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 heads the firm's Pharma/Biotech Practice Group, which has 20+ 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 recently served as Chairman of the board of directors of the Food and Drug Law Institute, which capped years of activity at the institute. His leading role in the food and drug bar is reflected in many 2015 recognitions, including Legal 500 – Healthcare/Life Sciences, LMG Life Sciences – Regulatory Star, Best Lawyers in America – FDA Law, Who's Who Legal – Life Sciences/Regulatory, and Chambers – Recognized Practitioner.
Areas of Focus
Represented Depomed at FDA and in court to obtain orphan exclusivity for Gralise.
Represented senior executive in negotiating and operating under FDA consent decree and subsequent DOJ investigation.
Authored successful FDA petition ensuring patent certification and opportunity for litigation and 30-month stay with competitor's 505(b)(2) NDA.
Successfully advocated to FDA Exclusivity Board for favorable decision on scope of 3-year exclusivity.
Worked with senior management to help a company develop and implement an NDA resubmission strategy after a Complete Response Letter.
Represented reference listed drug sponsor in negotiating shared REMS with generic competitor and advocating at FDA on related issues.
Represented overseas manufacturer in responding to Form FDA 483 inspectional observations and subsequent Import Alert.
Advised company with FDA strategy for approval of first product, responded to competitor petitions, and interacted with underwriters in IPO.
Healthcare: Pharmaceutical/Medical Products Regulatory – District of Columbia
The Best Lawyers of America
Healthcare: Life Sciences
LMG Life Sciences
PLC Life Sciences Cross-border Handbook
USA – Life Sciences: Regulatory, Recommended
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