What Caused Vinay Prasad's Quick Exit from Top FDA Role?

The leading vaccine representative from the U.S. Food and Drug Administration (FDA), Vinay Prasad, stepped down Within just three months of taking office, he faced significant criticism regarding his regulatory choices and endured harsh criticisms from conservative advocates. His strict monitoring of Sarepta Therapeutics’ gene treatment for Duchenne Muscular Dystrophy (DMD), a serious inherited condition, led to opposition from patient organizations and financial backers, while his methods also caused worries within the biotechnology sector concerning progress, conflicting with the FDA’s objectives, as noted by U.S.-based news sources.

Dr. Prasad, an oncologist known for strongly opposing U.S. policies on coronavirus vaccines and mask requirements, was named in May by FDA Chief Martin Makary. The two pledged to accelerate approval processes and introduce innovative evaluation methods, according to reports from Reuters.

Nevertheless, he encountered increasing attention regarding his choice to halt deliveries of Sarepta's Elevidys, a genetic treatment for DMD, following reports of three patient fatalities that triggered worries about safety, according to Reuters.

On July 18, the FDA instructed Sarepta to halt all deliveries of the authorized DMD treatment, based on safety issues.

The Food and Drug Administration's choice to stop deliveries caused anger among patient organizations and bio-tech investors, who claimed the treatment's advantages for a deadly illness were ignored.

On July 28, the FDA changed its decision, permitting deliveries to continue for outpatient individuals.

The way Prasad handled regulation, along with the lack of clear guidelines, caused worry among certain sectors of the biotechnology field, as some believed it might affect funding and creativity—leading to doubts about whether this aligns with Marty Makary’s goals, as mentioned in an opinion piece from the Wall Street Journal (WSJ).

The absence of well-defined, consistent guidelines during Prasad's tenure at the agency was causing significant confusion within the sector, particularly affecting smaller biotechnology firms, and risked discouraging funding, as stated in the opinion piece.

Prasad's strict stance regarding the structure of clinical trials also threatened to delay and increase expenses in developing medications. This contradicts what Marty Makary claims to aim for, as noted in the WSJ opinion piece.

A former Republican senator named Rick Santorum, linked to Sarepta Therapeutics, allegedly reached out to high-level White House officials to voice worries about Prasad's efforts to limit access to Elevidys, according to a report from the Daily Beast quoting The Times.

Sarepta has stated that its therapy did not contribute to the mentioned fatalities. Before becoming part of the FDA, Dr. Prasad had criticized the company, and after his appointment, Sarepta's stock fell by almost 25%, as reported by CNN.

Two individuals who are aware of the matter informed the Associated Press (AP) that Prasad was removed due to multiple recent issues.

Prasad began working for the FDA in May following several years spent as an academic scientist at the University of California, San Francisco, during which time he often expressed criticism toward the FDA's methods regarding medication approvals and COVID-19 vaccinations, according to AP.

VINAY PRASAD STEPS DOWN TO PREVENT DIVERSION VINAY PRASAD LEAVES POSITION TO AVOID INTERFERENCE VINAY PRASAD QUITs HIS ROLE TO MINIMIZE DISTRACTIO N VINAY PRASAD DEPARTS TO AVOID TROUBLE VINAY PRASAD RETIRES TO STAY FOCUSED

A representative from the U.S. Department of Health and Human Services informed CNN on July 29 that Vinay Prasad stepped down to prevent himself from becoming a "distracting factor" for the agency during the Trump administration, opting instead to go back to California to be with his family more often.

“Dr. Prasad didn’t wish to interfere with the significant efforts of the FDA during the Trump administration and has chosen to go back to California to dedicate more time to his family,” the representative said to the media outlet.

Later on, Prasad was also appointed as the FDA's Chief Medical and Scientific Officer.

Similar to many public health experts who were later hired during the Trump presidency, Prasad had earlier expressed strong opinions about the government's approach to managing the coronavirus outbreak and its vaccination plans.

The exit of Prasad occurred as new demands from the White House urged his resignation, according to an individual acquainted with the situation who remained anonymous when discussing internal developments, and this happened after several days of scrutiny from Laura Loomer, a conservative activist who has significant contact with former President Donald Trump, as noted by CNN.

On July 20, Loomer, who is closely aligned with Trump, wrote a blog entry alleging that Prasad was a "progressive left-wing troublemaker" and asserted that he was deliberately undermining the FDA's objectives.

Numerous ex-administration personnel and advisors, including campaign tacticians and public health experts, were publicly criticized by Loomer prior to being removed or let go by Trump.

Loomer, who identified as an investigative reporter, has established a reputation through bold speech, provocative methods, and an online platform fueled by controversy.

Although Loomer does not hold an official position within Donald Trump's campaign or political structure, her impact appears to align closely with the MAGA network. Multiple ex-administration personnel and advisors—spanning from campaign tacticians to public health experts—have been openly criticized by Loomer just prior to their removal or marginalization by Trump or his close associates.

Shortly before stepping down, the head of the FDA openly supported Prasad, stating to Politico that he is "a flawless scientist" and "among the top scientific thinkers of this era."

Prasad faced backlash from previous officials and vaccination specialists when internal documents from May showed that he disregarded FDA scientist suggestions regarding two updated coronavirus vaccines, according to CNN.