FDA Vaccine Chief Resigns After Political Backlash and Gene Therapy Disputes

Dr. Vinay Prasad, the FDA vaccine chief, has stepped down just three months after assuming the role, following mounting controversy over his leadership style, political views, and decisions surrounding gene therapy approvals.

The Department of Health and Human Services confirmed late Tuesday that Prasad was resigning “to spend more time with his family,” though insiders told the Associated Press that he was effectively ousted due to internal tension and public criticism.

Prasad’s Contrarian Views Stirred Controversy

Before joining the FDA in May, Prasad was a vocal critic of the agency during his time as a researcher at the University of California, San Francisco. He frequently questioned the FDA’s handling of drug and vaccine approvals, particularly during the COVID-19 pandemic. His views aligned closely with those of current FDA Commissioner Marty Makary, who praised Prasad’s intellect and independent stance.

However, Prasad’s past remarks resurfaced in recent weeks, drawing backlash from conservative circles. Activist Laura Loomer criticized him for expressing support for Senator Bernie Sanders and previously opposing President Trump, prompting online outrage.

Gene Therapy Decisions Sparked FDA Firestorm

The final blow to Prasad’s short tenure came after his controversial handling of the only FDA-approved gene therapy for Duchenne muscular dystrophy, produced by Sarepta Therapeutics. After multiple patient deaths, Prasad ordered a temporary halt to the therapy’s distribution—an action that enraged patient advocacy groups and conservative commentators.

Under pressure from families and political allies, the FDA reversed the suspension and resumed distribution of the therapy on Monday.

Prasad has long questioned Sarepta’s drugs and has criticized the FDA for approving treatments he viewed as lacking sufficient clinical evidence. He also denied approval to three new gene therapy applications from small biotech companies earlier this month.

A Shift from Previous FDA Leadership

Prasad succeeded Dr. Peter Marks, who oversaw a wave of gene therapy approvals, including the first COVID-19 vaccines. While Marks championed innovation and flexibility, Prasad took a stricter stance—one that clashed with the Trump administration’s pro-approval posture and its support for the “Right to Try” law, which advocates expanded access to unproven treatments.

“How did this Trump-hating Bernie Bro get into the Trump admin???” – Laura Loomer on X

FDA Vaccine Chief Resignation Highlights Growing Political Tensions

The FDA vaccine chief resignation 2025 highlights the growing politicization of public health leadership. Prasad’s departure leaves a gap at a time when the FDA faces heightened scrutiny over drug safety, gene therapy approvals, and political interference.

The Biden administration has not yet named a replacement. Meanwhile, Prasad’s departure is seen as a victory for conservative groups pushing for looser regulations and faster access to experimental treatments.

Source: ABC News