Trump dismantles FDA expert committees

Critics of Trump’s plan to exclude external expertise warn of a retreat into opacity. Former FDA Commissioner Robert Califf, alongside academics such as Holly Fernandez Lynch (University of Pennsylvania) and Reshma Ramachandran (Yale), stressed that advisory committees not only provide additional scientific scrutiny but also offer one of the few opportunities for the public to observe FDA decision-making. Lawsuits such as that of Public Citizen, challenging the heavily redacted disclosure of committee members’ CVs, underline that credibility and openness have long been contested. However, while Trump is portraying himself as a white knight fighting corruption with his decision, this could enable precisely that behind closed doors.

The controversial approval of Biogen’s Alzheimer’s drug Aduhelm illustrates what is at stake: the FDA authorised the product despite a negative advisory vote – sparking fierce backlash. Studies show that the agency follows its committees in the vast majority of cases, which makes the push to dismantle them even harder to justify.

While advocates of the reform portray it as a way to cut red tape, the trade press has voiced strong doubts. BioCentury called the move “disappointing”, arguing that the FDA is tinkering with procedures while failing to strengthen the quality and independence of its advisory process. The suspicion remains that this is less about modernisation than about political alignment within the agency.

Real-time publication of complete response letters have only been started  recently. Until then, they were accessible solely through Freedom of Information Act (FOIA) requests. The FDA released an initial batch of 89 rejection letters, which Commissioner Marty Makary hailed as a historic step towards openness. Yet critics argue that the letters are no substitute for public committee hearings, which expose the reasoning process in real time.