| | | |   | Hello D.C. Diagnosis readers. I’m writing you this intro at 8 p.m. from the Capitol basement, so you know we have some juicy intel to deliver. I’m at nicholas.florko@statnews.com — please send me tips … they’ll make my very tired morning slightly less grumpy. | | | Biden whip team: Call your office Robert Califf was formally nominated to be Biden’s FDA commissioner in November. He’s had countless meetings with senators to answer their concerns. And he’s a well-known commodity in the chamber: He was confirmed to the same role 89-4 in 2016.
But my colleague Rachel Cohrs and I surveyed nearly a dozen Democrats Monday night and nearly all of them told us they were still undecided about how they were going to vote when Califf’s nomination comes to the floor.
It’s the clearest sign yet that Califf’s nomination is in serious trouble, and that the Biden administration has a long-way to go before they can confidently hold a vote on Califf’s nomination.
For the scoop on who is still undecided about Califf’s nomination, check out my story with Rachel here. | Assisted living providers livid about Biden redirecting Covid-19 relief Assisted living facilities are enraged that the Biden administration has continued to divert funding intended to help health care providers recover from Covid-19 to pay for contracts for vaccines and therapeutics, as STAT first reported Wednesday. Assisted living providers have long argued that they’ve been disadvantaged by the formulas the federal health department has used to distribute the $178 billion pot of Covid-19 relief. They say they’ve received less than 1% of the funding, while operating on $30 billion (yes, billion with a “b”) of estimated losses from paying for personal protective equipment, tests, hazard pay, and more during the pandemic. Between the Trump and Biden administrations, nearly 10% of the money has been used to pay drug makers.
“Instead of the Provider Relief Fund being used to protect the most vulnerable from this pandemic, the administration used it as a piggybank for programs Congress never intended to be paid for out of the fund,” said Maggie Elehwany, the vice president of government affairs and policy at Argentum, a trade group for senior living communities.
Reps. Lori Trahan (D-Mass.) and Brian Fitzpatrick (R-Pa.) introduced a bill last week that would establish a new, $10 billion “Caregiver Sustainability Fund” to help close the relief gap for senior living providers. | Patient differences matter in health benefit design How can we design health care benefits that take patients’ individual differences into account? Learn more about what decision-makers can do to provide more equitable care. Download your copy of the National Pharmaceutical Council’s Myth of Average report today. | Buckle up: It’s time to authorize user fees The House Energy & Commerce committee will hold a hearing this Thursday to begin the process of authorizing three of the so-called user fee agreements that make up roughly half of the FDA’s funding each year.
The hearing will be the House’s first chance to question two of the agency’s top officials, Peter Marks and Patrizia Cavazzoni, about everything going on at the FDA. And there’s plenty of controversies to ask about: The officials are likely to face questions on everything from the agency’s controversial approval of the Alzheimer’s drug Aduhelm to its recent decision to allow the distribution of the abortion pill Mifeprex by mail, predicted one former FDA official.
“The [authorization] process this go-around is going to be a painful one for the agency,” the former official said. “Get your popcorn ready; the agency and HHS are going to get a firm reminder that Congress is still in charge.”
Whether this hearing or a follow-ups in the Senate HELP Committee will actually impact the FDA in any way — beyond subjecting them to a tongue lashing — remains to be seen. Lawmakers typically use these agreements, which must be reauthorized every five years, to tack on legislation for their pet legislative projects. Already drug industry sources have speculated that Congress could throw in legislation to rein in FDA’s use of accelerated approval.
But several lobbyists told STAT that E&C staff have made it clear to lawmakers and to lobbyists that they want the legislation to be as “clean” as possible. A spokesperson for Democrats on the committee did not respond to questions about how the committee might achieve that. Instead they said: “FDA user fee reauthorizations are must-pass legislation. The Committee is working in a bipartisan manner to ensure they receive broad support and are signed into law in a timely manner.” | | | Thanks for reading! More next week,  | | | |
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