What forced Vinay Prasad to exit top job at US FDA in just 3 months

The US Food and Drug Administration's (FDA) top vaccine official, Vinay Prasad, stepped down in less than three months after his appointment, following intense scrutiny over his regulatory decisions and political attacks from conservative activists. His stringent oversight of biopharmaceutical company Sarepta Therapeutics' gene therapy for Duchenne Muscular Dystrophy (DMD), a severe genetic disorder, sparked backlash from patient groups and investors, while his approach also raised concerns among biotech firms about innovation, clashing with FDA priorities, according to reports in US-based media outlets.

Prasad, an oncologist who was a fierce critic of the US COVID-19 vaccine and mask mandates, was appointed in May by FDA Commissioner Marty Makary. Together, they promised to speed regulatory action and pilot new review pathways, news agency Reuters reported.

However, he faced mounting scrutiny over his decision to pause shipments of Sarepta's Elevidys, a gene therapy for DMD, after three patient deaths raised safety concerns, Reuters reported.

The FDA, on July 18, asked Sarepta to stop all shipments of the approved DMD therapy, citing safety concerns.

The FDA's decision to halt shipments sparked outrage from patient groups and biotech investors, who argued the therapy's benefits for a fatal disease were overlooked.

On July 28, the FDA reversed course, allowing shipments to resume for ambulatory patients.

Prasad's regulatory approach and the absence of clearly defined standards prompted concern within parts of the biotech industry, with some suggesting it could impact investment and innovation – raising questions about alignment with Marty Makary's priorities, according to an op-ed in the Wall Street Journal (WSJ).

The agency's lack of clear, predictable standards under Prasad was creating enormous uncertainty for the industry, especially small biotech companies, and threatened to chill investment, according to the op-ed.

Prasad's inflexible position on the design of clinical trials also risked slowing and raising costs for drug development. This is the opposite of what Marty Makary says he wants to do, the WSJ op-ed added.

Former Republican Senator Rick Santorum, who has connections to Sarepta Therapeutics, reportedly contacted senior White House officials to express concerns over Prasad’s attempts to restrict the use of Elevidys, Daily Beast reported, citing The Times.

Sarepta has maintained that its treatment was not responsible for the reported deaths. Prior to joining the FDA, Dr Prasad had voiced criticism of the company, and following his appointment, Sarepta's stock dropped by nearly 25%, according to CNN.

Two people familiar with the situation told the Associated Press (AP) that Prasad was ousted following several recent controversies.

Prasad joined the FDA in May after years as an academic researcher at the University of California, San Francisco, where he frequently criticised the FDA's approach to drug approvals and Covid-19 vaccines, AP reported.

VINAY PRASAD RESIGNS TO AVOID DISTRACTION

A Department of Health and Human Services spokesperson told CNN on July 29 that Vinay Prasad resigned to avoid being a "distraction" to the agency's work under the Trump administration, choosing to return to California to spend more time with his family.

"Dr Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family," the spokesperson told the broadcaster.

Subsequently, Prasad was also given the role of FDA chief medical and scientific officer.

Like several health officials later appointed under the Trump administration, Prasad had previously been outspoken in his criticism of the government’s handling of the Covid-19 pandemic and its vaccine strategies.

Prasad's departure came amid fresh pressure from the White House for him to resign, according to a person familiar with the matter who was granted anonymity to describe the internal dynamics, and followed days of criticism from Laura Loomer, a right-wing activist with extraordinary access to President Donald Trump, CNN reported.

On July 20, Loomer, a close Trump supporter, published a blog post accusing Prasad of being a "progressive leftist saboteur" and claiming he was actively working against the mission of the FDA.

Several former administration officials and advisers, from campaign strategists to public health voices, faced public targeting by Loomer before being sidelined or dismissed by Trump.

Loomer, who called herself an investigative journalist, has built a reputation for aggressive rhetoric, confrontational tactics, and a social media presence that thrives on outrage.

While Loomer has no formal role in Donald Trump's campaign or political machinery, her influence seems to travel in parallel with the MAGA ecosystem. Several former administration officials and advisers – ranging from campaign strategists to public health voices – have found themselves publicly targeted by Loomer shortly before being sidelined or dismissed by Trump or his inner circle.

Just days before his resignation, the FDA Commissioner publicly defended Prasad, telling Politico that he is "an impeccable scientist" and "one of the greatest scientific minds of our generation."

Prasad also drew criticism from former officials and vaccine experts after internal memos from May revealed that he overrode FDA scientists on recommendations for two new versions of COVID-19 vaccines, CNN reported.

- Ends