Vinay Prasad Exits FDA: Abrupt Resignation of CBER Director & Chief Medical Officer After 3 Months | Sarepta Gene Therapy Controversy, Political Pressure & Regulatory Impact

Key Takeaways

• Abrupt Exit: Vinay Prasad resigned as FDA’s biologics chief after less than three months amid political pressure and drug approval controversies .
• Sarepta Controversy: His scrutiny of Elevidys, a Duchenne muscular dystrophy therapy, led to shipment halts after a patient death, reversed days before his departure .
• Political Targeting: Right-wing activist Laura Loomer spearheaded a smear campaign, branding Prasad a “progressive saboteur” for past critiques of Trump and COVID policies .
• Scientific Clash: Prasad overruled FDA scientists on COVID vaccines, limiting boosters to high-risk groups, drawing ire from public health experts .

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The Resignation Heard ‘Round the Beltway

Vinay Prasad quit on a Tuesday. The FDA’s biologics chief walked out after 89 days, a blip in bureaucratic time. The press release claimed “family reasons.” Those words taste like cardboard. Thin as hospital soup. Health and Human Services spat out the line: “He did not want to be a distraction” . Translation: the walls closed in. White House pressure. Loud voices. A resignation letter signed with a shiv.

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The Sarepta Storm

Prasad inherited Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy. He’d long called it “bad policy.” Weak evidence. Fatal risks. In July, a boy died in Brazil. Prasad halted shipments . Then, the reversal. One day before his exit, FDA greenlit shipments for “certain patients.” Science bent to politics, again.

Table: Elevidys Timeline Under Prasad

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Laura Loomer’s War Drum

Laura Loomer smells blood like a terrier. Right-wing agitator. Trump whisperer. She tore into Prasad for weeks. “Progressive leftist saboteur,” she barked . Dug up old podcasts. Social media jabs at Trump. Called him a “Bernie Sanders acolyte” . Rick Santorum piled on. Wall Street Journal ran the hit. The White House listened.

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The Vaccine Muzzle

Prasad hated COVID dogma. Masks. Kid shots. Boosters for all. As CBER chief, he overruled FDA scientists in May. Scrapped broad recommendations for new COVID vaccines. Approved only for the old. The weak. Not the young . Public health experts howled. “Anti-science,” they cried. He called it evidence.

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Makary’s Brief Shield

FDA Commissioner Marty Makary stood by him, once. “Impeccable scientist,” he told Politico days before the fall. “Greatest mind of our generation” . Then silence. When Prasad left, Makary offered no words. Just a HHS spokesperson tossing thanks like a bone to a dog .

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The Rare Disease Dilemma

Rare diseases break hearts. Duchenne kills boys. Parents beg for hope. Pharma sells it. Prasad demanded proof. “Symptoms must stall. Reverse. Show data,” he insisted . Families called him cruel. Investors called him a roadblock. The FDA blinked. Let the therapy flow. Death or hope, who decides?

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Ghost in the Bureaucracy

“Style is the answer to everything. A fresh way to approach a dull or dangerous thing.”

Prasad had style. Not the kind you see. The kind that grinds. Question everything. Drug approvals. Vaccine mandates. He walked into FDA, a critic turned boss, and tried to burn the place clean. Lasted 89 days. Hemingway had style with a shotgun. Prasad had a resignation letter. Same result.

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The Aftermath: Vacuum and Vultures

Biotech stocks jumped at his exit. Sarepta up 11%. Replimune up 58% . Investors cheered. Scientists whispered. Who next? A “seasoned official,” analysts hoped . Someone predictable. Someone who won’t rock the boat. The FDA’s credibility? Cracked like an egg.

Table: Market Reaction to Prasad’s Exit

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Legacy: The Critic Who Tried

Prasad wrote books. Malignant. Ending Medical Reversal. Five hundred academic papers . He knew the game. Knew drug approvals were greased with money and tears. Took the job anyway. Lasted 89 days. Now he’s back in California. Watching the ocean. The FDA rolls on. Same as ever.

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Frequently Asked Questions

Why did Vinay Prasad leave the FDA?

He resigned amid pressure from the White House and a right-wing smear campaign led by Laura Loomer, who targeted his past criticism of Trump and COVID policies .

What was Prasad’s role in the Elevidys controversy?

As biologics chief, he halted shipments of Sarepta’s Duchenne therapy after a patient death, then reversed the decision days before quitting, allowing limited use .

How did Prasad change COVID vaccine policy?

He restricted boosters to older/high-risk groups, rejecting broad use for young people, a move that overruled FDA scientists .

Did political views drive Prasad out?

Loomer’s attacks framed him as a “progressive saboteur,” citing past support for Bernie Sanders. The White House pressured him to resign .

What’s next for the FDA’s biologics division?

Analysts expect a “seasoned” replacement to stabilize approvals, especially for gene therapies like Elevidys .