Advocacy group calls for greater transparency at FDA

The Center for Science in the Public Interest has published a set of recommendations in JAMA they say would help improve transparency at the US Food and Drug Administration (FDA).

Irene Park Ulrich, PharmD, MPH; and Peter Lurie, MD, MPH, of the Center for Science in the Public Interest in Washington, DC, argued that stakeholders in the public health community should use the momentum generated by Commissioner Martin Makary’s goal of “radical transparency” at FDA to advocate for greater transparency at the agency.

“Experts in government and institutional behavior agree that greater agency openness strengthens public trust, improves accountability, and fosters innovation,” the authors wrote.

Overall, the Center for Science in the Public Interest offered 32 recommendations to advance FDA transparency, which included 15 new recommendations and 17 recommendations previously made by the “Blueprint for Transparency at the US Food and Drug Administration” published in The Journal of Law, Medicine & Ethics in 2017 that were not implemented by the agency.

The focus of the recommendations ranges from transparency in premarket review of drugs and devices, expanding the disclosure of market denial communications, agency acknowledgement of investigational products and new applications, and improving processes and infrastructure within FDA.

“It is noteworthy that transparency in premarket review of drugs and devices lags behind the relative transparency provided by the premarket review processes in the food additive petition process, in which petitions are disclosed in the Federal Register within 30 days of filing, and the modified risk tobacco product review process, which requires applications to be reviewed by a public advisory committee,” Ulrich and Lurie said. “The agency appears to have successfully incorporated these enhanced transparency requirements in its regulation of food and tobacco, but both are required by statute.”

FDA should also expand their approach to publishing Complete Response Letters (CRLs) and apply it to marketing denial communications for every product type across its Centers, the authors said. In the same vein, if FDA is already publishing CRLs, it should move to acknowledge the filing of all applications for new and investigational products, they added. Ulrich and Lurie noted that, by FDA’s own admission, nearly all sponsors of new drug application and biologics license applications had announced the filings themselves. However, by making refuse-to-file letters public, the agency would be able to correct industry misstatements about products under review, they said.

Ulrich and Lurie also called for FDA to review its internal processes and infrastructure for greater transparency. “For example, minor changes in practices such as providing summary data and trend data in statutorily required annual reports would support the public’s understanding of those reports,” they wrote. “More frequent proactive disclosure of documents disclosable under the Freedom of Information Act should be considered.”

“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,” the authors concluded.

More transparency needed

The set of recommendations issued by the Center for Science in the Public Interest are a “pretty good start of a list,” Aaron Kesselheim, MD, JD, MPH, of the Program On Regulation, Therapeutics, And Law (PORTAL) group at Brigham and Women’s Hospital and Harvard Medical School, told Focus in an interview.

“I think it’s a very good list—this list is what meaningful, public health-focused regulatory transparency looks like,” he said.

Kesselheim noted he wants to see more of FDA’s datasets and analyses made public. “[T]he work of these expert scientists could be very useful for the public health,” he said.

Another addition to the recommendations would be greater transparency into the Commissioner’s National Priority Voucher (CNPV) pilot program, said Kesselheim, who was also the senior author of the 2017 “Blueprint” paper. The details of the program “would be useful to disclose, including how products qualify for this ill-defined program,” he said.

However, Kesselheim appeared skeptical that FDA would take up the recommendations.

“The current administration has given lip service to ‘radical transparency’ while doing relatively little in practice—if the administration was truly interested in pursuing meaningful, public health-focused transparency, then the options provided in this article would be a great place to start,” he said.

Janet Krommes, MD, chair of the Doctors for America FDA Task Force, told Focus that the recommendations were an “absolutely fabulous start.” Krommes said she would also like to see more data from the agency, particularly when it comes to so-called “me-too” pharmaceutical products that may perform slightly better or worse than first-in-class drugs.

“Because we’ve never had head-to-head efficacy studies in the United States, we have to sort of read the tea leaves on that, so the more information we have on those drugs, the better,” she said.

She noted that while trials on ClinicalTrials.gov are required to list two studies, and many current trials are conducting single studies, some drugs go through more than two trials. Having access to that information would be a benefit, she added.

The easiest recommendation to implement on the list would be to disclose conflicts of interest for advisory committees, Kromme said. (RELATED: GAO calls on FDA to finalize guidance on adcomm COI, Regulatory Focus 24 March 2026)

However, she emphasized that implementation of any recommendations would be a question of staffing and capacity. Krommes noted that adequate staffing has always been an issue at FDA, as the agency is “caught between a number of stakeholders” that make greater transparency difficult.

“[W]ithout the capacity to do these things, we will see a reversal in transparency. We will see less than we have in the past,” she said.

JAMA Ulrich et al.