Major change and disruption for US FDA
- Date
- April 10, 2025
- Category
US Regulations
- Description
On taking office at the end of January, President Trump nominated Marty Makary to be the next FDA Commissioner and Robert F. Kennedy Jnr. to head the Department of Health and Human Services (HSS), the Department that FDA reports to. Both appointments needed to be ratified by the US Senate. The appointment of Robert F. Kennedy Jnr to be the Secretary of HHS was confirmed by the Senate on 13 February 2025. The appointment of Marty Makary as FDA Commissioner was confirmed by the Senate on 25 March 2025.
The FDA was subjected to significant disruption by Elon Musk’s Department of Government Efficiency (DOGE) who instigated an initial staff reduction of 600-700 people. One of the areas of FDA with the most initial layoffs was the Center for Devices and Radiological Health (CDRH) and its offices focused on artificial intelligence, digital health and cybersecurity being particularly hard hit, losing about 10% of their staff. However, other Centers, including those for Drugs and Foods, were also hit by significant reductions.
As well as laying off personnel the DOGE group have terminated the leases on 30 FDA offices or other properties.
As result of the layoffs FDA has lost many of their most experienced staff who are resigning or retiring from the agency:
- Jim Jones, the FDA Food Safety Leader resigned.
- Director of CBER, Dr Peter marks, announced his resignation sighting his significant concerns at the changes being made in his resignation letter, see https://www.documentcloud.org/... .
- CBER has also been badly hit by resignations from their cell and gene therapy staff.
The forced resignation of CBER Director Peter Marks, is worrying in that it sets an undesirable precedent that senior positions at FDA, as well as the role of the Commissioner, are now political appointments.
President Trump mandated that all federal workers must return to their offices and cease working from home from 17 March 2025. This caused further chaos for FDA staff due their being insufficient parking or office space at the main FDA headquarters at White Oak, MD.
With Robert F. Kennedy Jnr taking over at HHS in Q1 2025, a radical re-organization of FDA is being proposed. In early April 2025 it was reported that all of the existing Centers in FDA (CBER, CDER, CDRH CFSAN and the Center for Veterinary Medicines) would all be combined into a single regulatory office that would be known as the Office of Product Evaluation and Regulation.
A second FDA office would be the Office of Inspections, Compliance and Enforcement and would oversee all inspections, investigations, import operations and compliance enforcement. This office would include the Office of Inspections and Investigations that was newly set up just a few months prior, along with all of the compliance units currently in each center.
Industry has expressed concerns that the disruption at FDA will slowdown the approval of new product applications, in particular those for rare diseases and for novel drugs (e.g. for cell and gene therapy products).