Dr. Casey replaces Dr. Janette

Hours after news broke that President Trump was withdrawing the nomination of Janette Nesheiwat as surgeon general, he announced the new nominee, Casey Means.

Means is a health entrepreneur and Make America Healthy Again leader. Her brother, Calley Means, is an adviser to Health Secretary Robert F. Kennedy Jr. Isabella Cueto wrote the backstory about the Means siblings, how they became vocal critics of Big Food, Big Pharma, and what they see as a broken health care landscape that fails to prevent or reverse chronic disease.

Read more from Isa to find out why Nesheiwat’s nomination was pulled at the last minute and to read excerpts from a poem Means wrote, titled “The Devil’s Wellness Plan.”

fda

A Vinay Prasad threefer

The Trump administration has installed another contrarian who lacks civil service experience to an important government health care post.

Vinay Prasad will be the next director of the FDA’s biologics center, which oversees vaccines, gene therapies, and the blood supply.

As an epidemiology professor at the University of California, San Francisco, Prasad has taken the agency to task, including the biologics center, for being too cozy with the pharmaceutical industry and falling short on safety and efficacy standards, according to Lizzy Lawrence, Jason Mast and Matthew Herper. He’s been especially critical of expensive new cancer medicines targeted to particular tumor mutations that he said sucked up resources and didn’t work well. He also didn’t like the Biden administration’s response to Covid-19. Read more on Prasad’s background.

Unlike most civil servants, Prasad has written a lot, in blogs, on websites like STAT, and in peer reviewed journals. He's no shrinking violet. He’s very online, often sparring on social media and speaking his mind on his Substack.

And yet, in his first speech to FDA staff, he struck a milder and more humble tone, praising their work and emphasizing the importance of medical evidence.

A team of STAT reporters combed through his past writings to present Prasad’s views in his own words and explain how those views may shape his approach.

After reports of his appointment, the S&P Biotech ETF tumbled more than 6%.

But should industry panic? Biotech columnist Adam Feuerstein doesn’t think so.

Adam predicts that Prasad will be less flexible than his predecessor Peter Marks when it comes to therapies for rare disease. But that’s not necessarily always a bad thing, and it doesn’t mean companies and investors must abandon the field. FDA Commissioner Marty Makary is still in charge of the agency, and Makary said he wants to streamline FDA functions and speed reviews of rare-disease treatments.

“Makary and Prasad are friends,” Adam writes. “Makary picked Prasad to run CBER.” Read more of Adam’s thoughtful analysis.

food safety

FDA rehires food safety scientists

The FDA has officially rehired food safety scientists in Chicago, two scientists confirmed to Lizzy.

The Chicago lab, part of the FDA's Human Foods Program, conducts research to prevent foodborne outbreaks. The scientists worked on projects related to bird flu testing in milk, contaminants in food packaging, and risks in powdered infant formula manufacturing.

FDA Commissioner Marty Makary told CNN last month that the April layoffs across FDA did not impact scientists or inspectors, which was not true. In addition to laying off scientists in Chicago, the agency cut all 23 employees at a drug safety lab in Puerto Rico. Those scientists have not been rehired as of now, one of them confirmed to STAT.

An HHS spokesperson blamed siloed HR divisions for the mistaken layoffs.

nih

NCI feeling the pain of budget cuts

Angus Chen and Jason Mast provide an update on the National Cancer Institute, the largest of NIH’s institutes.

The NCI has not been immune to the budget cuts and terminations at HHS, and more cuts are on the way to its contracts budget. It’s not all doom and gloom. Interim NCI Director Doug Lowy has managed to keep some basic functions running. New notices of grant awards are still coming in, Angus and Jason report. Patients continue to be treated at the NIH hospital as well and move forward with trials, albeit with delays in some cases.

But the cuts are affecting a hotline for patients, cancer.gov, and scientific advisory panels. Read more.

drug industry

Pharma’s place in MAGA

Drugmakers need to figure out where they fit in Trump’s vision for a new American Golden Age, according to Joe Grogan, who served as assistant to President Trump and director of the Domestic Policy Council during Trump’s first administration.

The energy sector promises to provide cheap, abundant energy. Elon Musk says space exploration could make humans an interplanetary species and enhance commercial activity in the heavens. The tech sector touts artificial intelligence as a way to free us from mundane tasks and enhance productivity.

“What is the biotech promise?” Grogan asks. It’s an especially important question as Trump reportedly continues to pursue the idea of lowering U.S. drug prices to be more in line with the cheaper prices that European nations pay.

Read Grogan’s First Opinion here.

congress

Confusion reigns on the Hill

House Speaker Mike Johnson (R-La.) said Tuesday that House Republicans would probably not cut the federal Medicaid funding match rate to states or cap federal funding for the expansion population to help pay for Trump’s tax cuts.

That position is meant to placate moderate Republicans, but it immediately drew the ire of conservatives such as Rep. Chip Roy of Texas, and Johnson needs nearly every member of his party to vote for the budget reconciliation bill.

To complicate matters, Senate Majority Leader John Thune (R-S.D.), who previously had been expected to go easier on Medicaid cuts than the House, reportedly said the House wasn’t being aggressive enough.

Read more from Daniel Payne and me about the obstacles Republicans are encountering in their quest to cut Medicaid funding without angering voters.

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