Agency official re-joins FDA following dismissal led by Loomer
Dr. Vinay Prasad has returned to his role at the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) less than two weeks after resigning, following pressure from the White House and senior health officials who opposed his dismissal and encouraged his reinstatement.
The reinstatement of Dr. Prasad has sparked renewed controversy, with some observers viewing it as a test of political resilience by the FDA leadership. The decision was supported by HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, demonstrating high-level backing within the administration despite ongoing controversy.
Laura Loomer, a right-wing activist, had been criticizing Dr. Prasad publicly for days, accusing him of aligning with liberal politicians and expressing "disdain" for former President Trump. Loomer has continued her attacks, promising further "exposes" of officials, and the situation has reportedly contributed to low morale within the FDA staff.
Dr. Prasad's resignation came amid escalating tensions from social media attacks by Loomer and others, who criticized his past political remarks and his regulatory decisions, especially concerning Sarepta Therapeutics’ gene therapy for Duchenne Muscular Dystrophy (DMD), Elevidys.
Internal memos from May revealed that Dr. Prasad overrode FDA scientists on recommendations for two new versions of Covid-19 vaccines. The then-CBER director rebuked recommendations for broad use of the shots; the FDA eventually approved the vaccines for use in older and immunocompromised people but did not advise them for younger Americans who don't have underlying conditions.
It is unclear if Dr. Prasad will also return to his role as FDA chief medical and scientific officer. Dr. Prasad's resignation was due to not wanting to be a distraction and returning to California to spend more time with his family. However, pressure from the White House for him to resign may have also played a role.
The return of Dr. Prasad to the FDA has reignited debates around regulatory policies in gene and cell therapies. Some view it as a challenge to the FDA's independence, while others see it as a necessary step to ensure that innovative treatments are not unduly delayed.
Andrew Nixon, Health and Human Services spokesperson, made a statement about Dr. Prasad's return to the FDA. CNN's Meg Tirrell, Sarah Owermohle, and Adam Cancryn contributed to this report. Figures including former US Sen. Rick Santorum and others have criticized Dr. Prasad, labeling him as "the man destroying @POTUS legacy for helping patients." Loomer attacked Dr. Prasad as a "progressive leftist saboteur" undermining President Trump's FDA.
References:
- FDA's Prasad returns to role after pressure from White House, senior health officials
- FDA's Prasad resigns amid pressure from White House and social media attacks
- FDA's Prasad reinstatement sparks debate over regulatory policies in gene and cell therapies
- The reinstatement of Dr. Prasad at the FDA, following pressure from the White House and senior health officials, has ignited discussions about politics and policy-and-legislation within the administration.
- The controversy surrounding Dr. Prasad's return to the FDA extends to war-and-conflicts in the realm of politics, with political figures like former US Senator Rick Santorum criticizing him and accusing him of undermining the former President's legacy.
- The general-news landscape is also influenced by the return of Dr. Prasad to the FDA, as reactions to his reinstatement reveal ongoing debates around crime-and-justice, particularly accusations of him being a progressive leftist saboteur.
