Article Summary:
The FDA is facing scrutiny this week on several fronts. Anti-abortion groups are calling for the resignation of FDA Commissioner Marty Makary, alleging he has delayed a safety review of the abortion drug mifepristone until after the 2026 midterm elections. The White House has defended Makary, saying the review is not being held up.
The FDA is also investigating potential COVID-19 vaccine-related deaths across multiple age groups, following claims by a senior FDA official that the vaccines have killed at least 10 children. Additionally, the agency is reviewing respiratory syncytial virus (RSV) vaccines after concerns were raised about their safety.
There are concerns about the recent appointment of Tracy Beth Høeg as acting director of the Center for Drug Evaluation and Research (CDER). Some FDA officials view her as a vaccine skeptic and fear her appointment could lead to high-level resignations.
On the drug and biologics front, an FDA panel has recommended easing restrictions on testosterone replacement therapy. The agency also approved Gamida Cell’s drug Omisirge to treat severe aplastic anemia, and Fondazione Telethon ETS’ Waskyra as the first cell-based gene therapy for Wiskott-Aldrich syndrome.
Additionally, the FDA proposed allowing the ingredient bemotrizinol to be added to sunscreens and qualified the first AI-based tool to assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity.
In the medical device space, the FDA’s Center for Devices and Radiological Health continues to expand its Total Product Lifecycle Advisory Program (TAP) pilot. Former FDA official David McMullen has also joined Elon Musk’s Neuralink,