Article Summary:
This week at the FDA, there have been several notable developments. The director of the FDA’s Center for Biologics Evaluation and Research, Vinay Prasad, was forced to resign after only three months on the job. Prasad faced criticism from right-wing figures who accused him of working to sabotage the Trump administration’s plans for the agency, particularly related to the approval of Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys.
The FDA has also recommended classifying certain kratom-derived products as controlled substances due to their potential for abuse, and is requiring changes to opioid labeling to further stress their risks. Additionally, the agency has made its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program a permanent drug development tool qualification program.
In the medical device space, the FDA has reminded stakeholders of an upcoming public meeting to reauthorize the Medical Device User Fee Amendments (MDUFA VIII). The agency has also recognized a new International Electrotechnical Commission standard for in vitro diagnostics.
Politically, the FDA Commissioner, Marty Makary, has faced criticism from leading House Democrats over the agency’s recent decisions to change its vaccine approval policies. Meanwhile, the Trump administration is reportedly considering splitting the Center for Biologics Evaluation and Research into two new centers focused on vaccines and therapeutics.
Overall, this week has seen a mix of regulatory actions, personnel changes, and political tensions surrounding the FDA’s activities in the drug, medical device, and vaccine spaces.