RFK Jr. and vaccines, FDA drug reviews threatened

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Good morning, Jason Mast here filling in for Rose. Yesterday, STAT won a National Magazine Award for General Excellence. Judges for the award, one of the highest in American journalism, specifically wrote that STAT “uncovered the ongoing tragedy of sickle-cell patients pressured into sterilization; relentlessly documented the way UnitedHealth Group gobbled up healthcare providers to create a vast network of profit-maximizing patient mills; and showcased a life-saving solution hiding in plain sight in an exposé on medical opioid treatments.”

Drug reviews threatened

The Trump Administration’s sweeping FDA layoffs were supposed to spare its core functions, leaving drug reviews and inspections in place. It doesn’t seem that’s quite gone according to plan. 

More than a dozen current and former employees told STAT that drug reviews are likely to be impacted by the so-called reduction-in-force. The issue is that, even if reviewers were spared, the layoffs hit a broad suite of workers who provided critical support for drug reviews or did other key tasks to shepherd drugs through the regulatory process. 

People who facilitate advisory committees are gone. So are policy experts who release guidance that generic drugmakers rely on to develop cheap medicines that drive down prices. And reviewers themselves are leaving amid the stress and turmoil. In a concession to seemingly stem the bleeding, the agency  — which had been trying, with chaotic results, to bring every employee into the office — said it would allow employees to work two days per week from home. Read more from Lizzy, Elaine and Matt.

RFK Jr.’s latest theory about vaccines

Health Secretary Robert F. Kennedy Jr. has a lot of unorthodox ideas about vaccines, some of which experts have spent years painstakingly discrediting. But this week, he unveiled a new one: The idea that respiratory vaccines targeting only one portion of the pathogen don’t work.

Kennedy made the claim during an interview with CBS News, when pressed on why political appointees at the Food and Drug Administration delayed granting full approval to Novavax’s Covid-19 vaccine, which is currently under emergency use authorization. His proclamation caught experts off guard. “He’s wrong,” Paul Offit, the prominent vaccinologist at Children’s Hospital of Philadelphia told STAT’s Helen Branswell. 

The original Covid-19 shots targeted a single protein and proved highly effective. The same is true for a new class of vaccines aimed against RSV. Kennedy’s stance, while unfounded, could have significant implications for the development of new vaccines. Read more from Helen.   

One small step for mousekind?

The FDA said in a press release yesterday that it would replace or limit animal testing requirements for starting human trials of antibodies and certain other drugs, if there are good alternative ways of modeling their safety in the lab. Those could include AI-based computational models of toxicity, as well as testing in miniature lab-grown organoids. The agency will also rely on real-world evidence from other countries when available to make evaluations on efficacy. 

The move appears to be part of a years-long effort to spare our rodent cousins the ravages of drug development whenever possible, first instituted with the FDA Modernization Act 2.0 passed in 2022. 

It’s never a good day to be a lab rat, but today, it’s a slightly less bad day. And it’s a terrible day to be a stockholder of Charles River Labs, the company that conducts animal studies for much of the pharmaceutical industry. Its stock plummeted nearly 30% in about 30 minutes Thursday afternoon.

HHS rejects gender dysphoria update to disability law

The Department of Health and Human Services will issue a ruling Friday morning that could upend a lawsuit against a key disability law.

In November, Texas and 16 other states filed a suit arguing that the Biden administration adding gender dysphoria to the Section 504 of the Rehabilitation Act of 1973 was unconstitutional. Friday’s rule clarification essentially strikes down this update, which lawyers say will render the suit moot. But experts are unclear how states will proceed because the suit’s language is broad enough to include Section 504’s integration mandate, which has helped shift the community’s health care from institutions to community settings. (More info in this Q&A.)

We should have more clarity on April 21, when the states provide their next update and reveal their hand on whether they are only interested in striking down protections for trans people or if they will seek to disrupt life for millions of disabled people. — O. Rose Broderick

What happens with USAID gone?

The Trump Administration’s  decision to dismantle the United States Agency for International Development, or USAID, has left an enormous vacuum. The 64-year-old agency employed 14,000 aid workers, providing food and other critical aid to nearly 180 countries. No one country or entity can fill that gap, writes STAT contributor Arjun Sharma. But collectively, “the rest of the world’s wealthy nations must work together to take its place.”

Sharma, an infectious diseases physician at the University of Toronto, points to a 1970 World Bank report proposing that developed countries spend 0.7% of their gross national income on aid, a benchmark then adopted by the U.N. Most countries still fall far short, and if donor nations actually spent that, global aid would almost double. Even the U.S. was only spending 0.24% before gutting USAID. “If foreign assistance is viewed for its collective benefit — to security interests, humanitarian values, and public health — it is best to understand it, perhaps, as a collective obligation,” Sharma writes. 

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