The U.S. Food and Drug Administration (FDA) is facing scrutiny from regulatory experts and industry observers over its recent decision-making processes, particularly following a high-profile refusal to review Moderna’s mRNA-based flu vaccine application. The action was taken personally by Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, who overruled other FDA staff members, including Office of Vaccines Research and Review director David Kaslow.
Steven Grossman, president of the policy and regulatory consulting firm HPS Group, criticized the move as a “fiat” decision. “[It] is bad for process, bad for fairness, bad for investment, and bad for progress in public health,” Grossman said.
Grossman is not alone in his concerns about unilateral actions at the agency. In November, Prasad stated in an internal memo that COVID-19 vaccines had caused the deaths of “at least” 10 children and announced changes to FDA frameworks around vaccines. Dorit Reiss, a professor at UC Law San Francisco specializing in vaccine law and policy, commented to BioSpace that it appeared Prasad was issuing decisions “by fiat.”
After intervention by FDA Commissioner Marty Makary—who spoke with President Donald Trump—the agency reversed course on Moderna’s application just eight days after issuing the refusal letter. A Type A meeting led to an amended filing from Moderna that the FDA accepted, promising a decision by August 5.
Despite this reversal, questions remain about Prasad’s conduct. 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 those involved in reviewing 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.”
Prasad has reportedly been under investigation for creating a toxic work environment at CBER. Pitts expressed concern that such leadership could undermine morale among expert reviewers: “Unfortunately, you begin to think you know everything... 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.”
Another incident cited involved Prasad overruling Nicole Verdun—then director of the office reviewing cell and gene therapies—and her deputy Rachael Anatol during Capricor Therapeutics’ failed attempt to secure approval for its Duchenne muscular dystrophy cell therapy deramiocel.
Concerns extend beyond individual cases. In 2025, the FDA went against its advisory committees’ recommendations 43% of the time while holding fewer committee meetings overall. The agency also began using new expert panels criticized for lack of diversity in viewpoints.
“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 recently. He added that this tradition remained intact through many leadership changes until now.
The speed at which new guidance has been issued has also raised alarms among former FDA officials like Harpreet Singh. She noted draft guidances once took several months but recent initiatives—such as Makary and Prasad's Plausible Mechanism Pathway—have moved from journal article concepts to draft guidance publication within three months or less.
“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.
She added: “Another thing that stands out about this [one trial] manuscript—even the guidance that came out—is how small the circle is... Part of what took so long in a more classic FDA process . . . was that there were several layers of consensus building.”
In summary, experts point toward an increasingly centralized decision-making process at the FDA under current leadership—a shift some say risks undermining both internal expertise and public trust.
