Now is the time to act on 32 FDA transparency reforms, experts say in JAMA

In a Viewpoint published today in the Journal of the American Medical Association, Dr. Irene Ulrich, senior policy scientist at Center for Science in the Public Interest, and CSPI President Dr. Peter G. Lurie identify persistent gaps in the agency's transparency practices, despite important gains in recent decades, including mandatory online publication of action packages, labeling, and post market safety reports.

In their paper, the authors outline 32 specific recommendations to improve FDA transparency: 17 carry over from a 2017 transparency report that remain unimplemented, and 15 are new.

Of the 32 recommendations in the Viewpoint, three could be achieved through changes in internal norms, 10 through policy updates, and 14 through regulation. None definitively requires congressional action, though 16 may benefit from clarification from Congress.

A central observation, they note, is the inconsistency in transparency practices across FDA's product centers.

"Transparency in the premarket review of drugs and devices lags behind the relative openness of the premarket review processes for [certain] food additives and modified risk tobacco products," they write. These are two areas where Congress has mandated some level of disclosure and where FDA has successfully implemented those requirements.

FDA's recent decision to release Complete Response Letters - communications sent to sponsors when a product is not approved - marks a notable step forward. But the authors argue that the agency may not have adhered to proper procedure in promulgating this change. And the release of CRLs calls into question FDA's longstanding practice of not acknowledging application filings for new and investigational products until they are approved, because the release of a CRL discloses the existence of an unapproved application.

The current moment offers a uniquely strong occasion for systemic reform, particularly given FDA leadership's stated commitment to "radical transparency." Among the authors' priority recommendations are closing the Generally Recognized as Safe, or GRAS, loophole for food chemicals; public disclosure of marketing denial communications, applied consistently across product centers; greater proactive release of documents already eligible for disclosure under FOIA; and routine public acknowledgement of the filing of applications for new and investigational products (e.g., Investigational New Drug applications and New Drug Applications) and Refuse to File letters.

Ulrich and Lurie emphasize that the public is strongly aligned with these aims.

"A 2022 survey assessing public opinion on 10 of these recommendations found that all measures received support-and, in many cases, overwhelming support - across political affiliations," they write.

Their conclusion is clear: "The public health community finds itself at odds with the current administration on multiple fronts, but transparency is a rarity: a nonpartisan agenda with broad public support. Now is the time to act."

Read a detailed report on these transparency recommendations here.

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Tags

• Food and Drug Administration
• Transparency

Topics

• CSPI
• Government Accountability

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