Overview
Philip Katz is a partner in the Life Sciences Regulatory practice at Paul Hastings and is based in the firm’s Washington, D.C. office. He counsels pharmaceutical and biotechnology clients on FDA regulatory matters across the product life cycle. Having led the Band 1-ranked Pharmaceuticals and Biotechnology Regulatory practice at his previous firm, Phil brings deep regulatory knowledge and understanding of agency processes that enable him to advise clients of all sizes on their most business-critical regulatory matters. His clients range from startups developing their first product to large public companies with extensive product portfolios.
Much of Phil’s work involves providing strategic guidance on FDA engagement and advocacy in the approval process for new drugs and biologics, obtaining and using regulatory exclusivities, and helping clients navigate compliance matters, enforcement activities and business transactions involving FDA-regulated products.
Phil has particularly extensive experience with the Hatch-Waxman Act, Orphan Drug Act and Biosimilars Price Competition and Innovation Act. His knowledge of the law, business considerations and FDA precedents provides the basis for working with clients to develop and implement creative, practical and effective strategies to obtain approval for products and address post-market compliance issues in a highly regulated environment in which long-term relations with the FDA are essential.
Before joining Paul Hastings, Phil was a partner and long-time leader of the Pharmaceuticals and Biotechnology Regulatory practice at a global firm. During that period, he also served as a member and then chairman of the board of directors of the Food and Drug Law Institute.
Accolades
- Band 1: Pharmaceutical/Medical Products Regulatory: Washington, D.C. – Chambers USA
- Band 3: Life Sciences: Regulatory/Compliance: Nationwide – Chambers USA
- Band 3: Life Sciences: Regulatory/Compliance (USA) – Chambers Global
- Leading Practitioner: FDA: Pharmaceuticals – LMG Life Sciences
- Recommended for Healthcare: Life Sciences – Legal 500 US
- FDA Law: Best Lawyers in America
- Distinguished Service and Leadership Award: Food and Drug Law Institute
Education
- J.D., Georgetown University Law Center, magna cum laude, Order of the Coif, 1992
- B.A., University of Virginia, with distinction, 1981
Representations
- Represented Danco Laboratories in defending FDA’s approval of Mifeprex in a challenge to the availability of medication abortion.
- Assisted a client in developing FDA legal and regulatory strategy for obtaining approval and three-year exclusivity that was essential to commercial success.
- Developed and implemented a strategy that convinced FDA to reverse its denial of orphan drug designation for a company’s sole product and moved the product to approval and orphan drug exclusivity.
- Represented Depomed at FDA and in court to obtain orphan exclusivity for Gralise.
- Represented a senior executive in negotiating and operating under an FDA consent decree and subsequent Department of Justice investigation.
- Authored a successful FDA petition ensuring patent certification and opportunity for litigation and 30-month stay with competitor’s 505(b)(2) NDA.
- Successfully advocated to the FDA Exclusivity Board for favorable decision on the scope of three-year exclusivity.
- Advised senior management on developing and implementing an NDA resubmission strategy after a Complete Response Letter.
- Represented a reference listed drug sponsor in negotiating shared REMS with a generic competitor and advocating at the FDA on related issues.
- Advised an overseas manufacturer on responding to Form FDA 483 inspectional observations and subsequent Import Alert.
- Advised a company on FDA strategy for approval of first product, responded to competitor petitions and interacted with underwriters in an IPO.
Matters may have been completed before joining Paul Hastings.