| | | |   | Happy Tuesday, D.C. Diagnosis readers, and welcome back from the long weekend! I’m thrilled to be back with you all digitally in your inbox, but if you’re interested in hanging out with the STAT D.C. team in person (and, of course, taking in some incredible panels related to rare disease research), come join us at our event next week on Thursday, Sept. 15. As always, send news tips to rachel.cohrs@statnews.com, and drop me a note if you’re coming by the event and want to say hi! | | | Is the U.S. throwing away its shot(s)? The federal government has authorized new, updated Covid-19 shots that will be used to boost Americans this fall. But what happens to the millions of legacy Covid-19 vaccines already in circulation? Senior Biden officials are in discussions about what to do, my colleague Sarah Owermohle reports. There are more than 20 million Moderna doses and roughly 30 million Pfizer and BioNTech doses currently in the national stockpile, according to one senior administration official. That does not include millions already dispatched to pharmacies around the nation. There is still a need for some of them, as the FDA still recommends the original composition of Moderna and Pfizer and BioNTech’s vaccines for a person’s first two doses. But concerns about the doses expiring before they can be used have U.S. officials mulling more international donations. They’re worried, too, about depleting the existing stockpile, which for now is expected to last at least through mid-December. The situation is quite the dilemma, and will be a sticky one for the White House to navigate in the coming months. | Pfizer isn’t sharing Covid-19 vaccine for next-generation research While the White House is begging Congress for more funds for research into next-generation Covid products, some prominent university researchers are complaining that they can’t get mRNA vaccines to use in their research on next-generation vaccines. Researchers would likely need drug makers’ permission to conduct studies involving the vaccines, and Pfizer said the company isn’t considering any outside studies right now. Moderna didn’t respond to an inquiry about their policy. The companies’ stances are legal and in line with the companies’ commercial interests, said Ana Santos Rutschman, a professor of law at Villanova University. But some university researchers argue the posture slows global progress toward more effective vaccines in the future, especially since the United States has already wasted tens of millions of doses of the Covid-19 vaccines. Get the full details on the challenges in my new story out this morning. | The congressional drama isn’t over yet The Senate is back in session this week, and even though Congress has passed quite a bit of health care legislation this year, there’s still more drama to come. Here are a couple important deadlines to mark on your calendars. -
User fees: Technically, Congress’ deadline to pass its FDA user fee reauthorizations is Sept. 30. Sen. Richard Burr (R-N.C.) is pushing for a clean reauthorization bill to be tacked onto a government funding extension bill that also needs to pass by the end of September. Furloughs wouldn’t start right away if they don’t meet the deadline, however, as FDA Commissioner Rob Califf told FDA staff that carryover funding would last until roughly the first week of November. -
Covid and monkeypox funding: The Biden administration has failed for months to make any progress on securing additional emergency funds for the Covid-19 response, but White House officials are hoping to advance that and new money to fight monkeypox when Congress passes a short-term extension for government funding by Sept. 30. Officials are asking for $22.4 billion for Covid-19, and $3.9 billion to fight monkeypox. - Territories Medicaid funding: Additional Medicaid support for the territories expires on Dec. 13. The federal matching percentage would revert back to 55%, from the higher current levels of 76% for Puerto Rico and 83% for other territories.
- Medicare physician payments: Lawmakers gave physicians in Medicare blanket bonus payments at the end of 2020, and they were extended at the end of 2021. Those bonuses, which are currently 3%, expire on Dec. 31. Given the Covid-era Medicare pay bumps were already cut by 2% earlier this year, that’s a pretty significant change for medical practices.
| House Biogen investigation faces time crunch  Rep. Carolyn Maloney (JONATHAN ERNST/POOL/AFP via Getty Images) The House Committee on Oversight and Reform is facing a huge transition at the end of the year, after Chair Carolyn Maloney (D-N.Y.) lost her primary election. That means there’s a time crunch for all the panel’s ongoing investigations, including into the FDA’s approval of the controversial Alzheimer’s drug, Aduhelm. If Democrats keep the House, there will be a new committee chair who may have new priorities. It’s unclear whether a new chair would continue to prioritize the Aduhelm investigation, or whether key staff working on it might leave. It’s also possible that House Democrats will lose control of the chamber in November and therefore the chairmanship entirely, making it even more likely that the committee’s priorities would dramatically shift. The majority gets to pick how subcommittees are set up, so the entire Select Subcommittee on the Coronavirus Crisis could also be disbanded. Both scenarios create an incentive for staff to rush out reports before they lose control. “It is not unusual for congressional committees to wrap up ongoing investigations before the end of a Congress. Committees will often release several reports as part of a final push to showcase their accomplishments,” said Susanne Sachsman Grooms, a partner at Kaplan Hecker & Fink, who spent a decade on staff with the House Committee on Oversight and Reform. However, the investigation is a joint one with the House Energy & Commerce Committee, which could provide more continuity.
A committee spokeswoman did not comment on plans for the Aduhelm investigation specifically, and said the panel will “work diligently to carry out our investigative priorities.” Another probe into the Aduhelm approval process by the HHS Office of the Inspector General is also ongoing. | America's seniors deserve better: modernize Medicare coverage of innovative medical technologies America’s most vulnerable seniors are often forced to wait years for the Centers for Medicare & Medicaid Services (CMS) to cover and pay for innovative medical technology. Thankfully, CMS can significantly accelerate access to transformative medical technologies developed by America’s innovators by including a dedicated coverage pathway in the agency’s upcoming Transitional Coverage for Emerging Technologies (TCET) rule. Learn more about how Congress and CMS are working to accelerate coverage of innovative medical devices. | FDA stands by while vaping companies flout rules Despite much hand-wringing in Washington about which vaping products should be allowed on the market, vape companies are regularly ignoring the FDA’s rules and selling banned liquids and holders anyway, my colleagues Nick Florko and Elissa Welle reported earlier this month. STAT reviewed 120 letters issued to vaping companies between August 2021 and May 2022, covering bans on some 274 named products. According to company websites and information provided by vape shops by phone, at least 139 of the products are still being sold — more than 50% of the products named in those warnings.
This is an important story that raises questions about the FDA’s credibility as an enforcer in this space, and it’s one you won’t want to miss. | The Biden administration may have yet another health care industry lawsuit on the horizon Insurers are all bent out of shape over a new Medicare Advantage rule, my colleague Bob Herman reports, and even threatened a lawsuit in some pretty eyebrow-raising new comments. A rule that would significantly boost audits of MA plans — which often give the government a chance to claw back cash from health insurers — has been stuck in limbo for years due to the industry’s fierce opposition. But CMS has to make a decision by this November: It will either have to finalize the rule, or kill it and start from scratch.
The “rulemaking is unfair, inappropriate, and legally impermissible,” AHIP wrote in its comments, adding the rule also “violates the requirements” of laws that govern administrative procedures. Bob combed through the more than 4,000 comments on the MA program so you don’t have to — read his take here. | What we're reading -
Rahul Gupta, first physician to serve as drug czar, says stigma among doctors is key culprit in addiction crisis, STAT -
Eli Lilly CEO Dave Ricks says the Inflation Reduction Act has slashed value of small molecules, Biocentury -
Your questions on the new Covid vaccine boosters answered, STAT - Biden administration weighs saving monkeypox doses for potential smallpox outbreak, Politico
| Thanks for reading! More Thursday,  | | | |
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