What’s behind the abrupt exit of FDA’s Prasad?

The exit of the FDA’s Vinay Prasad is being chalked up to a series of controversial decisions on rare disease drugs by the biologics center he directed. Read Lizzy Lawrence’s article on his upcoming departure, and check out Matthew Herper’s take on how Prasad flew too close to the sun and the lessons from his sudden, second fall.

What’s less clear is whether Prasad is being forced out, and if so, by whom. (FDA Commissioner Marty Makary said Prasad’s sabbatical was coming to an end and he was returning to UCSF.) CNN reported last summer that White House chief of staff Susie Wiles was behind Prasad’s first, brief departure.

Congressional Republicans also seem to have lost patience with Prasad. The Senate Committee on Aging on Feb. 26 held a hearing to let rare disease patient advocates testify about their frustrations with how the FDA is handling rare disease drugs.

Prasad’s name did not come up, but Chair Rick Scott (R-Fla.) complained about inconsistent review practices for rare disease drugs, and the practices he listed — “shifting standards and redundant, often late, data requests” — align with complaints about Prasad.

Scott said he’s spoken to Makary about those problems, and he emphasized that the commissioner inherited them. However, Annie Kennedy, the chief mission officer of the Everylife Foundation for Rare Diseases, who testified before Scott’s committee, said the issues started last year.

Scott’s office did not respond when asked whether he thinks that Prasad's exit will help the FDA reset its approach to rare disease treatments.

Sen. Ron Johnson (R-Wis.), one of the earliest and most supportive lawmakers of the MAHA movement, said he was “enraged” by the agency’s dismissive attitude toward rare disease patients. Johnson attributed the problem to career FDA employees, not recent political appointees.

“You have my commitment,” Johnson said during the hearing. “I’m going to delve into this. We’re going to right this wrong.”

Asked about those comments a day before Prasad’s exit was announced, Johnson said he plans to use public pressure to get changes at FDA. He also said he’d spoken to Makary since the hearing, but he declined to give details about that conversation.

“You heard director Makary say all the right things, but the agency is just doing all the wrong things,” Johnson said. “It’s puzzling to me.”

fda

FDA shies away from adcomms

One of the complaints during the Aging hearing was that the FDA has drastically cut the number of advisory committee meetings it holds. Lizzy has more on that front.

The FDA convenes meetings of independent advisers when faced with difficult or controversial regulatory decisions. The advisory panels give doctors, patients, and others a chance to provide input to the agency, and the meetings offer a window into the scientific debate over FDA product reviews.

But the number of advisory committee meetings related to drugs decreased by 72% last year, according to an analysis by Genevieve Kanter, a public policy professor at the University of Southern California.

Can MAHA still change vaccine policy?

A coalition of health secretary Robert F. Kennedy Jr.’s allies held an event on Monday focusing on anti-vaccine messages as the Trump administration tries to shift attention away from vaccine policy.

Chelsea Cirruzzo attended the event, which was hosted by the MAHA Institute and included speakers from Children’s Health Defense, the McCollough Foundation, and the Brownstone Institute. The groups complained that the FDA and other agencies were too afraid, even now, to take action on vaccine injuries.

The roundtable on vaccine injuries was long on griping and short on policy. But there were a few policy suggestions smattered about. MAHA Institute President Mark Gorton called for eliminating the childhood vaccine schedule. Political polling has shown that most people support the childhood vaccine schedule.

Other speakers claimed a debunked link between vaccines and autism, eczema, and other chronic diseases. But it was unclear whether they thought HHS had their back on those claims.

Kennedy was rarely mentioned, except when speakers reassured the audience he was working hard for them.

Mary Holland, CEO of Children’s Health Defense, told attendees she was encouraged by state medical freedom laws and federal legislation to end vaccine liability protections. “I think there's a discussion about these issues in the administration in HHS and the Department of Justice,” she added. Later she told attendees: “We are winning.”

weight loss drugs

Novo, Hims strike deal

Novo Nordisk and Hims & Hers have reached an agreement. The Danish drugmaker will drop its patent-infringement lawsuit against Hims, and Hims will stop selling compounded versions of Novo’s branded weight loss drug, Elaine Chen reports.

Novo hopes the deal will boost sales from Hims’ large customer base. Hims agreed to offer Wegovy injections and pills on its website at cash prices, as do Novo’s other telehealth partners.

Novo said it reserves the right to refile its lawsuit, but for now the deal appears to end the bitter dispute. Read more.

hospitals

Is AI upcoding or accurately coding?

Brittany Trang wrote about a new insurer-affiliated report that offers possible evidence that AI coding might be driving up the cost of health care.

The new report focuses on a single code that describes a loss of blood after childbirth big enough to drop hemoglobin levels. Some hospitals started billing more often for that code, even though they didn’t provide more blood transfusions, which is how the condition is often treated. However, some in the hospital industry say post-hemorrhagic anemia after childbirth doesn’t always require a blood transfusion, the code for that condition is often overlooked, and suggest AI is merely catching that oversight.

What we’re reading

Health tech company says it will dive into Medicare’s new chronic care experiment, STAT
Newsom picks a dogfight with Trump and RFK Jr. on public health, KFF Health News
Federal autism advisory board cancels first public meeting since overhaul,