Turmoil Mounts Under Prasad’s Leadership: WSJ
CBER is facing mounting scrutiny after its top official, director Vinay Prasad, overruled career staff and refused the review of Moderna’s application for a new mRNA flu vaccine — a move that insiders, industry executives and analysts say reflects broader disruption inside the Center. Now, we are learning that earlier reported conflicts with staff have allegedly become more severe.
According to a report in The Wall Street Journal, Prasad rejected Moderna’s filing earlier this month, arguing that the company’s Phase 3 trial was inadequate. The decision came despite prior FDA sign-off on the study design and internal pushback from agency reviewers. In a January meeting that reportedly lasted about an hour, career staff urged Prasad not to refuse the application outright, contending that concerns about the trial could be addressed during the standard review process. Prasad proceeded anyway.
The episode has heightened concerns about what industry sources describe as a pattern of regulatory reversals under Prasad, the Journal reports. At least nine companies — many developing treatments for rare or hard-to-treat diseases — have experienced abrupt shifts in regulatory posture in recent months, according to people familiar with the matter.
Prasad has reportedly taken direct involvement in multiple high-profile decisions and has signaled internally that he prefers issuing “refuse-to-file” letters rather than conducting full reviews that could culminate in formal rejections. Former FDA officials and agency observers say that approach departs from long-standing practice and could expose the agency to greater litigation risk, according to the Journal. During the January meeting on Moderna’s application, staff reportedly warned about legal vulnerability, but Prasad indicated he was unconcerned about potential lawsuits.
Adding to the controversy, Prasad has faced multiple internal personnel complaints, according to the Journal, and has made public statements — including social media posts and internal emails — that have drawn criticism from some FDA staff. “Prasad is facing several personnel complaints filed against him, including some that involve sexual harassment, retaliation against subordinates, and verbally berating staff, people familiar with the matter said,” the Journal reports. “He lives in the San Francisco area and usually commutes to the FDA’s Maryland headquarters for several days every two weeks. Taxpayers pay for his commute, which, according to one estimate, costs around $65,000 a year…”
The latest reports of turmoil add to earlier concerns raised in an 11/52025 Medpage Investigative Roundup that highlighted key findings in a STAT report (subscription required) about chaos under Prasad's leadership. The report indicated that several CBER employees had also filed human resources complaints about the director’s management style and practices. It said employees told STAT anonymously that Prasad is not a transparent or communicative manager, and his main leadership goal seems to be adding more scrutiny to vaccines.