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Mifepristone’s day in (Supreme) Court

March 26, 2024
Reporter, D.C. Diagnosis Writer

Hello and happy Tuesday, D.C. Diagnosis readers! When hot health care topics and limited airtime collide. Speaking of hot topics, be sure to subscribe to my colleague Adam's new newsletter, the Biotech Scorecard. And as always, send news, tips, and the good, bad and ugly tweets to sarah.owermohle@statnews.com.

Reproductive rights

The wide-ranging mifepristone arguments 

This morning, I'll be at the Supreme Court reporting firsthand on opening arguments in the Alliance for Hippocratic Medicine's efforts to reverse the FDA's relaxed restrictions around mifepristone, the commonly used abortion pill. 

The court's decision — expected this summer — could deal yet another blow to reproductive rights across the country, but industry warns it won't stop there. A verdict sidestepping the FDA could throw the entire regulatory process into "disarray," said one pharmaceutical executive.

PhRMA and BIO, which did not initially get involved in the lawsuit, are voicing the same concerns in briefs filed with the court, arguing that a court decision reversing one or two of the FDA's regulatory decisions could make all of the agency's work susceptible to legal challenges. That makes particularly controversial and politicized products, like Covid-19 vaccines and gender-affirming medicines, especially vulnerable.

Besides questioning the agency's decisionmaking, justices are likely to also interrogate the plaintiff's argument that increased mifepristone access endangers them as health care practitioners. At stake, abortion advocates argue, is a provably safe and widely used method of abortion — and many of them are expected to show up outside the court this morning. More from me to get ready for this day's arguments.


food regs 

What really is meat?

The Department of Agriculture is inching closer to laying out its rules for how producers of lab-grown meat should label their products, my colleague Nick Florko writes. The USDA submitted a proposed rule for White House review late last week, meaning a proposed regulation is likely just around the corner. 

For the uninitiated: The debate centers on the question of whether meat grown from stem cells of a living animal can be called meat — a legal and philosophical question that has prompted some very, very strange research, including a "meat science lexicon" from the American Meat Science Association.

Interestingly, the two sides of the debate aren't that far off in their preferred solutions. Both the traditional-meat and lab-meat industries tend to agree that these products shouldn't simply be called "meat." But where the two sides disagree is on what descriptor to actually tack onto the m-word. The National Cattlemen's Beef Association prefers the term "lab-grown," but that isn't flying with the alternative meat industry, which argues the term is "intended to be derogatory" and doesn't apply to other foods produced in similar ways. "Beer is not referred to as 'lab-grown beer,'" a coalition of alternative meat companies wrote in recent comments to USDA. The coalition instead prefers the term "cultivated meat."

There's no telling yet what the USDA will do, or how it will tackle even more complex – and stomach-turning – questions, like how to label products made from an amalgam of both slaughtered and lab-grown meat.


War on Recovery 

A Swiss look at methadone access 

American methadone clinics argue that keeping the addiction treatment squarely inside their jurisdiction is a necessary safety precaution. Addiction experts in Switzerland, where the opioid death rate is roughly one-twentieth of the U.S.'s, disagree.

At Arud Centre for Addiction Medicine, one of the clinics Lev Facher visited during his yearlong War on Recovery investigation, patients in need of addiction care are given instant access to weeks' worth of medication. They are not required to participate in counseling, or subjected to drug tests, or punished if they relapse and use illicit substances. It is a strategy that American methadone clinics warn would result in disaster — but that European experts say is the continent's key to success. 

Some critics argue that Switzerland and other wealthy nations that have adopted similar models simply aren't comparable to the U.S. health system and its challenges. Nevertheless, American attitudes do seem to be shifting: The NIDA director in 2022 said she believes physicians should be able to prescribe methadone directly, and a coalition of lawmakers is pushing legislation to that effect. More from Lev.



obamacare wars 

The ACA's birthday isn't happy for everyone

Obamacare is 14 years old. What once was a political hot-button for Democrats to defend — especially from repeated repeal attempts — is well, still that. But while most Democrats spent this past week touting record enrollment rates and using President Trump's promises for another repeal effort as political fuel, some allies are griping. 

"It's way past time to repeal the so-called 'Affordable Care Act,' replace it with Medicare for All, prevent 68,000 Americans from dying each year because they can't afford healthcare and cancel the medical debt of 100 million Americans," Warren Gunnels, the top HELP staffer for Sen. Bernie Sanders (I-Vt.), tweeted.

Republicans meanwhile warn that high enrollment is not a panacea but simply a product of unsustainable federal subsidies to keep enrollee's spending low. Biden is looking to make those subsidies permanent in the 2025 spending bill, but — stop me if you've heard this before — the ACA's fate is shaping up to be a sharp election year issue.


medicare advantage 

MA insurers press for bigger payouts

Biden's final Medicare Advantage payment rules for 2025 come out by April 1. The public will soon find out whether the federal government is willing to meet the health insurance industry's demands and deposit more money into the bank accounts of next year's plans, Bob Herman writes.

CMS in February proposed a modest cut to next year's average benchmark payments, but insurers are still estimated to receive more money under the proposal, overall, due to the aggressive way they code the medical conditions of their members.

The government usually increases that growth rate in the final rules, and top Medicare officials have already said it will be "updated" once they analyze more recent data from the end of 2023. Insurance companies are telling the Biden administration that it better not stray from that commitment and that it must finalize a payment rate that fits with their own data. More from Bob.

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What we're reading

  • Despite new Wegovy coverage, Medicare patients may face high drug costs and other hurdles, STAT
  • Former Justice Stephen Breyer: It's 'possible' Dobbs could be overruled one day, NBC News
  • Opinion: What the public might learn from Kate Middleton, the latest 'famous patient', STAT
  • How a for-profit health system's push to expand ended in disappointment for a tiny island nation, The Boston Globe

Thanks for reading! More on Thursday,


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