Mark I. Schwartz

Adjunct Professor

B.S., McGill University; L.L.B., l'Université de Sherbrooke; L.L.M., Duke University School of Law

Contact Information

Biographical Sketch

Mark I. Schwartz is Associate Chief Counsel for Drugs and Biologics at the Food and Drug Administration.  He advises the FDA Commissioner, Chief Counsel, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research on a variety of constitutional, statutory and regulatory issues involving drugs and biologics. 

Mr. Schwartz's areas of interest include the drug and biologic approval process; the conduct of clinical trials; accelerated approval; post-marketing safety and regulatory issues; biosimilar and interchangeable biological products; drug compounding; combination products; HCT/Ps; Hatch–Waxman generic drug approvals; orphan drugs; supplemental new drug applications; exclusivity; advertising and promotional labeling; First Amendment issues (including off-label promotion and commercial versus fully protected speech); federal preemption; investigator disqualifications; license revocations; and the regulation of biotech foods.

Mr. Schwartz has spoken on behalf of the agency both in the United States and abroad, and has been an adjunct professor of food and drug law at Howard Law School, as well as a lecturer of food and drug law at other Washington, D.C. area law schools.  He has been on the editorial advisory board of the Food and Drug Law Journal, and has received numerous awards, including the Outstanding Service Award for outstanding performance in providing legal services to FDA on significant and complex issues, primarily involving biologics and conventional human drugs.

Mr. Schwartz has published extensively both in law journals (such as for the Food and Drug Law Journal, Commercial Law Journal, Tax Notes and McGill Law Journal) as well as in non-academic settings, such as for the New York Times, Wall Street Journal, Barron's, Forbes, Globe & Mail (Canada), Financial Post (Canada), Financial Times (Europe) and International Herald Tribune (Europe). 

Prior to joining FDA, Mr. Schwartz was a commercial litigator in Washington, D.C. and, before that, in his native Montreal, Canada.  He has law degrees from Duke University School of Law and l'Université de Sherbrooke (Canada), as well as a Bachelor of Science degree from McGill University (Canada).