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Hogan Lovells Adds FDA Senior Counsel to Government Regulatory Practice

03 November 2014

WASHINGTON, D.C. 3 November, 2014 – Hogan Lovells is pleased to announce that Heidi Gertner has joined the firm as a partner in the firm’s Government Regulatory practice. She will be part of the Pharmaceutical and Biotechnology practice group.

Gertner comes to Hogan Lovells from the Office of the Chief Counsel (OCC) of the U.S. Food and Drug Administration (FDA), where she was most recently a Senior Counsel to the Center for Drug Evaluation and Research (CDER), and leader of the OTC Drugs Team and FDAAA Safety Team.  During her 13-year tenure at FDA, Gertner focused on legal and policy issues related to drug advertising and promotion (she was the most senior lawyer advising the Office of Prescription Drug Promotion); drug safety issues, including Risk Mitigation and Evaluation Strategies (REMS), safety labeling changes, and post-marketing requirements; and combination products and product jurisdiction, among other areas.

“Heidi’s experience with issues that our clients confront every day is exactly what we need to continue expanding our thriving practice,” said Meredith Manning, co-director of Hogan Lovells’ Pharmaceutical and Biotechnology practice group.

“The knowledge she has from 13 years at FDA – not just about the law, but about FDA policies, priorities, and practices – will allow Heidi to join us in providing creative, practical advice to help clients successfully conduct their business, which is what we do,” continued Philip Katz, practice group co-director.

In addition to practicing law, Gertner has completed post-doctoral fellowships in bioethics both at The Cleveland Clinic Foundation and the National Institutes of Health, and was a visiting assistant professor of bioethics at the law and medical schools of Case Western Reserve University.  She is currently an adjunct associate professor at American University’s Washington College of Law, a position she has held for 14 years and will continue while at Hogan Lovells.  She is a widely published author of articles in law reviews, medical journals, and ethics journals, as well as book chapters.

“I am eager to become part of Hogan Lovells,” said Gertner. “I look forward to helping the firm continue building and growing its leading drug regulatory practice.”

Gertner received her J.D. from Washington University School of Law and her B.A. from Binghamton University (State University of New York).

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