11 articles · Updated · The Wall Street Journal · May 3
Republicans in Congress and White House officials are reportedly losing patience after rare-disease and cancer drug rejections, whistleblower retaliation complaints and senior staff turmoil.
The criticism centres on blocked treatments including Replimune's melanoma therapy and UniQure's Huntington's gene therapy, while biologics chief Vinay Prasad has left after renewed clashes over approvals.
Makary has also angered anti-abortion conservatives over mifepristone policy and vaping advocates over flavoured products, deepening concerns that FDA leadership turmoil is delaying reviews and eroding trust.
Amid leadership turmoil, will the FDA's new 'one trial' policy actually speed up access to life-saving drugs?
As the FDA overrules its scientists on vaping and drugs, is its claim of scientific independence still credible?
Is the FDA's internal chaos creating an opportunity for other countries to become the new leaders in medical innovation?
FDA Under Fire: The 2025-2026 Crisis Over Mifepristone Safety, Leadership Turmoil, and Makary’s Controversial Reforms
Overview
From late 2025 through early 2026, the FDA faced intense political and institutional challenges under Commissioner Marty Makary. Pro-life groups launched a campaign demanding his removal, citing the FDA's approval of a generic mifepristone, a stalled safety review, and ongoing mail-order policies. Meanwhile, internal turmoil peaked with the controversial exit of Dr. Vinay Prasad amid disputes over regulatory decisions and whistleblower allegations of sidelined safety experts. In response, Makary pursued a transparency-focused reform agenda, making contentious decisions like rejecting Moderna's flu vaccine and easing hormone therapy warnings. These events fueled polarization, leadership uncertainty, and calls to scale back Makary’s role, placing the FDA at a critical crossroads for public trust and scientific independence.