Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Energy & Commerce committee ranking member Diana DeGette.
Journal articles penned by former FDA officials do not constitute official agency policy, acting director Kyle Diamantas has clarified.
This was revealed during a House Energy & Commerce committee hearing Monday by ranking member Diana DeGette (D-CO), who wrote to the FDA earlier this year questioning the agency’s failure to abide by its own established practices for releasing guidelines. In her opening statement, she blasted former Commissioner Marty Makary for his “shoot-from-the-hip approach to policy” that kept drugmakers and researchers in the dark.
Makary and other agency officials, DeGette continued, “made major policy announcements through journal articles, press releases and even podcasts, circumventing FDA’s policymaking processes and making it so researchers did not know what was official policy.”
It’s a concern that has been shared by industry, particularly following the departures of Makary and one of his top lieutenants, Vinay Prasad, former director of the Center for Biologics Evaluation and Research. The former commissioner stepped down in May while Prasad took an earlier exit at the end of April.
“We got a lot of questions, especially after both leaders left FDA,” Ritu Nalubola, director of life sciences and healthtech at Marwood Group, said during a panel discussion at the BIO International Convention in San Diego last month. “If the policy that was announced in a journal article by two individuals who are no longer at the agency, what does this mean? Is it in fact FDA policy?”
As former associate commissioner for policy at FDA, Nalubola added that she had published with other agency leaders during her 25 years of service. “Typically when FDA scientists publish articles, there’s a disclaimer that says it’s not necessarily representative of the FDA policy, but in fact, in this case, it was, this is the policy of the FDA,” she described. “[So I was] more than surprised to see how FDA was able to make policy in this in this manner.”
In December last year, for instance, Makary and Prasad penned an article for the Journal of the American Medical Association outlining the requirement of randomized controlled trials for CAR T therapies, alongside other new evidentiary standards.
A month earlier, Makary and Prasad wrote for the New England Journal of Medicine about a “plausible mechanism pathway” for rare genetic diseases, opening approvals for therapies with a clear biologic rationale to address a specific condition—even without a randomized trial.
In May, the FDA confirmed that Makary’s policies will live on even after his tenure, noting “reforms initiated under the previous commissioner continue to move forward.” But in his response letter to DeGette, Diamantas addressed these two publications specifically. About the JAMA paper, he clarified that “FDA does not consider this article to be an FDA guidance document” and that it “does not set forth expectations for industry.”
The the acting director similarly made it clear in his response that the NEJM article “did not communicate FDA policy or interpretation of a regulatory issue.” The FDA has since released draft guidance for the plausible mechanism pathway, which Diamantas noted “went through the typical Agency development, review, and clearance process.”
DeGette appeared satisfied with Diamantas’ response and performance as acting director so far. “Luckily, there is evidence that with Makary gone, things are slowly improving,” she said in her opening address, noting that Diamantas “has shown every indication that he will empower career experts to do their jobs.”
Agency employees seem to share a positive view of Diamantas. Scott Faber, senior vice president of the Environmental Working Group, told STAT News in May that Diamantas, who is also the FDA’s top food executive, has “earned the respect of career staff” and other shareholders.
“Kyle is someone who listens to everyone,” Faber added.
Editor’s note: This story contains reporting contributed by Jef Akst from BIO 2026.
