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FDA Shake-Up: The Controversial Ouster Of The Top Vaccine Regulator

The Food and Drug Administration’s top vaccine and gene therapy regulator has reportedly been ousted from his position.

Dr. Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research, recently came under scrutiny for a request to pause shipments of a gene therapy for Duchenne muscular dystrophy (DMD), claiming the genetic treatment is linked to three potential deaths. Earlier this week, the FDA lifted the pause for DMD patients who are still able to walk.

Andrew Nixon, a spokesman for Health and Human Services, confirmed Prasad is no longer with the FDA but did not share details about his departure.

“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,” Nixon said in a statement. “We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”

In a statement issued on July 18, Prasad said the gene therapy — called Elevidys and made by Sarepta Therapeutics — needed to be paused for patient safety.

“Protecting patient safety is our highest priority, and the FDA will not allow products whose harms are greater than benefits,” he said. “The FDA will halt any clinical trial of an investigational product if clinical trial participants would be exposed to an unreasonable and significant risk of illness or injury,”

FDA Commissioner Marty Makary gave his support to Prasad, seeming to praise the “swift action.”

“Today, we’ve shown that this FDA takes swift action when patient safety is at risk,” Makary said. “We believe in access to drugs for unmet medical needs but are not afraid to take immediate action when a serious safety signal emerges.”

Some conservatives criticized Prasad for pausing the therapy. A piece published by RealClearHealth said Prasad was standing with “progressive health policies,” and not the president.

“Prasad’s hostility toward breakthrough therapies is not confined to policy memos. He has dismissed Elevidys as ‘disgusting’ because of its $3.2 million price tag, decried its ‘unclear benefit,’ and labeled it a ‘useless drug,’” the piece said. “He lumped it together with Sarepta’s earlier exon-skipping therapy Exondys 51, calling its approval the result of ‘shenanigans’ and ‘FDA politics’ overriding science.”

In the past, Prasad expressed publicly his skepticism of President Donald Trump’s “right to try” policy.

However, Emily Kopp, an investigative journalist from The Daily Caller, suggested Big Pharma was playing a role in the controversy. “Hit pieces on FDA’s Vinay Prasad are being fed to the right by pharma company Sarepta, the maker of an experimental drug that just killed an eight year old boy,” she wrote.

Though Prasad was a critic of COVID vaccine protocols and other pandemic-related approaches, his personal politics have also become a topic for some on the Right. Makary, however, recently defended Prasad from attacks. “There’s not a political bone to his body,” Makary said of Prasad last weekend. “He’s an impeccable scientist, I think one of the greatest scientific minds of our generation.”

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