Philip Katz > Hogan Lovells US LLP > Washington DC, United States > Lawyer Profile

Hogan Lovells US LLP
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON DC 20004
United States

Work Department

Pharmaceuticals and Biotechnology

Position

Partner

Career

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.

Languages

English

Education

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

Lawyer Rankings

United States > Industry focus > Healthcare: life sciences

Hogan Lovells US LLP ‘s national life sciences practice has a strong reputation for M&A, financing transactions and large-scale commercial deals. It also stands out for its dedicated regulatory offering and its experience in IP litigation and pharmaceutical and medical device product liability proceedings. Its Washington DC-based regulatory team was recently strengthened by the arrival of Jonathan Wasserman, former associate general counsel at Bristol Myers Squibb.  It is also highly commended for its Washington DC based FDA and healthcare regulatory team. Contacts in this space include Philip Katz, who leads the group’s pharmaceutical work; Randy Prebula, head of medical devices; Jonathan Kahan and David Fox, who focus on FDA matters; and Anishiya Abrol, a contact for commercial and licensing transactions. The service group is jointly led by Steve Abrams and Lynn Mehler in Philadelphia and Washington DC, respectively. Asher Rubin and Adriana Tibbitts joined Sidley Austin LLP in January 2021; Suzanne Filippi left for Morgan, Lewis & Bockius LLP in April, and Adam Golden left for Freshfields Bruckhaus Deringer LLP in May.