Top FDA Official Resigns Under Pressure (Jul 2025) After turning down several new drugs and restricting use of another, Dr. Vinay Prasad drew the ire of the right-wing influencer Laura Loomer and others Article

[Michael Harrop]

https://www.nytimes.com/2025/07/29/health/vinay-prasad-fda-resigns-loomer.html
https://archive.ph/JEveK

This is big, but I'm not sure if it's good or bad for FMT. Based on the article, he seems like the kind of person who would work to make FMT available, but then again, maybe not, and he didn't seem to do anything about it during his time in office.

I wonder what Laura Loomer thinks about FMT.

The Food and Drug Administration’s top vaccine and gene therapy official resigned on Tuesday after a public campaign against him led by the right-wing influencer Laura Loomer, according to people familiar with the matter.

Over the past week, Ms. Loomer had taken to social media to attack the official, Dr. Vinay Prasad, for a series of decisions denying approval of new drugs for rare diseases. She highlighted past statements of support he had made for prominent figures on the political left, including Senator Bernie Sanders, independent of Vermont.

As Ms. Loomer’s campaign escalated, the federal health secretary, Robert F. Kennedy Jr., who oversees the F.D.A., had privately defended Dr. Prasad, according to people familiar with the matter. Mr. Kennedy’s support, they said, stemmed in part from his role overseeing vaccines. During his brief tenure at the F.D.A. Dr. Prasad had already limited the use of Covid shots and had amped up warnings about a rare cardiac side effect of the inoculations.

Dr. Marty Makary, the F.D.A. commissioner, also defended Dr. Prasad in an interview on Saturday with Politico, calling him an “impeccable scientist.”

Yet it wasn’t enough in the face of criticism from Ms. Loomer and lobbying of White House officials by former Senator Rick Santorum, which reached President Trump this week.

Ms. Loomer also surfaced old social media posts in which Dr. Prasad declared that he was a “political liberal” and another where he said he had a Trump “voodoo doll.”

Dr. Prasad also faced heat for cracking down on the company Sarepta Therapeutics, which came under heightened scrutiny after two teenagers and a 51-year-old man died of liver complications after using the company’s gene therapy drugs.

Mr. Santorum, who has ties to Sarepta, also reposted an editorial lambasting Dr. Prasad on social media and called top officials at the White House to relay his concerns

Dr. Prasad was also the centerpiece of a Wall Street Journal opinion article whose headline called him “a Bernie Sanders Acolyte in MAHA Drag.”

Dr. Prasad made inroads with the political right during the pandemic, slamming public health efforts such as social distancing and putting masks on toddlers. He had also expressed openness to supporting placebo-controlled trials of vaccines in the past, a top priority of Mr. Kennedy.

He became well-known in medical circles for arguing that the F.D.A. was greenlighting too many medicines based on weak standards of evidence.

Click to shrink...

Today, Senator Chuck Grassley spoke on the Senate floor, approving of Dr. Prasad's firing. Senator Grassley is a proud advocate of the right-to-try law.

He criticized the use of "quality-adjusted life years" for prescription drug programs, which he said Dr. Prasad supported.

He said:

If there's a cure or a treatment, we should be able to access it regardless of what government bureaucrats think.

The government should use every opportunity to promote a potential miracle cure or breakthrough treatment.

He says Prasad was not in favor of the right to try law.

He said Prasad has long criticized the FDA for approving too many treatments, which in his view, only provide marginal benefits.

Click to shrink...

It sounds like he's using the word "treatments" interchangeably with "drugs".

 

[Michael Harrop]

Here's a related article by Laura Loomer:

Meet Vinay Prasad: The Progressive Leftist Saboteur Undermining President Trump’s FDA https://loomered.com/2025/07/20/meet-vinay-prasad-the-progressive-leftist-saboteur-undermining-president-trumps-fda/

In a stunning betrayal of President Donald Trump’s “Make America Healthy Again” vision, [...]. Far from being the reformist ally the Trump administration expected he may be, [...] deliberate actions to obstruct the President’s deregulatory agenda [...]. His continued presence at the FDA threatens to derail the Trump administration’s mission to streamline regulations and prioritize American health.

Click to shrink...

Most of it goes on to cover his political leanings.

Stalling Deregulatory Reforms

Makary’s “plausible mechanism” pathway for rare diseases, a flagship initiative to accelerate drug approvals, has stalled under Prasad’s leadership. Analysts question whether his progressive views can align with Makary’s deregulatory approach, casting doubt on his commitment to Trump’s goals.

Click to shrink...

Missed Deadlines and Regulatory Gridlock Under Prasad

The FDA has missed multiple Prescription Drug User Fee Act (PDUFA) deadlines under Prasad. Examples of these missed deadlines are GSK’s Nucala for COPD (May 7) and Stealth BioTherapeutics’ Barth syndrome treatment (April 29). More recently, Prasad has led arbitrary delays of gene and cell therapies from Ultragenyx and Capricor not based on science, but on his own left-wing agenda. These delays contradict Trump’s push for faster drug approvals, frustrating patients and industry alike.

Click to shrink...

Hard to say whether this is pro-pharmaceutical company, or if she's willing to apply it to FMT as well.

Prasad’s regulatory philosophy is fundamentally anti-Trump. While the President has criticized the FDA’s “slow and burdensome” approval process, he has argued for tougher reviews. Also, Prasad dismissed Republican pressure to streamline approvals as misguided. He criticized Trump’s Right-To-Try policies, calling the President “incorrect” and blaming pharmaceutical companies, not the FDA, for delays in drug access. By publishing major policy changes in academic journals rather than through transparent public comment portals, Prasad has reduced opportunities for input from patients, providers, and industry, further eroding trust in the FDA.

Click to shrink...