agreement with Targacept Inc. Under the terms of the agreement, which is subject to the expiration or termination of the HSR (Hart Scott Rodino) clearance period in the US, AstraZeneca will obtain the global rights for ...
September 22, 2005
WASHINGTON, D.C., September 22, 2005 - Covington & Burling lawyers Peter Barton Hutt and Peter Safir were featured as two of Washington's top eleven Leading Food & Drug Lawyers in this week's edition of Legal Times. Covington was the only firm to have two lawyers recognized. In describing Mr. Hutt's reputation as a standout in the field, the Legal Times ...
December 2004, Covington E-Alert
December 2004, Covington E-Alert
December 2004, Covington E-Alert
September 17, 2004, Covington E-Alert
August 2004, Covington E-Alert
April 14, 2004, Covington E-Alert
December 11, 2003, Covington E-Alert
November 26, 2003, Covington E-Alert
March 28, 2002
March 28, 2002 - Washington, D.C.- In a historic ruling issued today, federal judge Emmet G. Sullivan overturned a federal law that prohibited District of Columbia residents from proposing, running, and voting on a ballot initiative to legalize marijuana for medical purposes. The decision resolved a First Amendment lawsuit against the federal government and the ...
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