Michael Stern provides strategic advice to clients on regulatory matters involving the U.S. Food and Drug Administration (FDA), with a focus on FDA’s regulation of pharmaceuticals and biotechnology products. He has significant experience with Hatch-Waxman and biosimilars issues, in addition to Risk Evaluation and Mitigation Strategies (REMS), pharmacy compounding, and the importation of FDA-regulated products.
Mr. Stern joined Covington from FDA, where he served as an Associate Chief Counsel from 2010 to 2016. While at FDA, Mr. Stern provided legal advice to FDA officials on Hatch-Waxman and biosimilars matters that raised complex legal and scientific issues, including market exclusivity, labeling carve-outs, bioequivalence, and the single, shared system REMS requirement for generic drug products. Mr. Stern also advised FDA officials on the implementation of the Biologics Price Competition and Innovation Act (BPCIA), the Generic Drug User Fee Amendments (GDUFA), and the Compounding Quality Act. In addition, Mr. Stern worked with the U.S. Department of Justice (DOJ) to defend FDA against legal challenges to agency decisions relating to drug approval, health claims on food products, and the admissibility of imports. Mr. Stern also worked with DOJ to prosecute injunction and seizure actions involving drugs, medical devices, and foods, and negotiated consent decrees to resolve those enforcement actions.
Before joining FDA, Mr. Stern was a lawyer in private practice. He represented clients in a broad range of litigation matters, including Hatch-Waxman patent litigation and an antitrust case relating to life cycle management. Mr. Stern also provided FDA regulatory advice to trade association and pharmaceutical industry clients.