fda
Unleashing peptides?
The FDA will convene a panel of outside advisers to discuss whether to let pharmacies compound certain peptides, Lizzy Lawrence and Sarah Todd report.
In 2023, the FDA banned pharmacies from compounding 19 peptides due to evidence of several risks and a lack of safety data. But Kennedy is a fan of peptides, so this July an advisory panel will discuss whether to reverse that decision for seven of them.
Advisory panels don’t meet nearly as much as they used to. With three voting panelists and an industry representative, this one has more vacancies than members (though that could change). Read more to learn about the peptides under consideration.
obamacare
14%
That’s the percentage of Affordable Care Act plan enrollees who didn’t pay their premium in January, according to the actuarial firm Wakely Consulting Group.
After Congress failed to renew enhanced ACA premium subsidies, plan enrollment did not fall as much as might’ve been expected. The nonpartisan Congressional Budget Office projected the individual market would decline by about 20%. January enrollment figures showed a roughly 3% drop.
But regular readers of this newsletter already knew that enrollment is expected to keep falling because those numbers from January only showed how many people chose a plan, not how many paid their premiums. Some enrollees get a 90-day grace period for paying their premium, so a lot more people might drop their insurance this month.
Wakely’s report, first covered by The Wall Street Journal, is the first sign of the true impact of losing those subsidies. The firm projects that average enrollment could shrink 17% to 26%.
We’ll know for sure when the government releases final ACA enrollment data, which the last couple of years has come out in late July.
medicare
NTAP’ed out
For decades, government officials have tried to smooth the path between the authorization of breakthrough medical devices and their adoption by hospitals. They did this in part by paying hospitals a “new technology add-on payment,” or NTAP, for these technologies.
But it hasn’t always worked as planned, and Medicare officials have proposed rolling back that policy, Katie Palmer reports.
The FDA often designates technologies as breakthroughs before much clinical evidence is collected. That means Medicare can end up paying a premium for devices that haven’t demonstrated that they’re better than their predecessors.
Read more.
clinical trials
Better science through fines
Drugmakers and researchers didn’t submit results for nearly one in three studies where they were “highly likely” to be required to do so, Ed Silverman reports.
It’s an old problem, one that Congress tried to fix nearly 20 years ago with a law requiring clinical trial sponsors to register applicable studies and report their results on the government database ClinicalTrials.gov.
But compliance has been lacking, and FDA enforcement uneven. Now, FDA Commissioner Marty Makary is reminding researchers they could face fines. Some are skeptical that a crackdown is afoot. Read more for why.
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