Medicines, Fda turns the spotlight off review committees

The US Food and drug administration (Fda) is changing its skin. Under the Trump administration, the agency has started to downsize the role of the expert advisory committees that for decades have accompanied the most sensitive decisions on new drugs. According to the top management, these public meetings are redundant, wasteful and slow down processes.

George Tidmarsh, head of the Centre for drug evaluation and research, explained that resources should focus on cross-cutting 'big questions', such as setting parameters for entire drug classes. For individual products, he argues, the publication of 'complete response letters' - the documents with which the FDA informs companies of the reasons for a rejection - is sufficient. A step that, according to the agency, guarantees the same transparency as public meetings.

However, the choice sparked a strong debate. Former commissioners and academics recall that advisory committees, created in 1972, not only help FDA scientists assess risks and benefits, but also provide a rare opportunity to make the decision-making process visible to the public. "Experts ask questions that often neither the FDA nor companies had asked," notes Holly Fernandez Lynch, Professor of Bioethics at the University of Pennsylvania.

The case of aducanumab, an Alzheimer's drug approved despite a vote against by the committee, remains emblematic. For many, it showed how fragile the balance is between industry pressure, patient expectations and rigorous scientific analysis.

Then there is the issue of representation. Committee meetings are public, members are chosen for competence and transparency on conflicts of interest, and their opinions - while not binding - have historically had a strong influence on agency decisions. One study showed that the Fda was aligned with 97% positive votes and 67% negative votes.