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Unpacking the next battle in the never-ending war over Aduhelm
Despite thousands of letters, plenty of patient pleas, and even a protest outside of the federal health department, Medicare finalized its controversial limits on coverage of Biogen’s Alzheimer’s drug.
Now, it seems, the only way drug makers and patient advocates can reverse this decision is to go to the courts. Biogen and Eli Lilly, both of which would be impacted by Medicare’s decision, have seriously hinted they plan to sue. And that potential lawsuit could challenge not just the Aduhelm decision, but Medicare’s ability to require additional clinical trials writ large.
In a new story for STAT, I unpack the legal arguments drug makers have been rehearsing and answer your most burning questions about a potential lawsuit, including “What the heck happens to Aduhelm if Medicare loses in court?”
Check out my new story here.
While you’re at it:
- Check out my colleague Ed Silverman’s new column detailing the growing fear among drug industry insiders that Medicare officials will use their Aduhelm decision to deny coverage for other drugs approved through the FDA’s accelerated approval pathway.
- Half of the scientific advisory board members for the Alliance for Aging Research resigned after learning the organization had lobbied against a Medicare proposal to restrict coverage of the medication.
- Opinion: CMS made the wrong decision on Aduhelm.
- And, also from Opinion: Medicare got it right.
Are insulin makers committing human rights abuses?
I’ve lost count of the number of reports that have come across my desk in recent years unpacking the causes, and consequences, of high insulin prices in the United States. But none quite caught my attention like this newly published one from Human Rights Watch.
The international advocacy organization argues that when people in the United States can’t afford their insulin because of high prices and shoddy insurance, they’re not just being inconvenienced — they’re experiencing human rights violations.
As I write in a new story for STAT, this report could shape up to be a major PR disaster for insulin makers. After all, it’s not everyday that a drug maker is accused of contributing to human rights abuses by the nonprofit known for investigating warcrimes and genocides.
Check out my new story here.
Speaking of insulin prices: My colleague Rachel Cohrs has the latest on Capitol Hill’s efforts to rein in insulin prices. The bill, Rachel writes, “is likely to disappoint progressives” because it would make lowering insulin list prices optional for drugmakers. And while the bill would cap insulin copays for people with Medicare or private insurance, it wouldn’t extend the same privilege to the uninsured, who often bear the biggest brunt of high insulin prices.
Warren and Grassley are done waiting on the FDA
Sens. Elizabeth Warren and Chuck Grassley, the bipartisan pair responsible for passing a law in 2017 that mandated the FDA make hearing aids available over the counter, are done waiting for the agency to finalize those rules. The duo have a new bill that would mandate that the FDA finalize the massive regulation within 30 days, I scooped.
A sign of their frustration? The FDA isn’t even technically late finalizing the regulation. An FDA spokesperson noted that the agency has until July.
More on the new bill here.
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