What a SCOTUS vape decision means for the FDA

The Supreme Court heard arguments Monday over the FDA's decision to block certain flavored vapes from the market. The court's eventual decision could change the way the agency regulates not just vaping products, but a litany of other products under its purview, as STAT's Lizzy Lawrence notes.

Two e-cigarette makers sued the agency after their applications were denied in 2021. A lower court ruled against the FDA in January, taking issue with the agency saying it is not bound to statements made in its guidance documents.

It's that aspect of the case that could shape the agency's actions in the future. If the Supreme Court upholds that decision, the FDA may release fewer guidance documents in tobacco regulation and beyond, Lizzy writes. More from her on the arguments before the court and what they mean for the FDA.

LGBTQ policy

Gender-affirming care before SCOTUS

The Supreme Court on Wednesday will hear arguments on whether Tennessee's ban on gender-affirming care for minors is legal. The case — and the justices' eventual decision — could have huge ramifications for President-elect Trump's plan to nationally prohibit this type of care for minors and bar federal funding for transgender care broadly.

It could also easily influence other states' moves in this area. Twenty-six states have enacted limits on gender-affirming care, particularly for minors. Most of those states have conservative legislatures and governors, but not all: Kentucky's Democratic Gov. Andy Beshear vetoed the law before the GOP-led state legislature overrode him, and it's volleyed through courts since. The court's ruling on U.S. v. Skrmetti would influence those court battles as well.

Plaintiffs including one Tennessee teen argue that these laws violate transgender minors' equal protection rights and endanger their health. While the incoming Trump administration isn't party to this case, Trump promised during his campaign that on "day one" he'd order federal agencies to "cease the promotion of sex or gender transition at any age."

STAT's Therese Gaffney and I will be covering the arguments on Wednesday; be sure to follow along.

covid response

Covid committee's sprawling report sets up for potential reform

The House Select Subcommittee on the Coronavirus Pandemic is wrapping up a roughly two-year, GOP-led investigation into Covid-19's origins, the federal government's response, and agency oversight of infectious disease research. First step: A more than 500-page report detailing actions at NIH, FDA, and CDC, and where the panel says they went wrong.

The report lays out previous accusations that former NIAID Director Anthony Fauci misled the committee about so-called gain-of-function research and the EcoHealth Alliance, the research group at the center of bipartisan committee probes. It also concludes that then-senior leaders of CDC swept aside independent advisers' guidance when issuing broad recommendations for booster vaccines, masking, and other policies. FDA is questioned, too, for its vaccine approval decisions.

While the report doesn't delve into specific policy recommendations, it does set the stage for health agency reforms, some of which Republican lawmakers and the incoming Trump administration have already proposed. Chair Brad Wenstrup (R-Ohio) also took pains to mention that there are at least a dozen conclusions in the report where both Republicans and Democrats can agree. The committee convenes Wednesday to present the report and, potentially, debate next steps on infectious disease controls and the federal agencies that oversee them.

on the hill

Cyber Monday for Congress: Coverage of GLP-1s is on sale

Lawmakers on Capitol Hill have long cited the hefty price tag of allowing Medicare to cover buzzy anti-obesity medications as the primary reason why the policy hasn't passed. But now that the Biden administration has proposed a regulation to allow coverage, the policy would essentially be on sale for Congress, Rachel Cohrs Zhang reports.

When a regulation is proposed, the Congressional Budget Office updates its baseline budget to include part of the cost of the rule (often 50%, according to CBO). That means if Congress were to pass a law codifying Medicare coverage of anti-obesity medications like Wegovy and Zepbound, the cost estimate could be roughly half off of the normal price tag for the federal government.

Congress is known to play games with budget estimates, given Congress funded significant chunks of the Biden administration's domestic policy agenda by rolling back a Trump-era drug payment rule.

But Congress' window of opportunity may be small, as Robert F. Kennedy Jr. could choose to cancel the rule if he's confirmed as HHS secretary. It's unclear whether there is the will to enact a major coverage expansion in Medicare in the coming weeks.

transition watch

Former Trump official warns against RFK Jr. nomination

Trump's first FDA commissioner, Scott Gottlieb, is raising concerns with Senate Republicans about Trump's selection of RFK Jr. to lead HHS.

Gottlieb maintained during a television appearance on Friday that there is skepticism among Republicans who will vote on his nomination. "I've had conversations, and I've raised my concerns and I will continue to raise my concerns," he said on CNBC.

So far, moderate Republicans have held back from saying whether they will support RFK Jr.'s nomination. Given the Republican majority in the Senate next year, the former environmental lawyer would have to lose four Republican votes and fail to sway a single Democrat in order for his nomination to fail, Rachel notes. More from her.

drug pricing

Study: Medicare negotiated prices, by the numbers

Medicare's first batch of negotiated drug prices have some pretty varied savings, according to an analysis published in JAMA this week. Settled prices for the 10 initial drugs were 8% to 42% lower than their pre-negotiation net prices, researchers from Brown University, University of California San Diego, University of Washington and London School of Economics and Political Science wrote.

Still, the negotiated prices for all but one drug remain above the list prices in peer countries, they said.

While Trump hasn't really touched the Medicare negotiation law launched by President Biden, he has railed against the U.S. paying more for these drugs than peer countries do. Read the whole analysis.

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What we're reading

Private Medicare insurers are likely to benefit in Trump's new administration, STAT
Opinion: Congress' critical opportunity to reshape health care, STAT
How Kennedy has worked abroad to weaken global public health policy, The New York Times
Scientists confront a mystery: Why have U.S. bird flu cases been so mild? STAT