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Sources also say that the administration plans to split CBER in two, with one of the section focused entirely on vaccines.
President Trump reportedly pushed for the removal of Vinay Prasad from his position at CBER.
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Drama at FDA continues to unfold, with a new report suggesting that President Trump was directly involved in the departure of Vinay Prasad, former head of CBER.
Prasad resigned from his position in late July, stating that he did not want to be a distraction and planned to spend more time with his family. The announcement came in the middle of drama involving multiple FDA decisions, primarily the ongoing drama with Sarepta Therapeutics and its Duchenne muscular dystrophy drug Elevidy. The agency also sparked controversy when it issued a CRL to Replimune in a move that analysts called unexpected and was criticized for citing issues that had not been raised with the company during its mid- and late-cycle reviews.
At the time, Pharmaceutical Executive reported that FDA issued a statement confirming that Prasad had stepped down. That statement concluded with “We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”
According to a report from Politico,1 however, it appears that President Donald Trump may have been directly involved in a push to remove Prasad. The report cites four anonymous insiders who state that Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary opposed these efforts.
The report states that Prasad came under fire for multiple reasons, but the main reason appears to be him having become the target of political commentator and Trump ally Laura Loomer. The controversial right-wing voice had criticized Prasad for previously publicly supporting prominent Democrats, such as Senators Bernie Sanders and Elizabeth Warren. Prasad also supported former President Joe Biden’s campaign in 2020.
Loomer also criticized Prasad for his handling of the ongoing Sarepta situation, which saw FDA briefly call for all shipments of the drug Elevidys to be halted in the United States due to safety concerns. After a brief pause, however, Sarepta resumed shipments with support from FDA.
Politico’s report also states that President Trump is considering further action with CBER. The sources state that the administration is considering splitting the organization into two bodies. One would be focused on overall therapeutics, while the other would focus solely on vaccines. This would potentially allow for Secretary Kennedy to appease groups like Children’s Health Defense, a group criticized for being considered anti-vaccine with whom he has a relationship with.
The anonymous sources told Politico that they were worried that the splitting of CBER would provide Kennedy the opportunity to fill the organization with “hardcore anti-vaxxers.”
Kennedy has long come under fire from a variety of groups who have described him as “anti-vax.” The Secretary, however, denies that he is anti-vax, although he has been publicly critical of vaccines and has been aligned with groups that many consider to be anti-vaccine.
Under Kennedy’s leadership, and during the Prasad’s time at the agency, FDA has made several key decisions regarding vaccines. Prasad oversaw the approval of Moderna’s COVID-19 vaccine for children between the ages of 6 and 11 who have an increased risk of COVID. However, 17 experts who were part of a government panel on vaccines were all ousted. CBS News reports that these experts say that they were replaced with an inexperienced and biased panel.2 They also said that “the rigor and discipline of these vaccine recommendation processes are rapidly eroding” at the industry. Kennedy defended his decision, however, saying that he believed a clean sweep was necessary to restore public confidence.
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