Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Head Makary Resigns; Top Food Official Diamantas Stepping In
Politico: Makary’s Time Atop FDA Over, Diamantas Named Acting Commissioner
Marty Makary’s nine lives atop his agency are over. The embattled Food and Drug Administration commissioner is resigning from his role Tuesday after 13 months leading the federal agency, according to an administration official granted anonymity to discuss the development. Kyle Diamantas, who previously worked as the top food official at the agency, will lead the FDA in an acting capacity, the administration official said. (Lim and Gardner, 5/12)
AP: Trump’s FDA Chief Is Out After Angering Pharma CEOs, Vaping Lobbyists And Anti-Abortion Activists
The head of the Food and Drug Administration, Dr. Marty Makary, is resigning after a rocky tenure that drew months of complaints from health industry executives, anti-abortion activists, vaping lobbyists and other allies of President Donald Trump. News of Makary’s departure Tuesday came just 13 months after he was confirmed to lead the powerful regulatory agency. (Perrone and Min Kim, 5/13)
The 19th: FDA Commissioner Marty Makary's Exit Could Threaten Abortion Access
Food and Drug Commissioner Marty Makary’s planned resignation creates a new opening for anti-abortion activists to push for national restrictions on the procedure — and in particular, limit the availability of a key abortion drug. The move comes as anti-abortion groups became angry over what they viewed as his agency’s failure to curb access to the drug. (Luthra and Rodriguez, 5/12)
Updates from the U.S. Food and Drug Administration —
Fox News: FDA Approves First Non-Antipsychotic Drug For Alzheimer's Agitation
The U.S. Food and Drug Administration has green-lit the first-ever non-antipsychotic drug treatment for agitation in Alzheimer’s disease patients. The drug, Auvelity, was originally FDA-approved in 2022 for treating adults with major depressive disorder. Most recently, its use has been expanded for agitation associated with dementia. Agitation is a common and "distressing" symptom in adults with Alzheimer’s, according to the agency. The condition is characterized by excessive motor activity, or verbal or physical aggression. (Stabile, 5/12)
CIDRAP: FDA Clears First AI-Based Early Warning System For Sepsis
The Food and Drug Administration (FDA) has cleared an artificial intelligence (AI)-based sepsis detection system for approval. The Targeted Real-Time Early Warning System, developed by researchers at Johns Hopkins University and commercialized by Bayesian Health, integrates electronic health records with advanced clinical AI to continuously monitor patients and flag sepsis up to 48 hours before a clinician suspects it. A 2022 study of more than 764,000 patient encounters at five US hospitals found that when clinicians acted on the tool’s alerts, sepsis patients were 18% less likely to die in the hospital. (Dall, 5/12)
More from the Trump administration —
KFF Health News: Trump And Kennedy Seek To Relax Safeguards For AI Healthcare Tools
Paul Boyer, a psychotherapist for Kaiser Permanente in Oakland, California, is experiencing the AI revolution firsthand. He’s a little underwhelmed. The health giant has rolled out a new suite of note-taking software, made by healthcare AI pioneer Abridge, intended to summarize a patient’s visit at supersonic speed. For many clinicians, the technology soothes one of the persistent headaches of their lives — administration and paperwork. But the AI scribe caused another headache for Boyer and his colleagues: It is “not super useful.” They end up correcting the computer-written notes. (Tahir, 5/13)
MedPage Today: Experts Question Impact Of Trump's Latest Effort On Fertility Care Coverage
The Labor Department's proposed rule to make it easier for employers to offer a fertility benefit isn't likely to result in many more employers doing so, although it may tip the scales for employers who were already considering it, experts said. "The proposal mostly changes the ease of offering, not the economics of fertility treatment itself," Paul Fronstin, PhD, director of health benefits research for the Employee Benefit Research Institute, said in an email to MedPage Today. (Frieden, 5/12)
KFF Health News: RFK Jr. Swaps Vaccine Talk For Healthy Foods And Reading To Tots In Push To Woo Voters
The little boy, dressed in a Toy Story sweatshirt, wrapped himself around the nation’s health secretary. “What do you guys want to be when you grow up?” Health and Human Services Secretary Robert F. Kennedy Jr. asked a carpet full of preschoolers. “A dinosaur!” the boy replied, squeezing tighter. Just weeks ago, Kennedy sat before lawmakers on Capitol Hill and faced intense questions about a dangerous uptick in infectious diseases among American children. Now, with midterm primaries underway, Kennedy was seated in a toddler-sized chair in Ohio, on a mission to change the subject. (Seitz, 5/13)
