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

    • Apr 08, 2021

Lewis A. Grossman

Of Counsel

Washington +1 202 662 5311

  • About
  • Representative Matters
  • Credentials
  • About

    Lewis Grossman, a leading academic authority on food and drug law, has represented food and drug clients in a wide variety of complex matters. He is a Professor of Law at American University's Washington College of Law and was an associate at Covington & Burling earlier in his career. He is the co-author with Covington's Peter Barton Hutt and Richard Merrill of Food and Drug Law: Cases and Materials (Foundation Press, 2014), a leading text in the field.

    Lewis has served as a member of or legal consultant to three different Institute of Medicine Committees, focused on dietary supplements, food, and pharmaceuticals, respectively. He has testified before the U.S. Senate on FDA regulation of tobacco products and acted as a legal consultant to Senator John McCain on Hatch -Waxman reform. He has lectured extensively on food and drug matters and is a member of the Board of Directors of the Food and Drug Law Institute. Lewis has also written a leading textbook on civil procedure.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Helped pharmaceutical company obtain formal dispute resolution regarding FDA denial of new drug application; represented the company in the subsequent formal dispute resolution process, including advisory committee meeting.
    • Coauthored white paper analyzing the constitutionality of the Biologics Price Competition and Innovation Act under the Takings Clause.
    • Advised major pharmaceutical company on resisting federal criminal prosecution inconsistent with prior FDA scientific determination.
    • On behalf of major multinational consumer products corporation, prepared brief to FDA on the market introduction of a direct-to-consumer version of a prescription medical device.
    • For a leading pharmaceutical company, examined procedural issues regarding potential withdrawal of a new animal drug application. 

    Areas of Expertise

  • Credentials
    Education
    • Yale University, Ph.D., 2005
        • George Washington Egleston Prize for Best Ph.D. Dissertation in the Field of American History (2005)
    • Harvard Law School, J.D., 1990
        • magna cum laude
    • Yale University, B.A., 1986
        • summa cum laude
    Bar Admissions
    • District of Columbia
    • New York
    Government Experience
    • U.S. Department of the Treasury
    Judicial Clerkship
    • Hon. Abner J. Mikva, U.S. Court of Appeals, District of Columbia Circuit, 1992 - 1993
    Pro Bono
    • Institute of Medicine of the National Academies: Member, Standing Committee for the CDC Division of Strategic National Stockpile (2015-present); Member, Committee for Review of FDA’s Role in Ensuring Safe Food (2009-2010); Legal Consultant, Committee on the Framework for Evaluating the Safety of Dietary Supplements (2002-2004).
    Accolades
    • Mellon Fellowship in the Humanities, Woodrow Wilson Foundation (1990)
    Memberships and Affiliations
    • Food and Drug Law Institute, Member, Board of Directors
    Previous Experience
    • U.S. Department of the Treasury, White House Security Review, Assistant Director (1994-1995)    

    Areas of Expertise

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