Heidi Gertner has been a drugs counselor in the Office of the Chief Counsel of the U.S. Food and Drug Administration (FDA) for the past ten years. Her areas of expertise are over-the-counter drug product regulation, drug safety, drug marketing and advertising, human subject protection, preemption, and combination products. Prior to joining FDA, Ms. Gertner was a Bioethics Fellow in the Department of Clinical Bioethics of the U.S. National Institutes of Health from 1999 to 2001. Ms. Gertner is also an Adjunct Associate Professor at American University's Washington College of Law.
Also before joining FDA, Ms. Gertner was a Visiting Assistant Professor at Case Western Reserve University's Schools of Law and Medicine. She has published two law review articles, one of which was cited by the Massachusetts Supreme Court. She has also published articles in The Lancet, Archives of Internal Medicine, Obstetrics & Gynecology, The Journal of Clinical Ethics, and Cambridge Healthcare Ethics Quarterly, among others.
From 1997-1998, Ms. Gertner was a Clinical Bioethics Fellow at the Cleveland Clinic Foundation. Ms. Gertner has given lectures in Helsinki and London. She graduated cum laude from Binghamton University in 1994, and from Washington University School of Law in 1997 where she was a staff member of the Washington University Law Review Quarterly.