FDA Shifts Away From Expert Reviews, Raising Transparency Concerns
Washington, D.C. – The Food and Drug Management is increasingly sidestepping recommendations from its autonomous advisory committees, sparking criticism that the agency is consolidating power and diminishing public input in drug approval processes.Recent actions and statements from FDA officials suggest a departure from decades of practise where the agency largely deferred to expert panels.
The shift began under the Trump administration and continues under current leadership, with the FDA postponing meetings and altering the scope of advisory committee reviews. Critics allege the agency is deliberately avoiding scrutiny from outside experts, especially when decisions are politically sensitive.
“All that was transparent was that they didn’t wont to hear from anyone who disagreed with them,” said Genevieve Zuckerman, who leads the National Centre for Health Research.
The trend marks a reversal for figures like Dr. Marty Makary,the current FDA commissioner,who previously advocated for greater reliance on advisory committees.In early 2022, Makary publicly criticized the FDA’s decision to approve COVID-19 boosters for children ages 12 to 15 without consulting its Vaccine and Related Biological Products Advisory Committee, calling it “a slap in the face to science.” he posted on X (formerly Twitter) at the time, “It is indeed a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board.”
However, current FDA leadership appears to favor a different approach.Dr. Peter Tidmarsh, an FDA official, suggested the agency would be better served by advisory committees focusing on how to evaluate drugs, rather than voting on their approval or rejection. “Is this end point correct for Duchenne muscular dystrophy? That’s an important question that cuts across manny different companies,” he told KFF Health News.
This change in approach has led to canceled meetings and altered review processes.In July, FDA official Vinay Prasad canceled a planned advisory committee meeting to discuss a Duchenne muscular dystrophy drug from capricor Therapeutics. The FDA subsequently rejected the drug, and Prasad was later reassigned with reduced authority.
Experts argue that advisory committee meetings provide a crucial public forum for evaluating drug risks and benefits. “an advisory committee meeting could have worked through the drug’s risks and benefits in a calmer, public, less politicized atmosphere,” said Ramachandran.
Historically, the FDA has closely followed the recommendations of its advisory committees. A 2023 study published in JAMA Health Forum found the FDA agreed with 97% of “yes” votes and 67% of “no” votes from thes panels.
“That’s why Tidmarsh’s comments ‘come as a complete surprise,'” said Genevieve kanter, an associate professor of public policy at the University of Southern California and author of commentary accompanying the study. She added that the increased postponements of meetings this year suggest a ”strategic” effort “in terms of consolidating power in the agencies so that you are no longer accountable to outside experts or the public.”
