| |   | Hey, D.C. Diagnosis readers. I hope you all had a nice Memorial Day. For the FDA’s sanity, I hope you thoroughly washed your salad before serving it at this weekend’s BBQ. After this week’s back-to-back tongue lashing from Congress on the infant formula shortage, the last thing the agency needs is another food-borne illness outbreak. I’m at nicholas.florko@statnews.com. | | | The AMA supports training on addiction treatment … until you mandate it Medical groups ranging from American College of Clinical Pharmacy to the American Society of Addiction Medicine are throwing support behind the MATE Act, a bill that would require doctors who prescribe controlled substances to take an eight-hour course on treating opioid use disorder. But there’s a $450 million lobbying behemoth opposing the bill. I’m speaking, of course, about the American Medical Association. The AMA is claiming the bill “will not have a meaningful impact on reducing drug-related overdose,” according to a letter to lawmakers obtained by STAT. AMA’s opposition is surprising not just because the organization is an outlier among doctors’ groups, but because the group has repeatedly emphasized the value of training physicians on treating opioid use disorder. For more on what’s behind AMA’s opposition, check out my story here. | The Senate tries to avoid another Aduhelm The sweeping FDA funding bill unveiled by senators Friday would direct the FDA to stand up an “intra-agency coordinating council” to oversee its use of the controversial accelerated approval pathway, my colleague Lev Facher writes. The policy seems a clear response to the controversy over the FDA’s approval of Aduhelm — and it’s the latest sign that lawmakers are within striking distance of reforming the controversial pathway, which allows the FDA to greenlight drugs without clear evidence they extend patients’ lives. Accelerated approval not your bailiwick? There’s plenty more in the 433-page bill too, including a proposal from Sen. Elizabeth Warren that would force the FDA to finally release regulations meant to lower the cost of hearing aids. Conspicuously missing from the legislation? Any of the House’s proposals on clinical trial diversity. For more on the package, check out Lev’s story here. | A real ‘womp, womp’ moment for Xavier Becerra HHS announced late Friday that it would not walk back a massive spike in Medicare premiums caused by Aduhelm – despite the fact that Biogen slashed the price for the drug last December AND Medicare severely restricted its coverage of the drug, my colleague Rachel Cohrs reports. It’s an embarrassing moment for Becerra, who publicly ordered Medicare officials to consider lowering premiums after complaints from lawmakers about the unnecessary premium hikes. “Legal and operational” hurdles prevented Medicare from lowering premiums, according to a new HHS memo.
You’d think Becerra would have told reporters this in March, when the potential premium drop came up but he made no mention of these potential issues. More from Rachel here. | A passion for peptides The FDA has been flooded with more than 2,000 comments on what might just be the wonkiest topic I’ve encountered in my time covering the FDA: Whether compounders should be allowed to use bulk chemicals to make the peptide glutathione. Why on earth would this prompt such an onslaught of attention? It turns out that backers of natural remedies are passionate – very passionate – about the product, and use it as a treatment for everything from Parkinson’s to insulin resistance. The campaign, it seems, is being orchestrated by the American Association of Naturopathic Physicians. If you’re so inclined, you can check out the comments here. | Drug pricing is very, very complicated Loyal D.C. Diagnosis readers will remember that we were very excited last week about some new data uncovered by the group 46Brooklyn. In the interest of full transparency: We are significantly less excited about the data after chatting with some other drug pricing experts about its limitations. As we stated last week, Texas wasn’t actually publishing 340B prices — which are confidential — but rather an estimation of those prices. The long and short of it is that Texas’ method for calculating these prices is much sloppier than we would have hoped. How sloppy are we talking? Take Humira, for example, which experts have reasonably assumed costs 340B providers just a penny (an explanation of that here). Under Texas’ system, it appears that the state is reimbursing these providers $1,378 for a single dose of the drug. It’s worth mentioning, however, that Texas providers are likely being under-reimbursed for certain drugs, too, and these reimbursement rates only apply to a very small subset of the state’s 340B hospitals and clinics.
In a statement, 46Brooklyn emphasized that the data can be useful for researchers, even if it's nowhere close to perfect. "Imperfect datasets like the Texas Medicaid 340B pricing files help us better directionally understand the incentive dynamics and market distortions within the historically opaque 340B program," the group wrote. "And when more drug pricing data is made publicly available, we will be waiting with our electronic catcher’s mitt." So, to sum up: If you’re a massive drug pricing wonk, I wouldn’t use Texas’ data to estimate actual 340B prices. But if you’re interested in seeing just how much of a headache the 340B pricing system can be … you’ll find lots of fun examples in this dataset. | Sign up for our free pop-up newsletter: ADA in 30 seconds Get insightful analysis of the data presented at the conference of the American Diabetes Association with this newsletter. STAT will be on top of all the news out of the event and will recap the most important advances in research and care for you from June 4-6. Sign up now. | Mounting pressure for Amylyx’s ALS drug ALS patient advocates have organized a serious campaign to convince the FDA to approve an experimental ALS drug from Amylyx Pharmaceuticals, and now, top ALS doctors are getting in on the fight. “We can ethically prescribe this treatment, and should be allowed to offer this option to our patients,” ALS specialists from Columbia University, Harvard, USC, and other major medical schools wrote. It’s still unclear, of course, whether the experts will be able to convince the FDA to approve the drug, especially after the FDA’s own expert panel voted that the evidence supporting the drug wasn’t convincing enough to warrant an approval. An FDA decision on the drug is due on June 29. | What we’re reading -
While a law designed to thwart counterfeit medicines lurches into full force, fake pills keep circulating, STAT -
Coronavirus hasn’t developed resistance to Paxlovid. How long can that last?, STAT - As monkeypox panic spreads, doctors in Africa see a double standard, The Washington Post
- The Anti-Vaccine Movement's New Frontier, The New York Times
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As monkeypox spreads, Bavarian Nordic’s CEO is fielding calls for his vaccine, but doesn’t see panic, STAT
| Thanks for reading! More Thursday,  | | | |
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