Justice Samuel Alito’s order Monday allows women seeking abortions to continue obtaining the pill at pharmacies or through the mail, without an in-person visit to a doctor. It prevents restrictions on mifepristone imposed by a federal appeals court from taking effect for the time being.

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The Court of Justice of the Andean Community — a tribunal that settles trade, intellectual property, and labor disputes for Bolivia, Colombia, Ecuador, and Peru — also ruled that the Colombian government had properly justified the reasons for issuing a license and appropriately set an expiration date for its license.

“The court concluded that Colombia did not incur a breach of Andean regulations, since such measures are valid when there are reasons of public interest,” the health ministry said in a statement. “Colombia adequately complied with the obligation to determine the duration of the compulsory license” for the medicine, which is sold by ViiV Healthcare.

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“We’re looking very seriously at natural 7-OH and getting that approved,” Trump said. 

It was not clear what Trump meant by “natural 7-OH.” Small amounts of the compound, shorthand for 7-hydroxymitragynine, occur naturally in kratom, which is increasingly used as a recreational drug and an unapproved pain treatment. While kratom is significantly less dangerous than potent synthetic opioids like fentanyl or prescription pain pills, it can still cause addiction and overdose. 

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Did you know the U.S. Mint requires gold coins to be made with American-made gold, but instead it gets illegally mined gold that can be traced back to a Colombian drug cartel? Truly mind-blowing stuff from this New York Times investigation. Let me know what the health care angle is on that one: bob.herman@statnews.com.

It’s tough to make predictions, especially about the future

Two years ago, my old pal Rachel Cohrs Zhang and I reported how Medicare’s actuaries predicted the new Alzheimer’s drug Leqembi would cost the program $3.5 billion in 2025. It turns out that prediction was way off.

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The FDA has a significant backlog of applications from the makers of vapes and nicotine pouches seeking authorization to sell their products. Some have gone ahead and put their products on sale anyway while awaiting word from the agency. In the new guidance, first reported by the New York Times, the agency said it will not prioritize cracking down on illegal sales under two conditions.

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There’s fresh turmoil at the very top of the FDA: All weekend, questions have swirled over whether Commissioner Marty Makary will be ousted.

Also, we have a resurrected gene therapy effort in a once-devastated rare disease program, and underwhelming Alzheimer’s drug adoption. 

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People on Medicare are not getting the recently approved Alzheimer’s medications nearly as much as federal officials anticipated, STAT reports. Uptake for the drugs, Leqembi and Kisunla, has been so muted that Medicare is not forecasting significant spending on them in 2026 or 2027, which is a dramatic shift from two years ago, when the agency projected it would spend billions of dollars annually on Leqembi alone. The lower-than-expected spending lines up with the challenges that the Alzheimer’s drugs have faced since their approvals. The intravenous medications are not easy to administer and require a lot of imaging; the population of eligible patients is limited; and the drugs continue to have little meaningful benefits while carrying a risk of severe side effects like brain bleeding.

While doctors and patients report difficulties getting certain doses of estrogen patches, the U.S. Food and Drug Administration has not yet included any on its list of drug shortages, NBC News tells us. The agency removed the black box warning from hormone replacement therapies late last year, and recently, the most insured type, the estrogen patch, has been in short supply amid a boom in the therapy’s popularity. The American Society of Health-System Pharmacists, a professional organization for pharmacists, includes 14 brands or dosages of estrogen patches in its most current list of drugs in shortage. The group first started including estrogen patches on the list in January.

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Good morning and happy Monday. Lots of infectious disease reading today, and some political movement, too. I hope your coffee is ready.

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The four agencies crafting the Independent Dispute Resolution Operations final rule have held 20 meetings — mostly virtual — with industry groups so far this year. Just four of those were with health insurers or their trade groups. Thirteen were with providers or their trade groups, and another three were with other sectors. Stakeholders can request to meet with agency officials to highlight their priorities and submit relevant materials. 

The final rule has been a long time coming. The departments of Health and Human Services, Labor, Treasury, and the Office of Personnel Management released an initial version of the rule in November 2023. The proposed changes include tweaks to how claims can be grouped together, more transparency into pre-arbitration negotiations, and changes to fees.

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The clusters of infections are in some ways reminiscent of the emergence of mpox in 2022 in networks of gay men and other men who have sex with men. But people who have diagnosed some of these dermatophilosis cases describe a disease that is much milder in presentation. 

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Uptake for the drugs, Leqembi and Kisunla, has been so muted that Medicare is not forecasting significant spending on them in 2026 or 2027, a spokesperson for the Centers for Medicare and Medicaid Services told STAT. It’s a dramatic shift from two years ago, when Medicare projected it would spend billions of dollars annually on Leqembi alone.

The lower-than-expected spending lines up with the challenges that the Alzheimer’s drugs have faced since their approvals, neurologists and Medicare experts told STAT: The intravenous medications are not easy to administer and require a lot of imaging; the population of eligible patients is limited; and the drugs continue to have little meaningful benefits while carrying a risk of severe side effects like brain bleeding.

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The board said that it only learned about the pilot after it had launched. Its warning was blunt: proceeding without proper clinical oversight “potentially places Utah citizens at risk.”

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I host a podcast about addiction, where disagreement is part of the job. When I interview someone in recovery, listeners tell me I was too sympathetic to 12-step programs — or not sympathetic enough. When we discuss medications, some argue they save lives; others insist recovery should be “drug-free.”

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So, a few weeks after treatment, it was the first thing Jessica noticed. She jostled Javier, who was asleep in a hospital chair at the National Institutes of Health, awake. When was the last time he had suctioned JJ? An hour had elapsed, they realized, and their boy was breathing fine. 

It was the beginning of a chapter that would prove as bittersweet for the Gonzalezes as it was miraculous. 

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In the midst of a hantavirus outbreak that involves Americans and is making headlines around the world, the U.S. government’s top public health agency, the Centers for Disease Control and Prevention, has been uncharacteristically missing in action, according to a number of experts.

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While Kennedy did not respond to Grijalva about the raccoon incident, focusing instead on the National Institutes of Health budget and DEI, it has been widely treated as sensational news. But the jokes about it obscure an important question: whether his described actions meet fundamental standards of bioethical judgment.

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Torie Bosch: Will Flanary is better known as Dr. Glaucomflecken. He is social media’s most famous comedian slash doctor, and he’s not afraid of punching up.

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The vessel is expected to arrive Sunday at the Spanish island of Tenerife, off the coast of West Africa, and passengers will be taken to a “completely isolated, cordoned-off area,” said the head of Spain’s emergency services, Virginia Barcones.

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The agreement, which is expected to close in the second half of the year, could generate an additional $300 million for PathAI if it leads to the achievement of certain milestones.

“Joining forces with Roche marks a new era for PathAI, enabling us to realize our mission of improving patient outcomes through AI-powered pathology at unprecedented scale and speed,” said Andy Beck, chief executive and cofounder of PathAI, in a statement. “Roche’s global infrastructure and expertise will bring our digital diagnostics technology to patients worldwide.”

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Makary has served in the role for a little over a year. His tenure was ambitious, filled with the announcements of dozens of new initiatives, including efforts to shorten drug review timelines, crack down on misleading ads, and pressure the food industry to remove chemical dyes.

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