FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications. This type of “fiat” decision-making, as multiple regulatory experts have called it, is also bleeding into the agency’s policymaking.
When Center for Biologics Evaluation and Research Director Vinay Prasad last month personally sent Moderna a refusal-to-file letter for its mRNA-based flu vaccine, it highlighted a growing concern among industry watchers that the FDA is not listening to its expert advisors or even its own staff when making decisions—or when issuing new policies.
Steven Grossman, president of policy and regulatory consulting firm HPS Group, decried the Moderna refusal, calling it a “fiat” decision. Indeed, Prasad overruled Office of Vaccines Research and Review director David Kaslow and other FDA staffers, who had deemed Moderna’s application worthy of review, according to STAT News.
That move, Grossman said, undermines the FDA’s integrity and reputation. “[It] is bad for process, bad for fairness, bad for investment, and bad for progress in public health.”
Grossman is not the first regulatory expert to use the word “fiat” in relation to the FDA’s current practices, and specifically with regard to Prasad. In November, the CBER chief claimed in an internal memo that COVID-19 shots had caused the deaths of “at least” 10 children. Because of this, FDA frameworks around vaccines were going to be changed, Prasad said.
It was as if he was issuing a decree “by fiat,” Dorit Reiss, a professor at UC Law San Francisco who specializes in vaccines law and policy, told BioSpace at the time.
Prasad’s latest fiat decision on Moderna’s flu vaccine was ultimately overruled after FDA Commissioner Marty Makary had a chat with President Donald Trump. The agency held a Type A meeting with Moderna, resulting in an amended filing that the FDA promptly accepted, promising a decision by August 5.
The correction of course wasn’t enough to pull attention away from Prasad’s conduct, however. Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, told BioSpace, “It’s almost as though he had a temper tantrum and took all the toys off the table and said, ‘I’m going to handle this because I know what I’m doing, and you guys are all idiots,’” referring to the members of the review team for Moderna’s application.
“That just shows how naive he is,” Pitts continued. “It also sends a dangerous message to his staff that they’re not really being treated as the highly trained and very devoted professionals that they are, by basically this creep who is a political animal and who does not know what he’s doing.”
In another example that attracted widespread media coverage, Prasad reportedly bigfooted Nicole Verdun, the former director of the office that reviews cell and gene therapies, and her deputy, Rachael Anatol, in relation to the July 2025 rejection of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy deramiocel, which the company was proposing for Duchenne muscular dystrophy cardiomyopathy.
Pitts raised the concern that Prasad, who is now under investigation for creating a toxic work environment, berating staff and retaliating against reviewers who questioned his decisions, could do more harm with his “dangerous” mindset. “Unfortunately, you begin to think you know everything, and that you’re always the smartest person in the room, and that you’re always right,” Pitts said. “That’s never a good thing, least of all in an organization that is filled with really smart people [who] understand in great detail and depth what they’re talking about.”
The FDA has moved away from relying on that expertise in other ways as well. In 2025, the agency went against the recommendations of its advisory committees 43% of the time. The agency also held fewer advisory committees overall, and started a new initiative of expert panels, which were heavily criticized for being stacked with people who supported a particular viewpoint and for lacking nuance.
“FDA has earned its stellar global reputation over the last century by being reliable in all the right ways: science-based decision-making, a willingness to consider various points of view, a commitment to process, and a bottom-up (expert-driven) approach to developing policies and making product decisions,” Grossman wrote in Medpage Today last week. “Many times, the agency has welcomed new leadership with new priorities -- and become better as a result. But regardless of who came and went in FDA leadership, this basic framework remained in place. That was the case until recently.”
Beyond individual FDA decisions, the agency has begun issuing guidance in a way that has many on high alert, including by publishing editorials written by Makary and Prasad in medical journals. Additional details have then been churned out in relatively short order.
When Harpreet Singh was a division director of oncology at the FDA, draft guidances took “several months” to prepare, she recently told BioSpace. By contrast, Makary and Prasad conceptualized the FDA’s new Plausible Mechanism Pathway in a New England Journal of Medicine article in November 2025 and published draft guidance less than three months later. Similarly, the agency teased its one-trial policy shift in an interview with STAT News in December and laid out further details in the NEJM on February 18.
“I think you could argue that though these timelines are accelerated, they’re probably being put out with less broad input than prior guidances,” Singh said.
“Another thing that stands out about this [one trial] manuscript—even the guidance that came out—is how small the circle is,” she said. “Who’s putting these thoughts together? Are they getting broad consensus? Part of what took so long in a more classic FDA process . . . was that there were several layers of consensus building that we needed to gather before publishing something publicly.”
