FDA Official Prasad Steps Down After Sarepta Controversy

The Controversial Exit of Vinay Prasad from the FDA

Vinay Prasad, a prominent figure at the U.S. Food and Drug Administration (FDA), left his position after facing intense scrutiny from conservative media and activists over his decisions regarding gene therapy treatments. His departure came as a result of significant pressure from figures like Laura Loomer and Rick Santorum, who criticized his handling of Sarepta Therapeutics Inc.’s gene therapy for Duchenne muscular dystrophy, known as Elevidys.

Prasad, along with FDA Commissioner Marty Makary, had asked Sarepta to halt the distribution of Elevidys following three deaths linked to the company’s gene therapies. Initially, Sarepta refused, but eventually complied, which led to widespread backlash that the agency had overstepped its authority.

Conservative Backlash and Political Pressure

Laura Loomer, a far-right activist, was among the most vocal critics, calling for Prasad's removal on social media. She labeled him a “leftist saboteur undermining Trump’s FDA” and demanded his immediate dismissal. Meanwhile, Rick Santorum, a former U.S. Senator, reached out to Trump administration officials expressing concerns about the FDA’s approach to Sarepta’s gene therapy.

The Wall Street Journal’s editorial board criticized the FDA’s decision to suspend Elevidys sales, calling it a “mugging” that could deter investment in new drugs. Another editorial referred to Prasad as “a one-man death panel.” RealClearHealth, a conservative media outlet, also called for his resignation.

FDA Reverses Decision, Prasad Departs

Just days after the initial decision, the FDA abruptly reversed course, allowing Elevidys back on the market for children with less advanced disease who had not lost their ability to walk. The next day, Prasad left the agency. Analysts suggested that political pressures likely played a role in his departure. Stifel analyst Paul Matteis noted that Prasad was “pushed out via higher political pressures.”

Duchenne patient advocates quickly responded to the FDA’s actions. Families affected by the disease wrote letters to Congress, created Change.org petitions, and traveled to Washington to meet with their representatives. Pat Furlong, founder of Parent Project Muscular Dystrophy, reported that some parents even reached out to contacts at the White House.

Reactions and Market Impact

Prasad did not comment on his departure, but a spokesperson for the Department of Health and Human Services stated that he wanted to avoid being a distraction and would return to California to spend more time with his family. When asked about Prasad’s replacement on CNBC, Makary mentioned having interest from “talented people” but did not provide further details. He praised Prasad as “a genius” and dismissed the criticism as “smear pieces.”

Prasad’s exit sent biotech stocks soaring. Sarepta’s stock jumped over 20%, while Replimune Group Inc. saw a 58% increase. Capricor Therapeutics Inc. also experienced a 22% rise. Analysts viewed the move as a positive for the sector, with BMO Capital Markets’ Evan Seigerman stating that Prasad’s departure may bring confidence and stability to the FDA.

Prasad’s Background and Controversies

Before joining the FDA, Prasad was an epidemiology professor at the University of California, San Francisco. He gained notoriety for criticizing the Covid vaccine for children. He was appointed director of the FDA’s Center for Biologics Evaluation and Research in May, replacing Peter Marks, who had been pushed out earlier due to differing views on vaccines from HHS Secretary Robert F. Kennedy Jr.

At the FDA, Prasad overruled reviewers in approving vaccines from Moderna and Novavax, arguing they should be limited to high-risk groups. This decision angered public health experts who believed the vaccines should be available to all. During his tenure, the FDA also rejected several rare disease drugs and imposed restrictions on Sarepta’s gene therapy, leading to perceptions of increased regulatory strictness.

Industry Outlook

Analysts believe Prasad’s departure may alleviate concerns among cell and gene therapy companies that have relied on expedited approval pathways. These pathways allow drugs to reach the market with less data, provided companies continue research to prove their efficacy. Sarepta used these pathways to get its Duchenne treatments approved.

William Blair analysts noted that a new FDA leader might be more open to innovation, potentially easing some of the current regulatory pressures. While the identity of Prasad’s successor remains unclear, the shift is seen as a potential turning point for the biotech industry.