Trump administration rehires some FDA workers

The Food and Drug Administration has begun quietly rehiring some of the employees it fired earlier this month, under the direction of Elon Musk and the U.S. DOGE Service.

While the total number of employees rehired is unclear, in at least some cases the reinstatements appeared to be broad, STAT's Lizzy Lawrence reports. All 12 workers who were fired from the surgical and infection control devices office were re-hired, for instance, as were a handful of employees reviewing AI-enabled imaging devices, diabetes devices, and cardiovascular devices.

Several of those re-hired received an email saying that "an exception to retain you has been granted by leadership."

covid-19

Preliminary vaccine study fuels online controversy

A preprint theorizing that Covid-19 shots might be linked to a condition being dubbed "post-vaccination syndrome" has ignited an online storm.

The researchers behind the study, Yale immunologist Akiko Iwasaki and Yale cardiologist Harlan Krumholz, emphasized that the work is preliminary. "I just saw people suffering and thought we should follow the science," Krumholz told STAT's Helen Branswell. "I don't think it's ready to be used in clinical decision-making."

However, anti-vaccine activists are using the research to further challenge vaccine safety and fuel political debates. "We tried to warn you. This is completely horrifying," one right-wing influencer wrote on X.

drug pricing

Maryland lawmakers advance bill expanding mandate for drug affordability board

The Maryland House of Delegates has voted to allow a state board to extend its mandate for lowering prescription drug costs to all residents, not just those employed by government agencies.

"It's time to act to make drugs more affordable for all. Big drug corporations are making enormous profits and spending lavishly on advertising, even as many people struggle to pay for the prescriptions they need to live healthy lives," said Vincent DeMarco of the Maryland Health Care for All coalition. "This bill will help fix that, and we urge the Senate to approve the bill and for Governor Moore to sign it."

The state's Prescription Drug Affordability Board is meant to regulate drug prices as a utility commission might. Maryland joins several states pursuing affordability boards, as pressure intensifies for solutions to the rising cost of medicines.

regulatory

FDA approves first drug for rare lipid storage disease

The FDA has approved Ctexli, or chenodiol, as the first treatment for a rare genetic disorder called cerebrotendinous xanthomatosis, which impairs fat metabolism and can lead to abnormal cholesterol deposits in multiple organs. Two years ago, Mirum Pharmaceuticals paid $210 million to Travere Therapeutics to acquire its bile acid portfolio — which included this drug, chenodiol.

Chenodiol has been approved already for decades to treat gallstones. This means that patients with this disease have already been able to access chenodiol off-label for years, FiercePharma points out.

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