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FDA Official Vinay Prasad Resigns Amid Controversy Over Rare Disease Drug

FDA Official Vinay Prasad Resigns Amid Controversy Over Rare Disease Drug

Dr. Vinay Prasad, the controversial critic of the US Food and Drug Administration who took a top role at the regulatory agency in May, has resigned less than three months into the job.

Prasad, a hematologist oncologist, was named head of the FDA’s Center for Biologics Evaluation and Research in early May, giving him purview over vaccines and biologic medicines. He was subsequently also given the role of FDA chief medical and scientific officer. Like a number of Trump administration health appointees, Prasad had been a harsh critic of the government’s response and vaccine policies during the Covid-19 pandemic.

Vinay 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.

Loomer had taken shots at him on her website and on social media, attacking him publicly for days as a “progressive leftist saboteur” who was “undermining President Trump’s FDA.”

Loomer focused on Vinay Prasad’s previous social media posts and podcast episodes, where she said Vinay Prasad aligned himself politically with liberal politicians and expressed “disdain” for Trump. Her posts were followed by others from figures including former US Sen. Rick Santorum, who called Prasad “the man destroying @POTUS legacy for helping patients,” and a Wall Street Journal opinion piece headlined, “Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag.”

Prasad didn’t respond to requests for comment. A White House spokesperson referred a request for comment to HHS.

FDA Official Vinay Prasad Resigns Amid Controversy Over Rare Disease Drug

Who is Vinay Prasad?

In May, Prasad, a hematologist and oncologist was appointed head of the FDA’s Centre for Biologics Evaluation and Research, granting him authority over vaccines and biological medicines. Subsequently, he was also appointed the FDA’s chief medical and scientific officer. Similar to several Trump administration health appointees, Prasad had been a vocal critic of the government’s response and vaccine policies during the COVID-19 pandemic.

Vinay Prasad’s decision to leave the FDA

The report, citing people aware of the development, said Prasad resigned amid pressure from the White House. Additionally, Laura Loomer, a right-wing activist known to have close ties with Donald Trump, consistently criticised Prasad. She publicly criticised him for days on her website and social media, calling him a “progressive leftist saboteur” who was “undermining President Trump’s FDA.”

Loomer called out Prasad’s previous social media posts and podcast episodes, where she claimed that he supported liberal politicians and expressed “disdain” for Trump.

However, FDA Commissioner Dr. Marty Makary defended Prasad just days ago. In an interview with Politico, Makary said Prasad is an “impeccable scientist … one of the greatest scientific minds of our generation.”

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

Dispute over Sarepta’s gene therapy

Prasad took on his role at the FDA following years of outspoken criticism of certain drug approvals by the agency. Notably, he condemned the approval of Sarepta’s Duchenne muscular dystrophy drug, Elevidys, asserting that there was insufficient evidence to demonstrate it effectively slowed or reversed symptoms of this rare and deadly genetic condition.

This month, the FDA asked Sarepta to stop shipments of the drug after a reported death of a young patient in Brazil. Just one day before Prasad’s departure, the agency unexpectedly reversed its decision and allowed Sarepta to continue shipments for certain patients.

Prasad faced criticism from former officials and vaccine experts after May’s internal memos showed he overruled FDA scientists on two new Covid-19 vaccine versions. The then-CDER director criticised the broad use of these vaccines; ultimately, the FDA approved them for older and immunocompromised individuals but did not recommend them for younger Americans without underlying health conditions.

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