William Vodra is a retired partner who focused his practice on regulatory issues involving the safety, effectiveness, quality, and marketing of medical products, including pharmaceuticals, biologicals, medical devices, and combinations products. He led teams defending embattled products and represents companies in Food and Drug Administration (FDA) enforcement proceedings, white-collar criminal investigations, and civil litigation. He counseled clients on approval strategies, product life cycle management, promotional practices, safety monitoring and reporting, and good manufacturing practice and quality systems. His work also included dietary supplements, foods, and cosmetics.

Prior to joining Arnold & Porter, Mr. Vodra served as the Associate Chief Counsel for Drugs for FDA, and as Assistant Chief Counsel for DEA. He drafted many agency regulations still in use, including those implementing the Controlled Substances Act and FDA's rules for Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, bioequivalency, and the Orange Book. Since retiring in 2010, Mr. Vodra has served as a member of the Institute of Medicine’s Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, and at the request of the US Department of State as an expert witness on FDA law in an arbitration under the North American Free Trade Agreement.

Credentials

Education
  • JD, Columbia Law School, 1968
  • BA, College of Wooster, 1965
Admissions
  • District of Columbia
Activities
  • Trustee, Civil War Preservation Trust

Overview

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