Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions. This week's updates are as follows:
- FDA welcomes new Tobacco and Inspections leadership
- Commissioner Makary speaks on FDA budget and staffing cuts during appearance on Capitol Hill
FDA Announces New Leadership in Tobacco Center and Inspections Office
Last week, FDA announced Dr. Elizabeth Miller will be acting associate commissioner for inspections and investigations, replacing Michael Rogers, who retired from the Agency in early May. According to Dr. Miller's leadership profile, she recently served as the deputy associate commissioner for medical products and previously held the position of assistant commissioner for medical products and tobacco operations. At the same time, the Agency welcomed Dr. Bret Koplow as acting director of the Center for Tobacco Products (CTP). Dr. Koplow's leadership profile states that he previously served as senior counselor to the commissioner in the Immediate Office of the Commissioner, where his work included policy, regulatory, and operational matters involving CTP, such as e-cigarettes and tobacco products. Dr. Koplow replaces Dr. Brian King, who was fired during the April staffing cuts within FDA.
Commissioner Makary Speaks on Staffing Cuts During Senate Budget Hearing
Several news outlets reported on FDA Commissioner Makary's May 22 appearance before a Senate Appropriations Subcommittee regarding FDA's $6.8 billion budget request for the 2026 fiscal year. Of the $6.8 billion budget, $3.2 billion will be in budget authority and the remaining $3.6 billion in user fees—an overall 5.5% reduction and an 11.5% reduction in budget authority compared with this fiscal year's budget.
Notably, during the hearing, Dr. Makary was questioned about the impact of the April staffing cuts on the Agency's ability to efficiently operate, particularly in approving rare disease drug applications. Dr. Makary said that staffing cuts had not impacted approval schedules, but delays in reviews may occur because of the complexity of the drugs, and the Agency is on pace to meet all PDUFA deadlines. However, Dr. Makary admitted that the Agency has rehired some employees who were terminated during the staffing cuts. The ranking member of the subcommittee stated that information on where the staffing cuts occurred within FDA centers and offices was needed as they write the Agency's budget.
Venable will continue to monitor all changes regarding FDA and report any critical developments. If you have questions on how the contents of this article may impact you or your business's interactions with FDA, please contact the authors today.