ANDREW ZACHER is Of Counsel in the FDA practice at Paul Hastings and is based on the firm’s Washington, D.C. office. With over 13 years of experience in government service, including serving as Acting Chief of Staff of the FDA and FDA Detailee to the Senate Health, Education, Labor, and Pensions (HELP) Committee, Andrew offers unique insight into the inner workings of FDA, HHS, and Capitol Hill as he helps clients navigate the complex FDA regulatory landscape.
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, Andrew 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 the leadership of all FDA product centers and field operations to support implementation of agency policies and served as the Commissioner’s direct liaison to other executive agencies and organizations on critical public health initiatives.
Prior to serving in FDA leadership, Andrew spent several years as Associate Chief Counsel for Drugs in the Office of the Chief Counsel where he 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 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 on Capitol Hill as the FDA Detailee to the Senate HELP Committee where he 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).
