Morning Briefing
Summaries of health policy coverage from major news organizations
Justice Department Not Privy To Private Trans Patient Data, Judge Rules
A federal judge has blocked the Trump administration’s sweeping demands for confidential transgender patient information from Rhode Island’s largest hospital that provides gender-affirming care to minors. U.S. District Judge Mary McElroy’s Wednesday ruling is the latest setback for the U.S. Department of Justice, where at least seven other federal courts have agreed to quash or limit the expansive civil subpoenas sent to more than 20 doctors and hospitals last summer. (Kruesi, 5/14)
The Justice Department sent a letter to Yale School of Medicine on Thursday, alleging it was illegally discriminating against applicants who are not Black or Hispanic, following a similar missive sent last week to the University of California, Los Angeles medical school. (Oza, 5/15)
Regarding the U.S. Food and Drug Administration —
Stakeholders across the board are calling for a return to regular order at the FDA following the resignation of Commissioner Marty Makary, MD, MPH, who said he resigned in protest over the agency's decision to authorize flavored e-cigarettes. At a Future of Health Summit on Wednesday, Stephen J. Ubl, president and CEO of Pharmaceutical Research and Manufacturers of America, said, "I think what we really need from the next leader of the FDA is to calm the waters and re-establish that certainty and predictability." (Firth, 5/14)
ýҕl Health News: FDA Blocked Melanoma Drug As Confusion Reigned Under Makary
The FDA’s recent decision to withhold approval of a new skin cancer treatment fell like a hammer on doctors who treat melanoma and patients who saw that the drug had prolonged the lives of a third of the participants in a clinical trial. “It was devastating news,” said Trisha Wise-Draper, a dermatologist at the University of Cincinnati who had patients enrolled in the trial.“ This is life or death for maybe 2,000 patients,” added Eric Whitman, medical director of the Atlantic Health System’s oncology service. A Wall Street Journal editorial assailed the ruling, noting that it “will have a chilling effect on drug development.” (Allen, 5/15)
ýҕl Health News' ‘What The Health?’ Podcast: In Search Of A New FDA Commissioner
As had been rumored for weeks, Marty Makary is out as commissioner of the FDA after a chaotic 13 months presiding over drama in every corner of the agency. That leaves Robert F. Kennedy Jr.’s Department of Health and Human Services with three senior vacancies: FDA commissioner, surgeon general, and director of the Centers for Disease Control and Prevention. All must pass through the Senate committee chaired by Sen. Bill Cassidy (R-La.), who has had a troubled relationship with Kennedy and President Donald Trump. (Rovner, 5/14)
The FDA on Wednesday approved a new all-oral regimen for newly diagnosed acute myeloid leukemia (AML) in patients ineligible for intensive chemotherapy. (Ingram, 5/14)
More news from the Trump administration —
The U.S. Environmental Protection Agency moved Thursday to roll back limits that require coal-fired power plants to prevent the release of toxic heavy metals into streams and rivers through polluted groundwater, saying a three-year-old rule is unduly costly for the energy industry at a time when energy demand is spiking. It is the latest step that President Donald Trump’s administration has taken to pull back regulations on coal mining and coal-fired power and empower fossil fuels as a primary energy source to feed the rapid growth of artificial intelligence data centers. (Levy, 5/14)
Over a recent breakfast, U.S. officials had a message for the German ambassador: pay more for pharmaceuticals. The meeting, between U.S. Trade Representative Jamieson Greer, chief health department adviser Chris Klomp, and German Ambassador Jens Hanefeld, was part of a larger push from the Trump administration to get other countries to pay more for medications as the U.S. pays less, according to a person familiar with the meeting. (Payne, 5/15)
ýҕl Health News: Kennedy, Balancing MAHA And White House, Says He Won’t Run For President In 2028
Health and Human Services Secretary Robert F. Kennedy Jr. is caught between his Make America Healthy Again supporters who want him to do more to advance their priorities, including curtailing vaccines, and a White House trying to combat President Donald Trump’s unpopularity. (Armour and Seitz, 5/15)
U.S. President Donald Trump’s decision last year to abruptly dissolve the U.S. Agency for International Development — once a leading global aid donor — has been followed by a significant increase in violence in several African countries that the agency had supported, according to a study published on Thursday. While the authors did not blame the USAID cuts for the increase in violence, they said the findings demonstrate that “large-scale, sudden aid cuts can destabilize fragile settings.” They, however, added that this is not evidence that more aid reduces conflict, instead it only shows “the effect of a sudden and unexpected disruption.” (McMakin, 5/14)
As part of efforts to phase out the use of monkeys in research, the Centers for Disease Control and Prevention intends to transfer more than 160 macaques to Born Free USA, a nonprofit that runs a large primate sanctuary in Texas. (Silverman, 5/14)
Updates from Capitol Hill —
A bipartisan group of lawmakers in both chambers of Congress has reintroduced a bill aimed at barring companies from owning both a pharmacy benefit manager and retail pharmacies. The bill, called the Patients Before Monopolies (PBM) Act, would force conglomerates that include a PBM to divest pharmacies that they own. The legislation has existed in some form since 2024, and since its first introduction, Arkansas has implemented a similar legislation at the state level. (Minemyer, 5/14)
Reps. Don Davis (D-N.C.) and Claudia Tenney (R-N.Y.) said Thursday the House is prepared to pass legislation supporting wider access to genetically targeted technologies (GTTs) that can treat conditions like heart disease, with the current challenge of getting it on the “front burner” in the Senate. Appearing at The Hill’s “Protecting Patients from America’s No. 1 Killer” event, sponsored by the Partnership to Advance Cardiovascular Health (PACH), Davis and Tenney discussed their bill titled the Maintaining Investments in New Innovation (MINI) Act, which would legislate when genetically targeted technologies can be eligible for Medicare drug price negotiation. (Choi, 5/14)
Senators unanimously approved a resolution Thursday to withhold their pay during government shutdowns, an attempt to make federal closures financially painful for lawmakers after a string of record-breaking impasses in the past year. The bipartisan support for the measure comes at a time when federal closures have become longer and more frequent, frustrating lawmakers who say there should be punishment when Congress fails at its most basic legislative duty. (Cappelletti and Jalonick, 5/14)