Through more than a decade of experience in private practice and positions within the FDA and on the Hill, Wade Ackerman has acquired a deep understanding of and unique insight into the legal and regulatory issues facing companies marketing FDA-regulated products. Mr. Ackerman advises clients on FDA regulatory matters across a range of sectors, including drugs and biologics, medical devices, health software, cosmetics, and dietary supplements.
Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions (HELP) Committee. In this role, he was involved in legislative initiatives, oversight hearings, and other Senate activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. From January 2015 through June 2016, he helped negotiate many of the FDA-related provisions in the 21st Century Cures Act, including reforms to FDA’s review and approval of drugs, devices, combination products, health software, and medical countermeasures. He also worked closely with the FDA and other stakeholders as Congress examined legislative reforms in other key areas, including diagnostics/LDTs, cosmetics, and over-the-counter drugs.
Before taking his Senate role, Mr. Ackerman served for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel. He was responsible for providing legal advice to the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of issues. While at FDA, he also helped to develop and implement the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013—both significant reforms to FDA’s regulatory authorities.