Wade Ackerman served as Senior FDA Counsel to the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee until June 2016. In this role, he was intimately involved in legislative initiatives, oversight hearings, and other Senate activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act, and he interacted extensively with legal, policy, and government relations staff at companies marketing products regulated by the FDA. He worked closely with the FDA and other stakeholders as Congress examined legislative reforms in key areas, including drug and device innovation, health software, diagnostics/LDTs, cosmetics, and over-the-counter drugs. Most recently, he negotiated FDA provisions in the Senate’s companion legislation to the “21st Century Cures Act,” which includes various provisions aimed at fostering innovation in the development and approval of new pharmaceuticals, biologics, and medical devices.
Prior to his role in the Senate, Mr. Ackerman served for over five years as Associate Chief Counsel in the FDA’s Office of Chief Counsel, where he was responsible for providing legal advice to FDA’s Center for Drug Evaluation and Research and the Office of Commissioner on a wide range of legal and regulatory issues. He also helped develop and implement the Drug Quality and Security Act (DQSA) of 2013 and the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012—both significant reforms to FDA’s regulatory authorities.
Mr. Ackerman’s deep understanding of and unique insight into the legal and regulatory issues facing companies marketing FDA-regulated products, gained through more than a decade of experience in private practice and positions within the FDA and on Capitol Hill, enhances Covington’s internationally leading Food, Drug, and Device Practice.