Philip Katz

Philip Katz helps pharma/biotech companies successfully navigate FDA and related regulatory matters. He counsels them on compliance; helps anticipate and address regulatory issues in their day-to-day business operations and strategic planning; and advocates for them before the FDA, other agencies, and in court. His clients develop, manufacture, and distribute drugs and biologics, spanning from large public companies with extensive product portfolios to start-ups trying to bring their first product to market.

Phil is the former longtime head of the firm's Pharma/Biotech practice group, which has 25+ lawyers – many with years of experience at the FDA – who work collegially and in collaboration with our clients to help them achieve their business goals in a highly regulated environment in which good long-term relations with the FDA are essential. The excellence of the group is reflected in its Chambers ranking as a Band 1 D.C. Pharmaceutical/Medical Products Regulatory practice.

Phil and his team bring together a detailed and nuanced knowledge of the law and FDA precedents, an informed understanding of the client's business goals, and an experienced appreciation of the public policy implications to craft thoughtful, creative, and practical solutions. He and his team focus particularly on product development, approval, and lifecycle management; responding to agency enforcement activities; and counseling on business transactions. He has deep knowledge of the Hatch-Waxman Act, Orphan Drug Act, and Biosimilars Price Competition and Innovation Act.

Phil served as Chairman of the board of directors of the Food and Drug Law Institute (FDLI) and as a result of his dedicated work, he received the FDLI Distinguished Service and Leadership Award. Phil's leading role in the food and drug bar is reflected in his many recognitions, including Legal 500, Best Lawyers in America, Who's Who Legal, LMG Life Sciences "Regulatory Star," and Chambers.