FDA Weighs Ending External Expert Panels in Drug Approvals
CBS News reports the Food and Drug Administration is considering a policy shift to curtail or eliminate the use of outside advisory committees in reviewing new drug applications. The move could speed some approvals but raises fresh concerns about transparency, conflicts of interest and public trust in an agency that relies on outside expertise to vet complex scientific claims.
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CBS News says the Food and Drug Administration is exploring a significant change to how it vets new medicines: moving away from convening external advisory committees of independent scientists, clinicians and patient representatives for many pre-approval reviews. The possible shift, described in internal discussions and interviews reported by CBS, would give FDA staff greater authority to decide whether to seek outside advice on novel or controversial applications.
Agency officials have long argued that advisory committees, which are convened for particularly complex, high-stakes or disputed cases, are advisory rather than binding. In the CBS account, proponents of the change say it could reduce duplicative meetings, speed decisions and pare back a process that can extend review timelines by weeks or months. Supporters also argue that in an era of more sophisticated internal review capabilities, the agency can reach scientifically robust conclusions without public panels on every contentious file.
Opponents — including former advisory committee members, patient advocates and transparency watchdogs — warn of the costs of sidelining outside experts. “External panels provide a public check on FDA decisions and a forum where independent scientists explain the evidence,” one former committee participant told CBS. Critics say losing that independent scrutiny risks eroding public confidence, particularly for drugs that address unmet needs or rely on surrogate endpoints and novel biomarker data.
The debate is rooted in past controversies. The 2021 approval of the Alzheimer’s drug aducanumab, which proceeded despite an advisory committee vote that largely opposed approval, remains a touchstone for critics who say the FDA’s decision-making can diverge from outside experts. Such high-profile disputes have prompted congressional inquiries, internal reviews and calls for clearer standards on when the agency should solicit external advice.
Pharmaceutical industry groups are likely to welcome any measure that shortens approval timelines, saying it would help patients access therapies sooner. Regulators point out that advisory committees have never been required for approval and that FDA professionals are bound by statutory standards and internal checks. An FDA spokesperson did not immediately respond to a request for comment on the CBS report.
Legal and ethical questions loom. Without public meetings, the agency’s rationale for leaning on or away from external input could be harder for independent observers to assess. Patient groups say that public advisory meetings are not only scientific forums but also venues where patient voices and real-world concerns become part of the record.
Congress could play a decisive role. Lawmakers who have pushed for stronger safety oversight in the wake of past controversies may call hearings or seek legislative guardrails to preserve transparency. For patients and clinicians, the practical consequences would be clear: faster access in some cases, but potentially less visible deliberation about risks, benefits and the quality of the evidence.
As the FDA weighs the balance between efficiency and public accountability, the decision will test the agency’s ability to maintain scientific rigor while preserving the trust that underpins its authority to regulate medicines that affect millions of Americans.