That was fast: Vinay Prasad is back at CBER

Vinay Prasad is returning to lead the biologics division of the FDA just two weeks after his ouster, which followed a right-wing campaign criticizing his past liberal-leaning posts as well as reported White House intervention. His reinstatement, confirmed by HHS, comes after FDA Commissioner Marty Makary urged him to consider returning, STAT's Lizzy Lawrence writes.

During his three-month tenure, Prasad tightened Covid-19 vaccine eligibility, increased scrutiny of gene therapies, and halted shipments of Sarepta Therapeutics' Elevidys treatment for Duchenne muscular dystrophy after patient deaths.

"The widespread instability in public health leadership and advisory committee membership that this is part of is confusing and may heighten concerns about FDA's decisions," said Jesse Goodman, previously the director of CBER at FDA.

Meanwhile, the day before Prasad's return was announced, employees at at FDA town hall raised concerns about staffing and impromptu expert meetings.

RESEARCH

Trump order shifts grant power to political appointees

The Trump administration has issued an executive order granting presidential appointees sweeping authority over federal research grants, sidelining peer review and career civil servants in favor of advancing White House priorities. The directive allows politically appointed officials to approve funding announcements, terminate existing grants "for convenience," and favor institutions with lower overhead rates. Experts expressed concern that the moves inject partisan politics into science.

"The overwhelming evidence is that when we politicize previously apolitical processes, the performance goes down and the quality of the work decreases," said David Lewis, a professor of political science at Vanderbilt University who has studied how federal agencies operate under presidential appointees. "What I worry about, when I think about how much support for federal science has led to dramatic breakthroughs, are the opportunities that will be missed by bad decisions."

POLICY

HHS cites studies it says justify canceling mRNA contracts

When he canceled $500 million worth of federal grants to support mRNA vaccine development, health secretary Robert F. Kennedy Jr. offered little specific scientific justification. On Friday, when asked where it could provide any, the Department of Health and Human Services pointed to a 181-page list of studies on mRNA research compiled by vaccine critics.

The announcement has alarmed many public health experts, who say mRNA vaccine technology saved countless lives during the Covid-19 pandemic. The studies cited by HHS, however, reference a number of studies that purportedly show that the spike protein produced by an mRNA vaccine is "harmful by itself, independent of the rest of the virus."

cystic fibrosis

Advocates push South Africa to reopen Vertex probe

Patient advocacy groups in South Africa are urging the government to revive an antitrust investigation into Vertex Pharmaceuticals, accusing the company of misleading regulators into closing a case over access to its cystic fibrosis drug Trikafta. While Vertex struck a deal last year to supply the high-priced medicine via select private insurers and a patient assistance program, STAT's Ed Silverman writes, critics say the arrangement still excludes most patients.

"Vertex is using its monopoly power to bully patients into silence whilst profiteering from their desperation," the chief of an advocacy group said. "This is exactly the kind of abusive conduct our competition laws are designed to prevent."

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