Marian J. Lee is a partner in Gibson, Dunn & Crutcher’s Washington, D.C. office. She provides FDA regulatory and compliance counseling to life science and health care companies. Ms. Lee has significant experience advising clients on FDA regulatory strategy, risk management, and enforcement actions. She regularly advises companies during FDA inspections and investigations, and she has led an array of regulatory assessments for mergers, acquisitions, and other transactions involving FDA-regulated entities. Ms. Lee also counsels on FTC matters relating to the marketing of foods, cosmetics, over-the-counter (OTC) drugs, and other health care products. She is a frequent speaker and author on developments in FDA and FTC law, including the evolving regulation of manufacturers’ speech and off-label communications, mobile health, and medical software.
The Best Lawyers in America® 2018, based on peer reviews, has recognized Ms. Lee in the field of FDA law. Law360 selected her as a “Rising Star,” one of four attorneys chosen in her field nationwide. Legal Bisnow named her one of the “Top 40 Lawyers Under 40” in Washington, D.C. Ms. Lee is a member of the Food and Drug Law Institute’s (FDLI) Publication Advisory Board and previously served on the Law360 Life Sciences Editorial Advisory Board and the FDLI Policy Forum. She is a graduate of Harvard Law School and Harvard College, magna cum laude and Phi Beta Kappa.
Areas of Practice
Drug & Medical Device
Food & Beverage
Science & Technology
Biotechnology, medical device, life sciences
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