FDA Considers Scaling Back Independent Review of New Drugs
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Washington D.C. – In a move that’s raising eyebrows among public health experts, the food and Drug Administration is signaling a potential shift away from its long-standing practice of utilizing independent advisory committees to review new drug applications. The agency’s potential pullback, first reported by KFF Health News on September 12th, could considerably alter the landscape of drug approval oversight in the United States.
Agency Cites Redundancy, Burden
Dr. George Tidmarsh, Director of the FDA’s Center for Drug Evaluation and Research, has indicated the agency believes convening these advisory committees for each individual drug approval is becoming “redundant” and places an unnecessary burden on both regulators and pharmaceutical companies. The committees, comprised of external experts, have historically provided crucial independent assessments of a drug’s safety and efficacy.
Critics Warn of Reduced Transparency and Expertise
However, the proposed change is facing strong opposition from a wide range of stakeholders, including former FDA officials, academic leaders, and public health advocates.These critics argue that advisory meetings are invaluable for informing agency decisions and providing a vital layer of transparency to the public. They fear a reduction in independent review could compromise the rigor of the drug approval process.
“It’s hard to follow” Dr. Tidmarsh’s reasoning, stated former FDA commissioner Robert Califf, MD, in an interview with KFF Health News. “It’s extremely useful for people inside [the] FDA to find out what other experts think before they make their final decisions. And it’s critically important to do that in a way that enables the public to understand the points of view.”
The FDA’s advisory committees were formally established by law in 1972, serving as a critical check on agency decisions, especially for drugs considered controversial or in high demand. Data reveals a notable decrease in the number of meetings held under the leadership of Commissioner Marty Makary, MD.Only seven advisory committee meetings have been scheduled for 2025, a dramatic drop compared to the 22 meetings convened during the same period in 2024. This trend underscores the agency’s apparent move towards a less reliant approach on external expert input.
This is a developing story. World-Today-News.com will continue to provide updates as they become available.
