Article Summary:
This week at the FDA, there are several notable developments. First, the FDA announced plans to revamp and simplify its policies for approving biosimilars, with the goal of increasing the number of these lower-cost alternatives to biologics on the market. FDA Commissioner Marty Makary stated that the agency will finalize guidance on when comparative efficacy studies are needed and on demonstrating biosimilar interchangeability.
Makary also discussed the challenges of transitioning from a clinical role to a political appointee leading the FDA, noting that the agency now faces more scrutiny and criticism compared to his prior position at Johns Hopkins. He emphasized the need to move beyond polarization and focus on uniting around health priorities.
The text also reports on tensions within the FDA’s Center for Biologics Evaluation and Research (CBER), where the director, Vinay Prasad, is said to be clashing with his staff. This has reportedly led to an exodus of scientists considering leaving CBER.
Additionally, the FDA has taken several regulatory actions, including restricting unapproved fluoride drugs for children, recalling blood pressure medication over cancer concerns, and approving fewer original generic drug applications in the last fiscal year. The agency also published draft guidances related to medical device quality systems and menstrual product performance testing.
Overall, the summary highlights the FDA’s efforts to streamline biosimilar approvals, manage internal tensions, and fulfill its regulatory responsibilities across drugs, biologics, and medical devices.