Axios Vitals

July 01, 2024
Happy July, Vitals readers. We're officially halfway through the year. Today's newsletter is 1,000 words or a 4-minute read.
1 big thing: Courts become the health policy arena
If courts weren't already exerting outsized influence over health policy, they're much closer to being final arbiters now that the Supreme Court has scrapped the decades-old doctrine that gave the FDA, CMS and other health agencies the power to interpret vague or ill-defined laws.
Why it matters: Judges could get the final say on Medicare payment rates, drug and device regulation and even what constitutes a public health emergency.
The big picture: We've already seen courts shape the rules of the road on matters like access to abortion pills, surprise billing disputes and how certain hospitals access discounted drugs.
- But experts say that Friday's total repeal of the "Chevron deference" doctrine means that the courts, and not the executive branch, will get to interpret ambiguities in laws.
- "This is only going to hasten the trend that we're already seeing" of judges setting aside regulations, said Zachary Baron, director of Georgetown University's Health Policy and the Law Initiative at the O'Neill Institute.
In the short run, the decision will render rulemaking far less predictable, which could have a destabilizing effect on drug and device manufacturing, major health providers and public health efforts.
- It also followed a separate ruling by the high court that weakened agencies' in-house enforcement tribunals, which could have major implications for Medicare and other big public health programs.
Between the lines: Justice Elena Kagan's dissenting opinion laid out some of the potentially strong consequences for health care.
- Medicare payments to hospitals are adjusted based on geographic area. But that "could be as large as a multi-state region or as small as a census tract," Kagan wrote. The ruling takes discretion away from regulators who gather data on the effects of using different definitions.
- The decision also opens the door to a new wave of legal challenges to high-profile political issues like abortion pills and Affordable Care Act preventive services requirements, said Larry Levitt, executive vice president for health policy at KFF.
2. Cosmetics regulation gets a makeover
While FDA discretion took a hit at the Supreme Court, the agency starting today is wielding new powers over makers of lipsticks, shampoos, baby wipes and other cosmetic products that account for more than $40 billion in sales annually.
Why it matters: It's part of the phase-in of a 2022 law that calls for more oversight of adverse events and requires companies to clearly label allergens, register their facilities and disclose every product they sell.
The big picture: The Modernization of Cosmetics Regulation Act, or MoCRA, aimed to bring more transparency to an opaque industry that was largely self-regulated.
- It took effect at the end of last year and bestowed on authorities the power to recall a cosmetic product and to make companies report serious adverse events, from hair loss to birth defects.
- The agency extended the deadline for companies to register their products and facilities to today. Facilities will have to renew registrations every two years, and companies must initially list each marketed cosmetic product and provide updates — for example, if a product is discontinued.
Between the lines: Some companies likely have reformulated or will soon change the composition of products as the result of the law, Katlin McKelvie, a partner with law firm Gibson, Dunn and Crutcher recently told the Glossy Beauty Podcast.
3. Walgreens' retreat could grow pharmacy deserts
Walgreens' plans to pare back what it calls a "significant portion" of its 8,600 locations will likely worsen the pharmacy shortage in underprivileged communities already struggling with access to care.
Why it matters: Instead of transforming how health care is delivered, retailers' retrenchment from primary care could exacerbate health disparities and bodes ill for poor patients who already are less likely to refill prescriptions.
Catch up quick: During a gloomy earnings call last week, Walgreens CEO Tim Wentworth acknowledged concern about growing pharmacy deserts, noting that his chain is the last company standing in a lot of places.
- The closings come on top of Walgreens' decision to scale back its stake in primary care company VillageMD and close 160 clinics across the country and another round of U.S. store closings last year.
Between the lines: The rollbacks have sparked protests over the effects on low-income neighborhoods and communities of color.
- Massachusetts Democratic Sens. Ed Markey and Elizabeth Warren and Democratic Rep. Ayanna Pressley grilled Wentworth about it earlier this year.
- Wentworth said the chain's goal is "not simply to be the last one to leave," adding that the company plans to work with state Medicaid programs and local law enforcement to continue to provide care.
4. Critical chemo drug no longer in shortage
Supplies of the widely used chemotherapy drug cisplatin now exceed demand, ending a national shortage that shook cancer care and highlighted supply chain vulnerabilities, especially for sterile injectables.
Why it matters: While it's encouraging news for patients, ongoing shortages of other drugs are driving a debate over reliance on overseas manufacturing and FDA authority.
Driving the news: FDA Commissioner Robert Califf announced Friday that the cisplatin squeeze had ended and that the agency is working with drugmakers and other players along the supply chain to address shortages of other cancer treatments.
- The shortages have led doctors to ration care, ask patients to drive long distances for treatment, or turn to alternative treatments with riskier side effects.
- This particular one began when an FDA investigation prompted an Indian manufacturer that makes about half of the cisplatin used in the U.S. to suspend the production of the drug because of concerns over the quality, per NBC News.
Among the questions it touched off is whether regulators need more authority to order manufacturers to report shortages, or to order stockpiling.
5. While you were weekending
🏛️ Texas' Supreme Court upheld a state law barring doctors from prescribing gender-affirming care to transgender minors. (Texas Tribune)
❌ The Iowa Supreme Court ruled that the state's six-week abortion ban could be enforced, sharply limiting access to the procedure. (NYT)
🥼 Optum called off a plan to acquire financially troubled Steward Health Care's 1,700-physician group. (Becker's ASC Review)
👀 Could the effects of cold medicines explain President Biden's jumbled debate performance? (Newsweek)
Thanks for reading Axios Vitals, and to senior health care editor Adriel Bettelheim, managing editor Alison Snyder and copy editor Matt Piper. Please ask your friends and colleagues to sign up.
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