Heidi Gertner works at the forefront of the drug regulatory industry. She provides insight to large and small pharmaceutical companies and research institutions in dealing with government regulators to maximize business potential.
With her wealth of drug regulatory knowledge and creative thinking skills, Heidi finds solutions to client problems and is a tireless advocate. She helps clients resolve their enforcement differences with the FDA and facilitates positive relationships with the agency. Heidi anticipates and helps clients dealing with cutting-edge issues, both by assessing policy initiatives and finding new business opportunities.
Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships, one at the Cleveland Clinic Foundation, and another at the National Institutes of Health. At the National Institutes of Health, Heidi’s work focused primarily on human subject protection and research ethics issues.
Heidi honed her legal skills at the FDA’s Office of Chief Counsel, where she advised government regulators on almost all aspects of drug regulation for 13 years. At the FDA, Heidi’s portfolio focused on drug advertising and promotion, combination products, drug safety, clinical trials and human subject protection, Rx-OTC switches, and over-the-counter drug regulation. While at the agency, she oversaw numerous rulemaking and enforcement actions. As one of a handful of senior lawyers, Heidi worked closely with the Center for Drugs, HHS officials, and congressional staff.
Heidi joined Hogan Lovells in 2014 and calls the D.C. office her home base. She is plugged into the D.C. regulatory scene and works closely with companies and research institutions on developing regulatory and business strategy. She is an integral part of the skilled team of drug regulatory lawyers and works across numerous groups within the firm to provide clients with comprehensive legal and business advice. She is also an adjunct professor of law at American University’s Washington College of Law, where she has challenged students in her Health Law Bioethics class for the past 15 years.