Sheldon Bradshaw is a partner in King & Spalding’s Washington, D.C. office and a member of the FDA & Life Sciences practice. His practice focuses on providing legal and regulatory assistance to both small growth companies and large multinational corporations regarding products regulated by the Food and Drug Administration.
Mr. Bradshaw served as Chief Counsel at the U.S. Food and Drug Administration (FDA) from 2005 to 2007. As Chief Counsel, he was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA's senior leadership—including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers—on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. In addition, he oversaw all FDA-related litigation and reviewed and approved every significant regulation and guidance document promulgated by the FDA and every significant warning letter issued by the FDA. Prior to his service at the FDA, Mr. Bradshaw held several senior positions at the U.S. Department of Justice where he, among other things, provided advice to FDA and testified before Congress on matters under the FDA's jurisdiction. At King & Spalding, he advises clients in the same areas in which he worked while Chief Counsel of FDA. Prior to joining King & Spalding, Mr. Bradshaw was a partner at Hunton & Williams.
From 1996 to 1999, Mr. Bradshaw was a law clerk for the Hon. Karen J. Williams of the United States Court of Appeals for the Fourth Circuit. He is admitted to practice before the United States Court of Appeals for the Fourth and Fifth Circuits.
- Co-author, “FDA’s Proposed Generic Drug Labeling Rule,” The Food and Drug Law Institute, July/August 2014
- Co-author, “FDA Watch, New Compounding Legislation,” Contract Pharma, January 24, 2014
- Co-author, with Scott Gottlieb, “A Compounding Fracture at the FDA,” Wall Street Journal, November 13, 2012
- Co-author, “Did FDA Apply a Remedy Worse than the Disease in Refusing to Clear the Market of Unapproved Versions of Makena?” FDLI's Food and Drug Policy Forum, Volume 1, Issue 11, June 2011
- Co-author, “The FDA's Approval of Percocet and Vicodin,” Law360, July 15, 2009
- Co-author,” FDA Enforcement Crackdown Requires Reforms,” Law360, June, 30, 2009
- Co-author, “FDA: playing by its own rules?,” Scrip World Pharmaceutical News, November 7, 2008
- Author, “New FDA Guidance Documents,” 62 Food and Drug Law Journal 429-432, 2007
- Food and Drug Law Institute