FDA says it’s getting serious about illegal vapes. It’s still likely to get a tongue lashing.

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BIOSECURE might hitch a ride with a key defense bill

Here at STAT we’ve not reported much on the annual National Defense Authorization Act, so it was surprising to learn that more than 1,300 amendments have been submitted to that bill for a House Rules Committee hearing today.

Among them is the biotech national security bill, the BIOSECURE Act, which is getting a lot of attention from the industry.

The Rules Committee dictates which amendments lawmakers are allowed to consider adding to a bill during floor debate. BIOSECURE already has a lot of traction. If the committee rules that BIOSECURE is among the lucky group of amendments germane to the NDAA, that would be another sizable step toward the biotech bill becoming law, according to my colleague John Wilkerson. Congress has reliably passed the NDAA each year for several decades.

The biosecurity legislation loomed large over this year’s BIO conference, as my colleagues Jonathan Wosen and Meghana Keshavan reported last week. Some biotech execs told STAT that they’re actively looking to strike deals with U.S.-based drug manufacturers rather than companies named in the legislation; others said business has gone through the roof. Read more from Jonathan and Meghana about the climate at BIO.

The FDA says it’s getting serious about illegal vapes. It’ll still likely get a tongue lashing later this week.

The FDA announced Monday that it will be working with the Department of Justice and some of this countries’ most powerful law enforcement agencies, namely the Bureau of Alcohol, Tobacco, Firearms and Explosives and the U.S. Marshals Service, as part of a new task force to combat the continued sale of illegal vapes, my colleague Nick Florko reports.

The announcement would seem a prudent, albeit intimidating, step to address both the vape shop and convenience store industry’s unwillingness to pull illegal vapes off of shelves, and the international vaping industry’s unwillingness to stop shipping illegal vapes into this country. So why now? We at D.C. Diagnosis can’t help but notice that the announcement comes just days after Congress’ most outspoken critic of the the FDA’s vaping strategy, Sen. Dick Durbin, announced a hearing about the lack of enforcement against illegal vapes.

In a statement Monday, Durbin made clear that while the announcement is welcomed, he’s still more than a little displeased about all the illegal vapes that currently line store shelves. “New partnerships only matter if our federal agencies use their enforcement tools instead of cowering to the tobacco industry’s lawyers,” Durbin wrote. “Thus far, our agencies have failed to prevent a wave of youth e-cigarette addiction.”

A Durbin spokesperson confirmed to STAT that officials from both FDA and DOJ will be participating in the hearing, which is being held by the Senate Judiciary Committee and is slated for Wednesday morning, so stay tuned to see just how heated it gets. In the meantime, shoot Nick a note if you have thoughts on what actor would play Robert Califf in a Michael Mann-style international crime drama about the efforts to take down the Chinese vaping industry one corner store at a time.

Explaining the SCOTUS decision on Indian tribes’ health care

The Supreme Court delivered its first batch of opinions last Thursday. The big ones we’re waiting on — like the fate of mifepristone access and regulatory agencies’ authority over industry — are still looming, but one of last week’s decisions could put HHS’s budget in a bind.

The court ruled 5-4 in Becerra v. San Carlos Apache Tribe that the agency is required to cover Indian tribes’ administrative expenses when they provide health care services outside directly funded Indian Health Service clinics. This reimbursement route, known as the 638 pathway, has become increasingly common for tribal governments, especially when setting up rural clinics, said Mike Andrews, a McGuireWoods consultant with a long history at the Senate Committee on Indian Affairs. The decision opens the door for not just the Apache tribe but more than 340 others across the continental U.S. to bill administrative costs to HHS

The problem: There aren’t new funds to buoy those payments coming anytime soon. President Biden requested $8.2 billion in his 2025 budget and asked Congress to shift the IHS budget from discretionary to mandatory funding, as HHS highlighted in a statement on SCOTUS’ decision. But because of Congressional tweaks in 2022 — which put IHS on a two-year funding cycle — it could be 2027 before IHS receives significant additional funds to meet new demands.

SCOTUS takes up DSH payment case

Speaking of the highest court, the justices agreed Monday to hear a lawsuit by more than 200 hospitals in 32 states who argue that Medicare rules for hospitals serving low-income populations are shorting them roughly $1.5 billion a year.

The so-called disproportionate share hospitals argue that Medicare’s funding calculations bypass paying for a number of low-income patients by only factoring in those who were on supplemental security income benefits while they were in the hospital, regardless of whether other patients were eligible for the federal program.

A D.C. Circuit court decided in favor of the federal government. But the case has parallels with 2022’s AHA v. Becerra, in which SCOTUS sided with hospitals on 340B program drug payments. It could also be yet another chance for the court to squeeze the so-called Chevron doctrine, which means generally deferring to regulators on their industry authority.

Inside the FDA’s MDMA debacle

Last week’s FDA advisory meeting on an MDMA-assisted therapy to treat PTSD got heated. The panel heard from regulators who said the company, Lykos, failed to follow agency instructions to lay out the drug’s benefits and addiction potential. Company executives said they misunderstood the directives; STAT’s Olivia Goldhill dove into what really happened.

Olivia spoke with former employees who told a different story. They said the company was disorganized and that hype for the product overtook rigorous scientific processes. Some expressed relief that the advisory committee asked in-depth questions about patient safety and data integrity.

Lykos told STAT it stands by its studies and that those accusations were unfounded. But the committee’s skepticism could spell a setback for psychedelic drug approvals and future research. Go behind-the-scenes with Olivia.

And stay tuned: Speaking of advisory committees, FDA slated a meeting Thursday to debate their future role.

What we’re reading

• Medical device trials still don’t enroll enough women, study finds, STAT
• Nursing homes are left in the dark as more utilities cut power to prevent wildfires, KFF Health News
• Moderna says data show its combination Covid-flu vaccine generates a strong immune response, STAT
• Accusers’ bad math: NIH researchers didn’t pocket $710 million in royalties during pandemic, Science