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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.

  • 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. 

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).

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)    
  • Mellon Fellowship in the Humanities, Woodrow Wilson Foundation (1990)