Healing Our De-Commissioned FDA

From HealthAffairs.

By Aaron S. Kesselheim and Jerry Avorn.

At a time of rapidly developing new medications and growing public health challenges, there is now no official leadership in place at the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention, and the Office of the Surgeon General. Marty Makary's legacy will be that he undercut many of the key principles that had made the agency one of the most important public health institutions in the world.

SUMMARY

In this Forefront piece published the day of FDA Commissioner Marty Makary's resignation, Kesselheim and Avorn assess the damage done to the FDA during his tenure and argue that the resulting leadership vacuum — which now extends simultaneously to the FDA, the CDC, and the Office of the Surgeon General — presents an opportunity, not merely a crisis. They call on the Senate to insist on competence over ideology in choosing the next FDA commissioner, and argue that a return to science-based decision-making, genuine transparency, and public accountability is both possible and urgently necessary. The piece is notable for being published on the same day Makary resigned, making it one of the most immediate assessments of his legacy by two of the nation's leading pharmaceutical policy researchers.

BACKGROUND

When Makary was confirmed as FDA Commissioner just over a year before his resignation, he invoked what the authors characterize as the myth that the FDA is too slow and bureaucratically entangled — this despite the agency's worldwide reputation for rigor and for moving products through its processes effectively. He promised "radical transparency" and modernization. The authors acknowledge there are areas where the FDA could improve its processes, but argue that most of Makary's positive "reforms" barely made it past press conferences. The agency he leaves behind is, in their assessment, weaker, rudderless, and less respected than at any point in the last 50 years.

KEY FINDINGS

Science subordinated to political pressure. Makary ended the time-honored process of inviting external scientists to publicly assess new medications through advisory committee meetings — a cornerstone of transparent, peer-reviewed FDA decision-making. These were replaced by occasional ad hoc groups of less authoritative figures, often hand-picked to ratify predetermined decisions. Scientifically indefensible decisions followed: Makary announced that the cancer drug leucovorin would be approved to treat autism despite the absence of convincing efficacy data for that indication. A vaccine application was rejected on what the authors characterize as clearly political rather than scientific grounds. One of Makary's hand-picked leaders announced the FDA had found at least 10 COVID vaccine-induced deaths — a claim the authors state appears to be untrue.

A new fast-track program without criteria. Makary introduced the FDA Commissioner's National Priority Voucher program, purportedly designed to approve selected new medications in just one to two months — far too quickly, the authors argue, to allow for adequate review of effectiveness or safety. No clear guidelines governed which drugs could receive this designation; nearly two dozen were announced in the program's first year without clarity about selection criteria, potentially opening the door to backroom deals or political pressure.

Leadership chaos and personnel decimation. Scientists across the FDA's most senior positions quit or were dismissed and were sometimes replaced by unqualified candidates. One key leader was fired, then rehired, then quit. Another resigned after an ethical inquiry within just a few months. Combined with massive DOGE-driven staff cutbacks, these disruptions left agency-wide personnel capacity and morale at all-time lows. The agency is now temporarily being run by someone with no scientific training who recently served as a lawyer representing a major food company's interests.

The irony of Makary's exit. The proximate cause of Makary's resignation was, ironically, a science-driven position: he opposed an administration-backed decision to approve flavored e-cigarettes, which would make addictive products more appealing including to children. RFK Jr.'s main spokesperson cited the same issue when he resigned a day later.

PDUFA reauthorization as the next critical test. The authors identify the upcoming reauthorization of the user-fee funding system — renewed by Congress every five years and accounting for a significant portion of the FDA's budget — as the most consequential near-term challenge facing the next commissioner. Managing that reauthorization and its many stakeholders will require careful, sober leadership that is currently absent.

IMPLICATIONS

The authors argue that the current leadership vacuum offers a genuine opportunity for reset. A new, less bombastic and less ideological commissioner could return the FDA to its foundational principles: science-based decision-making, genuine transparency, and public accountability. They call on the Senate to end its rubber-stamping of health-sector appointments made on the basis of ideology or loyalty rather than competence, pointing to the long history of FDA commissioners — generally appointed on a nonpartisan basis — who made critical decisions based on evidence rather than politics. The authors conclude: "It's not too late for the next commissioner to revive and honor that tradition. The nation's health requires nothing less."

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