Samantha Hong advises clients in the food, drug, cosmetic, dietary supplement, and tobacco industries on wide-ranging legal and regulatory matters related to the Food and Drug Administration (FDA) and other federal and state agencies. As a former attorney at FDA, Samantha brings valuable insight regarding regulatory compliance matters and FDA enforcement actions.
Prior to joining Kleinfeld, Kaplan & Becker, Samantha served as an Associate Chief Counsel in the Office of the Chief Counsel at FDA where she handled enforcement matters across all product areas and litigated challenges to agency actions on issues ranging from drug exclusivity and tobacco product policies to emergency use authorizations. In this role, Samantha worked closely with the U.S. Department of Justice and was responsible for advising senior agency officials on case strategy, implications for agency policy development, and settlement negotiations.
Samantha also previously served in the Office of the General Counsel at the U.S. Department of Health & Human Services (HHS) where she advised various HHS components including the Office of Research Integrity and the National Vaccine Program Office. Prior to her government tenure, Samantha worked as a patent litigator at two international law firms.
Publications & Speaking Engagements
- Presenter, “Clinical Investigations,” Food and Drug Law Institute’s Intro to Medical Device Law and Regulation (April 11, 2023)
- Panelist, “Don’t Let the Omnibus be Ominous: Important Updates for FDA-Regulated Industry,” Food and Drug Law Institute Virtual Event (March 2, 2023)
- Moderator, “Practicing Food Law Today: What You Must Know,” Food and Drug Law Institute Virtual Lunch and Learn (September 27, 2022)
- Presenter, “Clinical Investigations,” Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation Virtual Course (April 13, 2022).
- Presenter, “Informed Consent, Institutional Review Boards (IRBs), Protection of Human Rights,” and “Investigational Device Exemptions,” Food and Drug Law Institute / FDA Center for Devices and Radiological Health Introduction to Medical Device Law & Regulation Virtual In-House Training (2021-2023).
- Presenter/Interviewer, Fireside Chat with FDA Keynote Speaker on “Biosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation,” ACI 12th (Virtual) Summit on Biosimilars and Innovator Biologics (June 22, 2021).
Recognition & Professional Activities
- Member, New to Food and Drug Law Committee, Food and Drug Law Institute (2022-2023)
- FDA Office of the Commissioner Outstanding Service Award, 2020
M.P.H., Harvard T.H. Chan School of Public Health
B.A., Rice University (magna cum laude)
District of Columbia