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

Michael Stern advises pharmaceutical companies on their most complex, high-stakes FDA regulatory issues. With over 15 years of experience, he frequently counsels innovative drug and biotechnology companies on Hatch-Waxman, biosimilars, and orphan drug issues, including regulatory exclusivity and life-cycle management strategies. Clients consult Mr. Stern on a broad range of R&D-related issues, including strategies for application submission, engagement with FDA, qualifying for expedited programs and priority review vouchers, and Risk Evaluation and Mitigation Strategies (REMS). Mr. Stern joined Covington from FDA, where he served as an Associate Chief Counsel from 2010 to 2016.

Hatch-Waxman

  • Developed life-cycle management strategies for drug and digital health products.
  • Advised innovative pharmaceutical companies on exclusivity-related issues.
  • Prepared citizen petitions for innovative companies addressing bioequivalence methods, labeling carve-outs, active ingredient sameness, and other abbreviated new drug application (ANDA) approval issues.
  • Advised pharmaceutical companies on section 505(b)(2) issues.
  • Prepared comments and advised trade association and pharmaceutical industry clients on FDA’s Drug Competition Action Plan.

Biologics and Biosimilars

  • Advised innovative clients on life-cycle management, reference product exclusivity, and nonproprietary naming.
  • Prepared comments on FDA’s Biosimilars Action Plan and significant FDA draft guidance documents, including guidances on biosimilar labeling, transition products, and interchangeability.   

Pharmaceutical Research and Development

  • Advised pharmaceutical companies on orphan-drug issues, expedited programs (including breakthrough therapy and fast track), and priority review vouchers; assisted in securing related designations from FDA.
  • Developed strategies for application submission and selection of an appropriate approval pathway.
  • Advised pharmaceutical companies on interactions with FDA during the application review process, including through formal dispute resolution.
  • Advised drug developers on REMS and access to samples of innovative products by follow-on developers.

Previous Experience

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