Innovative life sciences companies rely on Michael Stern for his deep experience in FDA regulatory strategy.
Drawing on his experience at the U.S. Food and Drug Administration, Michael Stern advises pharmaceutical and biotech companies on life-cycle management, FDA’s regulation of the development of drugs and biologics, and the drug pricing provisions of the Inflation Reduction Act (IRA). Michael is a leading expert on regulatory issues relating to Hatch-Waxman and the Biologics Price Competition and Innovation Act, including exclusivity and FDA-related patent issues, as well as R&D and exclusivity issues relating to orphan drugs and pediatric studies.
Michael regularly counsels clients on regulatory policy and legislative issues affecting the life sciences industry. In addition, he advises life sciences clients on citizen petitions, Prescription Drug User Fee Act (PDUFA) issues, FDA’s expedited programs (including Breakthrough Therapy and Fast Track), the CREATES Act, and priority review vouchers.
Michael routinely leads regulatory due diligence and the regulatory review of transaction agreements in complex strategic alliance and M&A transactions between life sciences companies. He also works closely with Covington’s patent litigators on innovator-side patent litigation.
Before joining Covington, Michael served as an Associate Chief Counsel at FDA for six years. While at FDA, Michael provided strategic advice to FDA’s Center for Drug Evaluation and Research on Hatch-Waxman, the implementation of the biosimilars program and the Generic Drug User Fee Act (GDUFA), and legislative proposals. He also worked with the U.S. Department of Justice to prosecute enforcement actions and defend FDA against legal challenges to agency decisions.
Prior to joining FDA, Michael spent several years in private practice, focusing on intellectual property and complex commercial litigation.
Michael regularly speaks on FDA regulatory issues and the IRA, both in the U.S. and abroad. He is the author of the U.S. chapter in Pharmaceutical Test Data Exclusivity: A Multi-Jurisdictional Survey (Wolters Kluwer).
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