Hogan Lovells US LLP

Pharmaceuticals and Biotechnology

Partner

Philip Katz helps pharmaceutical and biotech companies successfully navigate U.S. Food and Drug Administration (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 startups trying to bring their first product to market.

Phil heads the firm's Pharma/Biotech practice group, which has 30+ 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.

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.

English

J.D., Georgetown University Law Center, magna cum laude, Order of the Coif, 1992; B.A., University of Virginia, with distinction, 1981