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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.