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# Health Affairs Commentary Says Makary Left FDA ‘Weaker’
- URL: https://www.fdaweb.com/health-affairs-commentary-says-makary-left-fda-weaker/
- Published: 2026-05-18T12:00:00.000Z
- Updated: 2026-09-14T13:39:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161162

Two prominent drug-policy scholars sharply criticized former FDA commissioner **Marty Makar**y in a commentary published Monday, arguing that his tenure weakened the agency and undermined longstanding scientific and regulatory norms at the agency. In an article published by [*Health Affairs*](https://www.healthaffairs.org/?utm%5Fsource=chatgpt.com), Aaron Kesselheim and Jerry Avorn said Makary’s resignation last week left FDA “weaker, rudderless, and less respected than it has been in the last 50 years.”

The authors wrote that the departures of senior officials at FDA, the Centers for Disease Control and Prevention and the Office of the Surgeon General have created what they described as an unprecedented leadership vacuum across federal health agencies. They also pointed to the recent exit of a senior spokesperson for HHS secretary **Robert F. Kennedy Jr**.

Kesselheim, a professor at Harvard Medical School, and Avorn, a physician and professor at Harvard Medical School, accused Makary of abandoning core FDA principles, including adherence to scientific review standards, transparent regulatory processes, and protection of public trust in the agency. “When Makary, a surgeon, was confirmed as FDA commissioner just over a year ago, he invoked the myth that FDA is too slow and entangled in its own bureaucracy,” the authors wrote. While acknowledging that some reforms were needed, they said many of Makary’s promised modernization efforts failed to materialize.

The article criticized Makary for scaling back FDA’s use of outside advisory committees, alleging that the agency instead relied on “ad hoc groups of less authoritative figures” selected to support predetermined decisions.

The authors also accused Makary of allowing politics to influence regulatory actions, citing his public statements about Covid-19 vaccine safety investigations and what they described as arbitrary vaccine review decisions. They further criticized a reported plan to approve leucovorin for autism despite limited supporting evidence.

At the same time, the commentary said Makary’s reported opposition to an administration-backed proposal to authorize flavored e-cigarettes may have contributed to his departure. The authors described that position as a rare example of Makary taking a “science-driven stand.”

The article also took aim at Makary’s “FDA Commissioner’s National Priority Voucher” program, which sought to accelerate reviews of selected therapies. The authors argued the initiative lacked clear eligibility criteria and risked politicizing approval decisions by allowing certain products to receive reviews within one or two months.

The commentary further described extensive staff turnover and morale problems within the agency during Makary’s tenure, including the departure or dismissal of senior scientists and personnel reductions tied to broader federal workforce cuts.

Kesselheim and Avorn said the leadership transition could present an opportunity for FDA to return to “science-based decision making, genuine transparency, and public accountability,” particularly as Congress prepares for the next reauthorization of the agency’s user-fee programs that fund much of its drug and device review operations.

The authors urged lawmakers to prioritize scientific competence over ideology in future health agency appointments, arguing that FDA’s credibility depends on evidence-based and predictable regulatory decision-making.