With over 13 years of experience in government service, including serving as Acting Chief of Staff of the FDA and FDA Detailee to the U.S. Senate Health, Education, Labor, & Pensions Committee, Andrew Zacher offers unique insight into the inner workings of the FDA, HHS, and Capitol Hill. He has advised a network of top-level officials across all branches of government on complex, high-profile, and time-sensitive regulatory and public policy matters.
Andrew’s practice focuses on providing legal and public policy advice to both traditional medical product companies and new market entrants who are navigating the system for the first time. His in-depth knowledge on an array of policies and regulations affecting FDA-regulated products positions him to help clients navigate this complex regulatory landscape and provide advice on all aspects of business decision-making throughout an FDA-regulated product’s lifecycle.
Experience
During his tenure at the FDA, Andrew held various positions advising senior officials on legal, regulatory, enforcement, and policy matters. As Deputy Chief of Staff and Acting Chief of Staff, he provided strategic direction to senior leadership to manage the agency’s response to public health crises and advance the FDA’s policy priorities. He worked closely with leadership across all FDA product centers and field operations to support implementation of agency policies and services as the Commissioner’s direct liaison to other executive agencies and organization on critical public health initiatives.
While serving as Associate Chief Counsel for Drugs, Andrew handled high-profile legal matters with a focus on complex issues affecting drug development and regulation. He was also Senior Regulatory Counsel in the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research where he worked to resolve legal and policy issues related to biologic drug development programs. Andrew also served for almost two years as the FDA Detailee to the Senate HELP Committee and played a critical role in crafting and negotiating legislation such as the Food and Drug Omnibus Reform Act of 2022 (FDORA) and the Verifying Accurate Leading-edge IVCT Development Act (VALID Act). Throughout his time at the FDA, he received many awards and recognitions, including the FDA Commissioner’s Outstanding Service Award in 2019 and the HHS Office of General Counsel’s Excellence in Service Award in 2020.
Perspectives
Recognition
Credentials
Education
- J.D., Albany Law School of Union University, 2010, magna cum laude
- J.D., Bioethics, Union Graduate College/Mount Sinai School of Medicine, 2010, magna cum laude
- B.S., Rensselaer Polytechnic Institute, 2007
Admissions
- New York
- *Admitted only in New York; practicing law in the District of Columbia during the pendency of his application for admission to the D.C. Bar and under the supervision of lawyers of the firm who are members in good standing of the D.C. Bar.
Government & Military Service
- Deputy Chief of Staff/Acting Chief of Staff, U.S. Food and Drug Administration (2023-2024)
- Health Policy Advisor (FDA Detailee), U.S. Senate, Committee on Health, Education, Labor, & Pensions, U.S. Food and Drug Administration (2021-2023)
- Senior Policy Advisor, Office of the Commissioner, U.S. Food and Drug Administration (2023)
- Senior Regulatory Counsel, Office of Therapeutic Biologics and Biosimilars, U.S. Food and Drug Administration (2020-2023)
- Associate Chief Counsel, Office of the Chief Counsel, Food and Drug Administration (2015-2020)
- Attorney, Office of the General Counsel, U.S. Department of Health & Human Services (2011-2015)
- Legislative Fellow, New York State Senate (2010-2011)