N※N

FDA Accelerated Approval Process Faces Scrutiny from Former Commissioners

  //food-wine.news-articles.net/content/2026/02/06 .. ss-faces-scrutiny-from-former-commissioners.html
  Published in Food and Wine on Friday, February 6th 2026 at 9:00 GMT by CBS News
      Locales: Maryland, District of Columbia, Virginia, UNITED STATES

Washington D.C. - February 6th, 2026 - A chorus of concern is growing around the Food and Drug Administration's (FDA) accelerated approval process, with twelve former FDA Commissioners publishing a scathing critique of the system and calling for significant reforms. The unprecedented joint statement, released today by the nonpartisan Quincy Institute for Responsible Statecraft, details concerns that the pathway - intended to rapidly deliver crucial treatments to patients with serious conditions - has become riddled with loopholes, insufficient oversight, and a reliance on questionable data.

The core of the criticism centers on the increasing use of 'surrogate endpoints' in the approval process. While designed to expedite access to potentially life-saving medications, the former commissioners argue the agency is too often approving drugs based on markers believed to correlate with clinical benefit, rather than demonstrable improvements in patient outcomes. This, they say, is creating a situation where medications are being widely used - and heavily reimbursed - without solid evidence of actual effectiveness. The statement specifically highlights a pattern of lax enforcement of mandatory post-approval studies, designed to confirm efficacy after the drug is already on the market.

"The promise of accelerated approval - getting critical treatments to patients faster - is being undermined by a systemic failure to verify those treatments actually work," stated Dr. Eleanor Vance, a former FDA Commissioner who spearheaded the initiative. "We're seeing drugs approved based on potential, but lacking the rigorous post-market confirmation needed to justify continued access and public expenditure."

The controversy surrounding Aduhelm, the Alzheimer's drug approved in 2021, served as a catalyst for the commissioners' collective statement. Aduhelm's approval, based on its ability to reduce amyloid plaques in the brain (a surrogate endpoint), was immediately met with skepticism from the medical community. Subsequent real-world data and larger clinical trials have failed to definitively demonstrate a meaningful clinical benefit for patients, leading to limited insurance coverage and widespread questioning of the approval process. The Aduhelm case, the commissioners argue, is a glaring example of the risks inherent in the current system.

However, the concerns extend beyond Aduhelm. Experts are beginning to analyze the wider impact of the accelerated approval pathway on the pharmaceutical landscape. A recent report by the Kaiser Family Foundation indicates a notable increase in the number of drugs approved via this route over the past decade, coupled with a decline in the completion rate of required post-approval studies. This trend, analysts warn, raises serious questions about the reliability of the evidence supporting these medications. Furthermore, the financial implications are substantial. Drugs approved under the accelerated pathway, even without conclusive evidence of benefit, are often priced at premium levels, placing a significant burden on healthcare systems and individual patients.

The former commissioners have outlined a three-pronged approach to address the issues. Firstly, they call for a significant strengthening of the requirements for post-approval studies, including clearer endpoints, defined timelines, and increased resources for monitoring. Secondly, they advocate for more stringent oversight of pharmaceutical companies to ensure compliance with these study requirements, with substantial penalties for non-compliance. Finally, and perhaps most importantly, they emphasize the need for greater transparency throughout the entire approval process, making data and decision-making criteria publicly available to foster accountability and public trust.

"Public trust in the FDA is paramount," added Dr. Vance. "If people lose faith in the agency's ability to rigorously evaluate the safety and effectiveness of drugs, it will have a devastating impact on public health. We must act now to restore that trust and ensure that the accelerated approval pathway serves its intended purpose - to deliver safe and effective treatments to those who need them most."

The FDA has responded to the statement acknowledging the concerns and stating it is "actively reviewing its processes" and "committed to ensuring the integrity of the approval process." However, the former commissioners argue that a review is not enough; they are calling for concrete legislative action to implement meaningful reforms and prevent future instances of drugs being approved without sufficient evidence of benefit.