Lowell M. Zeta, J.D. Deputy Commissioner for Strategic Initiatives and Special Counsel for FDA - Office of the Chief Counsel

Lowell M. Zeta, J.D.

Lowell M. Zeta, J.D., is the Deputy Commissioner for Strategic Initiatives at the U.S. Food and Drug Administration and serves as Special Counsel for FDA in the Office of the Chief Counsel (OCC), which is the Food and Drug Division of the U.S. Department of Health and Human Services’ (HHS) Office of the General Counsel. 

In this dual role, Mr. Zeta provides legal and strategic counsel to the FDA Commissioner and Agency leadership to advance strategic regulatory initiatives, drive cross-agency innovation, and strengthen oversight across all FDA-related product areas including drugs, biologics, food, medical devices, cosmetics, veterinary products, and tobacco products. He serves as the point-person ensuring that strategic initiatives and priorities, at all levels of the organization, are authorized under the Federal Food, Drug, and Cosmetic Act (FDCA) and other applicable laws and regulations, and are in line with the FDA Commissioner’s priorities and the broader goals of HHS and the Administration.

Mr. Zeta is responsible for collaborating with the FDA Commissioner to identify opportunities to improve regulatory programs, to develop innovative strategies to emerging and ongoing issues, and to implement new programs and solutions to achieve the FDA’s mission objectives. He works closely with FDA leadership and provides executive oversight for operations and regulatory process improvements. His responsibilities include providing analyses and recommendations on innovative regulatory initiatives and programs, ensuring the alignment of the key functions of strategy planning, and driving change and overseeing change management during implementation to maximize efficiency and public health benefit.  

As Special Counsel for FDA, Mr. Zeta provides legal counsel and strategic counsel on high-priority regulatory and administrative actions and cross-cutting legal issues involving emerging technologies such as artificial intelligence, domestic manufacturing and foreign inspections, and risk management for regulations, guidance, and policy development, which often involves complex legal analyses of intricate statutory provisions. He works closely with OCC litigators and counselors to advise FDA officials on strategy planning and risk mitigation approaches, new and pending regulations and draft legislation, and complex compliance and enforcement matters to advance FDA’s mission of promoting and protecting the public health. 

Mr. Zeta was previously with the FDA (2020-2021), serving as a Senior Advisor to the Commissioner, and provided leadership on key public health initiatives, including the Pandemic Recovery and Preparedness Plan (PREPP) initiative to strengthen the FDA’s response to public health emergencies. Prior to his return, Mr. Zeta was a senior partner at a global law firm in Washington, D.C., focusing on regulatory and commercial strategies, enforcement and administrative matters, compliance and investigations involving the pharmaceutical and biotech industries. In addition, he has extensive experience, and is a frequent speaker and published writer on FDA and healthcare priorities. Mr. Zeta previously served as a Food and Drug Law Journal advisory board member where he was responsible for peer-review of publications in the Food and Drug Law Journal, covering scholarly work on legislation, regulations, court decisions, and public policies affecting FDA regulated industries. Mr. Zeta completed his undergraduate studies at the University of Iowa and earned his juris doctor and postgraduate degree in law and health policy from Creighton University and Georgetown University, respectively.

---