Top FDA Official Resigns After Barrage of Public and Political Attacks
What’s really going on here?
This article originally appeared on Trial Site News and was republished with permission.
In a development as swift as it is symbolic, Dr. Vinay Prasad has resigned from the U.S. Food and Drug Administration (FDA) less than three months after being appointed to lead the agency’s Center for Biologics Evaluation and Research (CBER), the powerful division responsible for oversight of vaccines and gene therapies.
Prasad’s departure, confirmed by the Department of Health and Human Services (HHS) late Tuesday, followed a barrage of public and political attacks, including social media campaigns by Trump-aligned activist Laura Loomer, as covered by TrialSite, and criticism from conservative figures like former Sen. Rick Santorum. A Wall Street Journal op-ed notably accused Prasad of being “a Bernie Sanders acolyte in MAHA drag.” The White House, according to CNN, had begun pressuring him to resign in recent days.
Prasad, a hematologist-oncologist and professor at UCSF, was a known skeptic of FDA drug approvals and pandemic-era public health policies. Long critical of vaccine mandates and emergency authorizations, Prasad’s appointment in May was controversial from the outset. He simultaneously held the role of FDA Chief Medical and Scientific Officer—a dual position that underscored the Trump administration’s aggressive reshaping of biomedical leadership.
A Flashpoint at Sarepta, and a Pattern of Reversals
Central to Prasad’s tumultuous tenure was his handling of Sarepta Therapeutics’ Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD) that Prasad had previously lambasted. Under his leadership, the FDA ordered a halt in shipments following a patient death in Brazil. Yet, just one day before his resignation, the agency reversed course, allowing limited use of the therapy—leaving many questioning whether Prasad was overruled or preemptively reversed himself amid mounting pressure.
He also clashed with FDA scientists over updated COVID-19 vaccine approvals, reportedly overriding internal recommendations and restricting the shots to older or immunocompromised populations—stirring concern from public health officials and biotech investors alike.
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Industry Relief, Political Confusion
Biotech markets reacted swiftly. Shares of selection biotech companies affected by FDA rejections or scrutiny under Prasad—surged in premarket trading following the news, with some analysts framing his departure as a “positive for patient choice.” The Nasdaq Biotechnology Index, which had dipped 7% on his initial appointment, began rebounding.
However, Prasad had defenders. FDA Commissioner Dr. Marty Makary praised him as “one of the greatest scientific minds of our generation,” citing reforms Prasad initiated, though few specifics have been disclosed.
Speculation, But Few Facts
The official reason—“to spend more time with family”—rings familiar in Washington circles, especially when juxtaposed with the intensity of political backlash and regulatory reversals. Did a confluence of power, money and ideology drive Prasad out of the Swamp?
While outlets like CNN and STAT suggest White House interference and intra-administration conflict, Prasad himself has remained silent. No official record yet indicates whether he resigned voluntarily or was pushed out.
The episode underscores a deeper tension within the Trump-Kennedy health agenda: reconciling populist distrust of pharmaceutical power with a need for consistent regulatory leadership. For now, the FDA finds itself leaderless in one of its most sensitive divisions—and credibility may be the next casualty.
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Bad sign.