JAMA Examines FDA’s Move Away From Advisory Committees

A new analysis published in JAMA Health Forum examines FDA’s quiet but significant shift in how it seeks outside scientific advice, raising legal and credibility concerns about the agency’s decision-making process. In the article, C. Joseph Ross Daval and Aaron S. Kesselheim contend that FDA has scaled back its use of longstanding advisory committees while convening a new series of “expert panels” that they say lack the procedural safeguards and independence historically associated with formal advisory bodies. Daval and Kesselheim are both part of Harvard Medical School’s Program On Regulation, Therapeutics, and Law.

Over the past year, FDA has convened fewer traditional advisory committee meetings than at any recent point in its history. Instead, the agency has held five expert panels addressing topics including antidepressant use in pregnancy, hormone therapy and menopause, talc additives, testosterone therapy in men, and infant formula.

According to the authors, these panels differ in key structural and procedural respects from standing advisory committees. Unlike advisory committees — whose members typically serve ongoing terms, deliberate collectively, and vote on specific regulatory questions — the expert panels consist of individuals invited for a single session. Panelists offer short, sequential presentations and are not asked to deliberate as a group or issue formal recommendations.

The authors suggest that many panelists appear to have been selected based on views aligned with policy positions associated with the “Make America Healthy Again” movement. As a result, they argue, FDA may be seeking validation for decisions already made rather than using outside experts to shape policy.

They note the shift became especially visible during a 7/2025 panel on hormone therapy (HT) for menopause. Traditionally, issues involving reproductive drugs might be reviewed by a standing body such as the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee. Instead, FDA convened a two-hour expert panel session, and panelists did not deliberate collectively or respond to formal regulatory questions from the agency.

In November, FDA commissioner Marty Makary announced changes to labeling on hormone replacement therapy (HRT) products, including removal of Boxed Warnings. At a press conference, he said the move was “based on” both the agency’s review of evidence and input from the expert panel — even though the panel had not voted or issued a formal recommendation. The authors argue that this approach allows the FDA to cite expert input while avoiding the unpredictability of an independent advisory committee vote.

The authors raise the possibility that the new panels may implicate the Federal Advisory Committee Act (FACA), which governs how federal agencies obtain advice from external groups. Potential plaintiffs could challenge panel composition or argue that FDA has unlawfully curtailed required advisory committee meetings, particularly in areas such as new drug approvals where statutes mandate regular consultation, they contend.

Beyond legal risks, the article warns of reputational consequences. Advisory committees have long served not only as a source of scientific expertise but also as a public demonstration of the FDA’s commitment to independent, evidence-based decision-making. Replacing those committees with shorter, less formal expert panels may erode public trust, the authors say, particularly if panels are perceived as reinforcing predetermined outcomes or political messaging.

“In the case of HRT, changes to the previous labels may be necessary,” the authors write. “But instead of supporting its choice by soliciting clear recommendations from a body of independent experts, the FDA unnecessarily muddied the waters.”

The article concludes that the agency’s evolving approach signals a broader tension between scientific process and political influence, raising questions about whether FDA is prioritizing constituency signaling over the procedural tools traditionally used to safeguard regulatory integrity.