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

In addition to ‘outstanding expertise with small to mid-sized public biotech and pharma companies’ Hogan Lovells US LLP is also able to act for international pharmaceuticals companies. The team’s regulatory capacity is a key factor in this, advising on FDA clearances and post-approval compliance. IP is another area of expertise, primarily in transactions where the team provides diligence support in major capital markets and M&A matters and acts on IP litigation. It also has a strong product liability offering led by Baltimore-based Lauren Colton, which advises on medical devices and pharmaceuticals. The Washington DC office is led by biologics risk evaluation expert Lynn Mehler, experienced biopharmaceutical startup advisor Philip Katz and Randy Prebula, who gives regulatory advice to medical device and technology companies. Also DC-based is David Fox, who is known for his Hatch Waxman compliance expertise. Philadelphia-based team leader Steve Abrams is known for transactional work. Also recommended are DC-based Anishiya Abrol and Philadephia-based Blake Wilson.