Heidi Forster Gertner is a partner at Hogan Lovells with deep knowledge of the regulation of pharmaceutical products.
Prior to joining Hogan Lovells, Heidi worked for 13 years at the Food and Drug Administration's Office of Chief Counsel, most recently as a Senior Counsel for Drugs. While there, she regularly assisted the Center for Drug Evaluation and Research and the Office of the Commissioner on almost all aspects of human drug regulation. She was one of the primary attorneys providing legal advice to the agency on matters related to drug advertising and promotion and drug safety, and handled issues related to over-the-counter drugs, including prescription to over-the counter switches. For many years, she was the office's team leader on the complex regulation of combination products.
Heidi has extensive experience in the agency's use of Risk Evaluation and Minimization Strategies (REMS), required post-approval clinical studies and trials, and required safety label changes. She has considerable experience in clinical trial and investigational new drug issues and human subject protection. She also advised the agency on drug approvals and withdrawals, the Prescription Drug User Fee Act, clinical investigator disqualification, and federal preemption matters.
Heidi previously was a Post-Doctoral Bioethics Fellow at the National Institutes of Health in the Department of Clinical Bioethics and a Clinical Bioethics Fellow at the Cleveland Clinic Foundation in the Department of Bioethics. Currently she is an Adjunct Associate Professor at American University Washington College of Law, where she has been teaching a law class titled "Health Law: Bioethics" for 14 years.