Katlin McKelvie is a partner in the Washington, D.C. office of Gibson, Dunn & Crutcher and a member of the firm’s Food and Drug Administration (FDA) and Health Care Practice Group. With over two decades of experience in food and drug law, including as Deputy General Counsel of the Department of Health and Human Services (HHS), Katlin offers clients expansive knowledge of the complex legal and policy issues associated with FDA regulation of food, drugs, medical devices, and cosmetics.
As Deputy General Counsel at HHS, Katlin was responsible for advising senior HHS officials on FDA-related regulatory, enforcement, and litigation matters. Prior to joining HHS, she served as Deputy Health Policy Director and Senior FDA Counsel to the Senate Committee on Health, Education, Labor, and Pensions for Chair Patty Murray. As Committee staff, Katlin played a pivotal role in shaping multiple pieces of legislation the FDA is currently working to implement, most notably the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Food and Drug Omnibus Reform Act of 2022 (FDORA). Before her time in the Senate, Katlin spent 11 years at FDA, first as Regulatory Counsel in the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research and then as Associate Chief Counsel for Drugs in the Office of the Chief Counsel.
Katlin received her undergraduate degree, cum laude, with honors from Davidson College, and her J.D., cum laude, from the Georgetown University Law Center, where she was Executive Editor of The Georgetown Law Journal. She clerked for Judge Douglas P. Woodlock on the U.S. District Court for the District of Massachusetts and then worked in private practice with a focus on food and drug law.
Katlin is admitted to practice law in the District of Columbia.
Capabilities
- FDA and Health Care
- Administrative Law and Regulatory Practice
- Crisis Management
- False Claims Act / Qui Tam Defense
- Life Sciences
- Public Policy
- White Collar Defense and Investigations
Credentials
Education:
- Georgetown University - 2001 Juris Doctor
- Davidson College - 1996 Bachelor of Arts
Admissions:
- District of Columbia Bar
Clerkships:
- USDC, Massachusetts, Douglas P. Woodlock, 2002 - 2003