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, we discuss four key updates:
- The latest FDA leadership changes
- FDA Commissioner Makary confirms that FDA will not undergo reorganization
- Rehiring efforts following staff terminations and
- Uncertainty around the Center for Drug Evaluation and Research (CDER) Office of the Ombudsman
Recent FDA Leadership Changes
On May 6, 2025, Commissioner Makary announced via the social media platform X that Dr. Vinay Prasad will be the next director of the Center for Biologics Evaluation and Research, succeeding Dr. Peter Marks, who resigned from FDA in April. Additionally, Politico reported that Jeremy Walsh will serve as the Agency's inaugural chief artificial intelligence (AI) officer. While FDA welcomed these new leaders, it was reported that Michael Rogers, the associate commissioner for inspections and investigations, will retire from the Agency. Rogers' departure comes as FDA plans to increase unannounced inspections at foreign manufacturing facilities that make food, essential medicines, and other medical products for U.S. consumers and patients.
Update: Commissioner Makary Confirms That FDA Will Not Be Reorganized
As we previously discussed in our 100-day review of the second Trump administration, it was reported that HHS had considered a plan to reorganize FDA into five or six offices by combining similar activities of the centers, such as product reviews, policy, and inspections, into single offices. However, on April 29, 2025, Commissioner Marty Makary stated in an interview with MedPage Today that FDA will not be reorganized. Instead, FDA plans to consolidate information technology and travel offices, as well as "other things that make sense for efficiency." Dr. Makary mentioned that a reorganization plan for FDA had been proposed, but that he rejected it.
Rehiring of Some FDA Staff
Dr. Makary's confirmation provides relief to those concerned about how the plan might have affected FDA's ability to review regulated products, especially considering that the Agency recently lost a significant number of staff because of workforce reduction. Relatedly, it was reported that FDA will rehire some employees who were fired during the April workforce reduction or has asked them to return, including food safety scientists, those who make travel arrangements for safety inspectors, employees who handled Freedom of Information Act requests, and user fee negotiation personnel.
CDER Ombudsman in Limbo: What This Means for Drug Application Reviews
CDER's Office of the Ombudsman, which investigates complaints and resolves disputes between CDER and stakeholders, may be closed. However, it is unclear whether this closure will be permanent or temporary. On April 18, 2025, Bloomberg Law reported receiving an automated email from the office stating that its "services are currently unavailable" and recommending that the recipient contact the office again in May, when it anticipates having additional information. According to the report, a source confirmed that staff in the Office of the Ombudsman were included in the staffing cuts at FDA. Additionally, the news outlet received another automated email stating that Virginia Behr, the CDER ombudsman, retired on April 10, 2025.
At this time, there has been no update on the status of the CDER Ombudsman's office or whether operations have resumed since the news was first reported. The potential closure of the Ombudsman's office would be impactful, as the office served as a key resource for efficiently, quickly, and informally resolving regulatory, scientific, and administrative disputes that may arise during the drug review process.
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.