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- Home
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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.
King Pharmaceuticals Acquisition by Pfizer
Representation of King Pharmaceuticals in its $3.6 billion acquisition by Pfizer.
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.
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).
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.
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.
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.
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 ...
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 ...
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, ...
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.
February 2018, Digital Health Legal
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 ...
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 ...
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 ...
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 ...
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 ...
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

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