Rachel Sher is the Deputy General Counsel at the Association for Accessible Medicines. She is responsible for providing legal advice, policy oversight and advocacy to AAM staff and member company representatives on a wide range of issues relating to generic and biosimilar medicines in the U.S.
Prior to joining AAM, Rachel served as Senior Policy Analyst in the Commissioner’s Office of Policy at the Food and Drug Administration (FDA). In that capacity, she acted as the FDA lead in the 21st Century Cures Act legislative process, providing strategic advice and guidance to the Commissioner and senior agency officials on the legislative and policy issues that were considered. As part of this process, Rachel helped formulate FDA policy and conducted discussions with bipartisan congressional staff on critical provisions for the generic drug and biosimilar industry.
For ten years before joining FDA, Rachel served as Senior FDA Counsel for Ranking Member (Formerly Chairman) Henry A. Waxman, both on the Democratic Committee Staff for the Energy and Commerce Committee, and in Representative Waxman’s personal office. She drafted and negotiated major FDA legislation, including the Drug Quality and Safety Act, the FDA Safety and Innovation Act, the Biologics Price Competition and Innovation Act (enacted as part of the Affordable Care Act), the Food Safety and Modernization Act, and the FDA Amendments Act of 2007.
Rachel holds degrees from the University of Florida Levin College of Law (J.D.), The George Washington University School of Public Health (M.P.H.), and Duke University (B.A.).