Experts Urge 32 FDA Transparency Reforms in New JAMA Viewpoint

A pair of public health experts is calling for sweeping reforms to improve FDA’s transparency, arguing that longstanding gaps in disclosure persist despite recent progress. In a Viewpoint published 3/18 in the Journal of the American Medical Association, Irene Ulrich of the Center for Science in the Public Interest and Peter G. Lurie outline 32 recommendations aimed at making the agency’s regulatory processes more open and consistent.

The authors note that while FDA has made “important gains” in transparency — such as publishing action packages, labeling information, and postmarket safety reports —significant shortcomings remain. Of the 32 proposed reforms, 17 were first introduced in a 2017 transparency report but have yet to be implemented, while 15 are new recommendations reflecting evolving policy and technological capabilities.

The proposals vary in scope and feasibility. According to the authors:

• Three could be implemented through changes in internal agency norms
• Ten would require policy updates
• Fourteen would necessitate new regulations

None of the reforms explicitly require congressional action, although about half could benefit from legislative clarification.

A central concern raised in the article is inconsistency across FDA’s product centers. “Transparency in the premarket review of drugs and devices lags behind” other areas, such as food additives and modified-risk tobacco products, the authors write. In those categories, Congress has mandated disclosure requirements that the FDA has successfully implemented, creating a contrast with less transparent drug and device review processes.

The Viewpoint also scrutinizes FDA’s recent move to release Complete Response Letters (CRLs), documents sent to companies when a product application is not approved. While the policy shift is viewed as a step toward greater openness, Ulrich and Lurie raise procedural concerns, suggesting the agency may not have followed proper rulemaking processes in implementing the change.

They also highlight a potential contradiction: historically, FDA has not acknowledged the existence of pending or rejected applications. However, releasing CRLs effectively reveals that such applications exist, raising questions about the consistency of agency policy.

Among the most urgent reforms identified by the authors are:

• Closing the “Generally Recognized as Safe” (GRAS) loophole for food chemicals
• Publicly disclosing marketing denial communications across all product centers
• Expanding proactive release of documents already eligible under the Freedom of Information Act
• Routinely acknowledging the filing of new and investigational product applications, including investigational new drugs and new drug applications

“The public health community finds itself at odds with the current administration on multiple fronts,” the authors write, “but transparency is a rarity: a nonpartisan agenda with broad public support. Now is the time to act.” They argue that with FDA leadership signaling interest in “radical transparency,” the current moment presents a critical opportunity to enact systemic reforms that could enhance accountability, public trust, and scientific progress.