This website uses cookies. For more information please contact us or consult our privacy policy.

Your binder contains too many pages, the maximum is 40.

We are unable to add this page to your binder, please try again later.

This page has been added to your binder.

Michael Stern
Michael K. Stern
Special Counsel
Washington +1 202 662 5590 mstern@cov.com Download V-card

Michael Stern helps clients solve FDA regulatory challenges relating to pharmaceuticals and biotechnology products. He has particular expertise with Hatch-Waxman and biosimilars issues, including regulatory exclusivity and life-cycle management strategies. Mr. Stern also advises clients on a broad range of other issues that often require engagement with FDA, including priority review vouchers, breakthrough therapy designation, Risk Evaluation and Mitigation Strategies (REMS), and user fees. Mr. Stern joined Covington from FDA, where he served as an Associate Chief Counsel from 2010 to 2016.

Hatch-Waxman

  • Develop life-cycle management strategies and advise clients on exclusivity-related issues.
  • Prepare citizen petitions for innovative companies addressing bioequivalence methods, labeling carve-outs, and other issues relating to ANDA approval.
  • Advise trade association and pharmaceutical industry clients on legislative proposals relating to single, shared system REMS and access to innovative products by developers of follow-on products.
  • Provide FDA regulatory expertise in Hatch-Waxman patent litigation.

Biologics and Biosimilars

  • Advise innovative clients on life-cycle management and nonproprietary naming.
  • Prepare comments on significant FDA draft guidance documents, including guidances on biosimilar labeling, transition products, and interchangeability.

Pharmaceutical Research and Development

  • Advise clients on eligibility for approval pathways, expedited programs, and priority review vouchers; assist clients in securing related designations from FDA.
  • Represent pharmaceutical companies in appeals of user fee (PDUFA) assessments.

Previous Experience

  • U.S. Food and Drug Administration, Associate Chief Counsel (2010-2016)