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    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

Michael K. Stern

Of Counsel

Washington +1 202 662 5590

  • About
  • Representative Matters
  • Credentials
  • About

    Pharmaceutical companies rely on Michael Stern for his expertise in FDA regulatory strategy at all stages of the product life cycle.

    Michael helps leading and emerging drug and biotechnology companies:

    • Evaluate potential regulatory pathways,
    • Develop and implement a regulatory strategy that aligns with R&D, IP, and commercial considerations,
    • Resolve issues that arise in clinical trials or during FDA’s review of a marketing application, and
    • Develop additional innovations following initial approval.

    Clients often turn to Michael for his insights on exclusivity and orphan drug issues, drawing on his experience as an Associate Chief Counsel at FDA.

    Among other matters, Michael helps drug and biotechnology companies:

    • Pursue Hatch-Waxman, biological reference product, orphan drug, pediatric, and other forms of statutory exclusivity,
    • Qualify for Breakthrough Therapy, Fast Track, and priority review vouchers,
    • Appeal FDA decisions through formal dispute resolution,
    • Submit citizen petitions and comments to FDA dockets on appropriate approval standards for generic products and the availability of labeling “carve-outs,”
    • Plan for the withdrawal of products from the market, and
    • Conduct regulatory due diligence into target companies or assets.

    Before joining Covington, Michael served as an Associate Chief Counsel at FDA for six years. While at FDA, Michael specialized in regulatory issues including Hatch-Waxman, biosimilars, REMS, and user fees. He also worked with the U.S. Department of Justice’s Consumer Protection Branch to prosecute enforcement actions and defend FDA against legal challenges to agency decisions.

    Michael often speaks on FDA regulatory issues, both in the U.S. and abroad.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Advocated for eligibility for 5-year new chemical entity (NCE) exclusivity, 3-year new clinical investigation exclusivity, reference product exclusivity, and orphan-drug exclusivity.
    • Advised pharmaceutical companies on pediatric development and pediatric exclusivity issues.
    • Prepared citizen petitions for innovative pharmaceutical companies addressing appropriate bioequivalence methods, labeling carve-outs, active ingredient sameness, and other abbreviated new drug application (ANDA) approval issues, including for drug-device combination products and other complex products.
    • Advised pharmaceutical companies on regulatory strategy for section 505(b)(2) applications.
    • Served as an international expert on the U.S. patent linkage system in programs for judges and other officials in China on the amended Drug Administration Law and implementing regulations.
    • Advised pharmaceutical companies on REMS issues and responding to CREATES Act requests for samples of innovative products.

    Areas of Expertise

  • Credentials
    Education
    • The University of Chicago Law School, J.D., 2000
        • with honors
        • The University of Chicago Law Review, Member
    • Harvard University, A.B., 1995
        • magna cum laude
    Bar Admissions
    • District of Columbia
    • New York
    Government Experience
    • U.S. Department of Health and Human Services – Food and Drug Administration
    Judicial Clerkship
    • Hon. Mary M. Schroeder, U.S. Court of Appeals, Ninth Circuit, 2000 - 2001
    Memberships and Affiliations
    • Food and Drug Law Institute: Publications Peer Review Committee; Curriculum Advisor for Training Courses
    Previous Experience
    • U.S. Food and Drug Administration, Associate Chief Counsel (2010-2016)

    Areas of Expertise

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