| | | Happy Thursday, D.C. Diagnosis readers! The D.C. team has got a jam-packed issue for you this morning. Before we jump in, I wanted to take a moment to congratulate Bill Nye on his D.C.-area nuptials, featuring Smithsonian Castle photos by longtime White House photographer Pete Souza. Drop me news tips and/or fun wedding photos at rachel.cohrs@statnews.com. | | The drug pricing bill of pharma’s dreams The long-awaited insulin pricing reform bill from Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) came out yesterday, and drugmakers couldn’t have hoped for anything better, I report in a new story this morning. The policy sets up a complicated (and voluntary!) new way of paying for insulin. It would explicitly allow pharmaceutical companies to maintain their profit margins from 2021 into perpetuity, and even raise prices by the rate of inflation, which has been pretty steep these days. That’s actually an improvement over the status quo for insulin makers, as their net prices have been staying steady or sinking over the past decade. The proposal has created a divide in the patient advocate community, too. Insulin-specific, pharma-funded patient groups have endorsed it, but other independent groups have blasted the proposal and are holding out for bigger, more comprehensive reform. This is worth paying attention to over the next few weeks. Shaheen said they are aiming for a floor vote soon after the July 4 recess, but they will need a final budget estimate first, and Collins said she hasn’t nailed down GOP support. Read more. | Much ado about nothing (yet), tobacco edition You may have seen some headlines, and possibly some push alerts, about a big new FDA initiative to lower the level of tobacco in cigarettes. If that actually happened, it would be a massive deal — but the FDA isn’t close, my D.C. Diagnosis co-author Nick Florko reports. The policy was added to a sort of regulatory to-do list that federal agencies put out twice a year. Like many of our own to-do lists, it’s often the case that many items get left undone. In fact, the same policy was actually added in 2019 during the Trump administration, but the FDA never acted on it. Marc Scheineson, a former FDA official who is now a partner at the law firm at Alston & Bird, and represents tobacco companies, also called the press attention “premature.” “I don’t know if this is a trial balloon [from the White House], or just a slow news day,” he added. Still, the policy is clearly a priority for Commissioner Robert Califf. Read more about what’s next in Nick’s new story here. | The debate over ARPA-H's independence is still going It’s been a big week for President Biden’s science agenda. On Tuesday, he announced the nomination of former DARPA director Arati Prabhakar to replace Eric Lander as his science adviser. And on Wednesday, House lawmakers passed a bill to formally authorize the White House’s new high-stakes research agency, ARPA-H. The moves have rekindled the controversy surrounding the new science office, my colleague Lev Facher reports. Prabhakar, notably, has vocally opposed Biden’s plan to create ARPA-H as a wing of the National Institutes of Health. And the House bill explicitly defies the White House by creating the new agency as an “independent operating division” far from the NIH’s realm. The White House isn’t happy. While it endorsed the bill, it publicly opposed the provisions that make ARPA-H independent. But the bill’s author, Rep. Anna Eshoo, isn’t backing down. As she told Lev: “That’s their prerogative.” Read more here. | First-of-its-kind map reveals opportunity for improvement to the medicine supply chain You can’t strengthen something if you don’t know its weaknesses. From USP, a first-of-its-kind medicine supply map enhances visibility into the upstream medicines supply chain to help identify vulnerabilities and guide investment in supply chain resilience. Insights from the map can help governments, manufacturers, distributors, and providers lower quality risks, reduce the frequency and duration of potential drug shortages, and ensure patients have access to the medicines they need when they need them. Learn more. | Medicare may foot the bill for more pricey Alzheimer’s scans After all the hubbub about Medicare’s coverage decision for the new Alzheimer’s drug Aduhelm, the agency is taking a small step forward on a related issue — what to do about the the pricey scans required to see if patients actually have the brain plaques the drug’s supposed to target. Right now, Medicare only covers one scan for a patients’ lifetime in the context of certain studies, but officials are opening up public comment about allowing more scans related to clinical trials for Aduhelm, my eagle-eyed colleague Bob Herman noticed. The Alzheimer’s Association thinks the move is a “step in the right direction,” said Chief Science Officer Maria Carrillo. She said allowing payment for more scans could help physicians diagnose Alzheimer’s sooner, know if drugs are working, and know eventually when to stop taking medications. | What we're reading -
To protect people with addiction from discrimination, the Justice Dept. turns to a long-overlooked tool: the ADA, STAT -
FDA to order Juul e-cigarettes off U.S. market, Wall Street Journal -
Supreme Court rules in favor of insurance plan that pushed kidney failure patient to Medicare, STAT -
Driving 80 miles for cancer care, Michigan family carries heavy cost of high gas prices, MLive - Senate lawmakers introduce a bill to help the FDA and the U.S. Patent Office coordinate, STAT
| Thanks for reading! More next week, | | |
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