Are Pharma Lobbyists Behind Vinay Prasad’s Ouster from FDA?

U.S. | Science & Health | Rights & Freedoms

16 hours ago

Originally posted by: Children's Health Defense

The sudden ouster this week of Dr. Vinay Prasad from the top vaccine post at the U.S. Food and Drug Administration (FDA) followed directly on the heels of Prasad’s decision to pull a profitable gene therapy from the market

The decision provoked attacks from The Wall Street Journal’s Allysia Finley and Bob Goldberg at The Center for Medicine in the Public Interest. Both accused Prasad of serving as a “one-man death panel” for threatening to revoke access to medicine, investigative journalist Lee Fang reported.

In July, the FDA halted the clinical use of Sarepta Therapeutics’ drug Elevidys, used to treat Duchenne muscular dystrophy, following the deaths of three clinical trial participants.

FDA leadership met with Sarepta on July 18, instructed the company to halt all clinical trials and asked it to voluntarily stop all shipments of the drug. The company initially refused to halt shipments, according to the FDA, but eventually stopped shipping the drug on July 22.

The same day the FDA told Sarepta to end clinical trials for Elevidys, STAT News ran an op-ed attacking the FDA decision. It was authored by two mothers — Jennifer Handt, who founded Charlie’s Cure, and Kelly Maynard, who started the Little Hercules Foundation — investigative journalist Paul D. Thacker reported.

Sarepta funds Little Hercules and “Charlie’s Cure seems quite cozy with the company,” Thacker said.

Right-wing influencer Laura Loomer also attacked Prasad for his previous criticism of President Donald Trump and his support for Sen. Bernie Sanders (I-Vt.).

Several lawmakers also reached out to Trump directly, calling on him to remove Prasad. He reportedly did so over the objections of U.S. Health Secretary Robert. F. Kennedy Jr. and FDA Commissioner Marty Makary.

Prasad resigned from his position as FDA director of the Center for Biologic Evaluation and Research (CBER) on Tuesday. On Thursday, the FDA ended the temporary hold on Elevidys, allowing Sarepta to resume shipments for patients who can walk.

The reversal sent the company’s stock soaring. Nearly half of the company’s revenue comes from the drug.

Sarepta was ‘gearing up for a fight’

Evidence suggests that the attacks on Prasad are linked at least in part to lobbying by Sarepta, Fang reported.

“Behind the scenes, Sarepta Therapeutics was gearing up for a fight,” Fang wrote. “Following the death of two teenagers over side effects linked to Elevidys, the company began hiring lobbyists with close ties to the Trump administration.”

Fang found disclosures showing that on June 10, Sarepta hired lobbying firm Michael Best Strategies LLC, which employs prominent Republicans, including former Sen. Cory Gardner and former Republican National Committee Chair Reince Priebus.

“The most notable influence peddler at the firm is former Trump 2024 campaign co-director Chris LaCivita, who joined the company right after the inauguration,” Fang wrote.

Although Michael Best Strategies’ lobbying reports are vague, they state that the company worked on “Rare disease therapeutic development and access” with the Executive Office of the President, Congress and the U.S. Department of Health and Human Services (HHS).

Fang reported that the Center for Medicine in the Public Interest, whose reporter Bob Goldberg wrote one of the first attacks on Prasad, is also funded by Michael Best Strategies. And it receives funding from Pharma giants Pfizer, Novo Nordisk, Merck and Gilead Sciences.

“What else is going on behind closed doors remains unclear,” Fang wrote. “Rick Santorum also pressured the administration on Prasad’s removal. The New York Times noted this week that the former senator ‘has ties’ to Sarepta.”

Sen. Ron Johnson (R-Wis.) also reportedly raised concerns with the White House.

Loomer denied any connection to the drug industry. Fang said that many people “are concerned that drugmakers are figuring out ways to oust critics from senior roles.” Sen. Rand Paul (R-Ky.) told Politico he thought Big Pharma played a role in Prasad’s ouster.

According to a report released yesterday by OpenSecrets, pharmaceutical and health products companies spent $105.4 million during the second quarter of 2025 to influence public policy. Since 2010, the industry has spent more on lobbying than any other during every quarter but one, according to an OpenSecrets analysis of disclosure reports.

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Prasad’s temporary replacement also raised flags about Elevidys’ approval

George Tidmarsh, M.D., Ph.D., who earlier this month joined the FDA to direct its Center for Drug Evaluation and Research, will temporarily direct CBER until the HHS names a long-term replacement.

In April, shortly after a teenage boy died from Elevidys, Tidmarsh published a scathing critique of Dr. Peter Marks, who headed up CBER before Prasad under the Biden administration, and approved the drug over objections from his staff. Tidmarsh said Marks “disregarded the opinions and expert advice of long-time career scientists to advance his own dangerous agenda on at least 4 documented occasions.”

Two of those occasions included taking control of the COVID-19 vaccine decisions and fast-tracking the controversial Alzheimer’s drug Aduhelm or aducanumab, which was later pulled from the market after government investigators found the FDA didn’t follow protocol and lacked clinical trial data for the drug.

The other two instances were related to Elevidys. Tidmarsh reported that in June 2023, Marks overruled his staff scientists’ concerns when he approved the drug. In 2024, Marks expanded the drug’s approval, “despite FDA staff objections and without FDA Advisory Committee input.”

Timarsh wrote:

“Marks overruled his own career staff and experts in order to drive through a risky and unproven therapy. While advocates point to the need for new therapies in severe debilitating diseases such as DMD, giving patients and families hope with a toxic therapy that does not provide a clinical benefit rises beyond simple incompetence. A patient died needlessly and others have been harmed due to this incompetence.”

Now, three deaths may be linked to acute liver damage from Sarepta’s gene therapy products, but Elevidys is back on the market.

Politico reported the Trump administration is considering splitting CBER into two bodies — one focused on vaccine regulation and one on therapeutics.

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