FDA Commissioner Marty Makary was called to the White House shortly after the agency declined to review Moderna’s investigational mRNA-based flu vaccine. This decision has intensified ongoing tensions at the FDA, drawing attention from President Donald Trump and leading to increased scrutiny of senior officials.
According to Politico, President Trump “expressed frustration” with Makary over how the FDA is handling vaccine issues, referencing information from sources familiar with a recent meeting between the two. The refusal to review Moderna’s application followed intervention by Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), who overruled David Kaslow, review director at the Office of Vaccines Research. STAT News reported that Kaslow had written an internal memo opposing Prasad’s move.
After Makary’s discussion with Trump, a Type A meeting between Moderna and the FDA was scheduled, which “gave [the FDA] a public way to save face,” Politico cited. An amended filing was then accepted by the agency, which promised a decision on Moderna's mRNA-1010 flu shot by August 5.
The controversy surrounding Prasad has grown since he became CBER director in May 2025. Jama Pitman of Rose Hill Life Sciences commented on Prasad’s history: “He’s been there, he’s not been there, he’s come back.” In June 2025, Prasad reportedly clashed with Nicole Verdun over Capricor Therapeutics’ gene therapy application for Duchenne muscular dystrophy. This dispute allegedly led to Verdun leaving her post later that month.
Prasad also briefly left the FDA in July 2025 after controversy involving Sarepta Therapeutics’ Elevidys gene therapy but returned ten days later at what HHS spokesperson Andrew Nixon described as “the FDA’s request.” Politico reported that his departure was prompted by the White House but that Makary played a key role in bringing him back.
In November 2025, former CDER Director George Tidmarsh resigned and told The New York Times that he found working conditions at the agency toxic—a situation he attributed to Prasad.
Prasad drew further attention when he personally signed Moderna’s refuse-to-file letter instead of delegating it as usual. Peter Pitts, president of the Center for Medicine in the Public Interest and former associate commissioner at the FDA, said Prasad was “both naive and dangerous” regarding this action. Pitts added: “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.’”
The Wall Street Journal reported that Prasad is facing several internal complaints including allegations of sexual harassment and retaliation against staff members. In November 2025, Prasad sent an internal memo stating COVID-19 vaccines caused deaths among children and indicated those who disagreed could resign.
Prasad has also intervened in areas outside his jurisdiction; recently rejecting Disc Medicine's bitopertin drug application despite its review falling under another office.
Jama Pitman remarked: “This is becoming a thing now with him. It’s a little perplexing…because it’s not a good look for the agency; it’s not a good look for him.”
Senator Bill Cassidy (R-LA), chair of the Senate Health Committee, released a report criticizing what he called "black box" processes within FDA reviews. Pitts urged Makary to act: “[Prasad] single-handedly is setting back President Trump’s healthcare agenda and leaving the United States at great risk for having increasingly high rates of nonvaccinated men, women and children,” adding: “This guy needs to be fired.”
Leadership instability continues at both CDER and CDC—five different leaders have headed CDER over twelve months—with calls from Congress for reform amid upcoming midterm elections.
Richard Pazdur was appointed CDER director in November 2025 in hopes of stabilizing operations but retired soon after due to disagreements about reducing clinical trial requirements for new drugs. Pazdur told The Wall Street Journal: “All of a sudden I was given a press release with a quotation by myself written in it…and asked just to agree.” He criticized current leadership practices: under Makary's tenure “this wall between commissioner’s office and review staff has been breached.”
An HHS spokesperson defended Makary saying he leads "with a profound sense of urgency in delivering cures," emphasizing decisions are based on recommendations from career scientists.
The situation raises questions about stability among senior officials within HHS as repeated demands for change continue ahead of elections.
