Donald O. Beers

DONALD O. BEERS retired from the Office of the Chief Counsel of the Food and Drug Administration in September of 2021. He served two tours of duty in that office, as a young lawyer from 1975 to 1985 and again from 2008 until his retirement. During his first tour, he was a litigator and handled for FDA a series of cases that culminated in United States v. Generix Drug Corp., 460 U.S. 453 (1983), which established that generic drugs must be approved by FDA before they can be marketed and led to the need for the Hatch-Waxman Act. From 1987 to 2008, he was a partner in the law firm Arnold & Porter and from 1985 to 1987 he was of counsel to McCutchen, Doyle, Brown & Enersen. In those positions he advised and represented companies regulated by the Food and Drug Administration. His book Generic and Innovator Drugs: A Guide to FDA Approval Requirements, which focuses on issues raised by the Hatch-Waxman Act and related legislation, was first published in 1988. He updated and expanded that work during the following years until he returned to government service. (Since that time all updates have been handled by Kurt Karst.) When he returned to FDA in 2008, his responsibilities included issues relating to regulation of human drugs, including implementation of the Hatch-Waxman Act, and emergency preparedness issues, including those relating to Ebola and Covid.