SENATE ADVANCES OMNIBUS — The Senate on Thursday blasted through a series of amendment votes to send its $1.7 trillion government funding bill to the House in a 68-29 vote. The package, which is expected to be voted on by the House early today and sent to President Biden, proposes adding $226 million in budget authority — approximately a 6.5 percent increase — to the FDA. If signed into law, the FDA would have a fiscal 2023 budget of more than $3.5 billion before user fee revenue is added. Fun fact: Congress is also passing a continuing resolution through Dec. 30. The 4,100-plus page omnibus is so large, it will take a while to enroll and make it to the president’s desk. As such, lawmakers don’t want the government to shut down in the meantime. The omnibus also contains a number of new FDA policies — deemed the Food and Drug Omnibus Reform Act of 2022 — that were left off the FDA User Fee Reauthorization Act of 2022 earlier this year. Accelerated approval: Congress shored up the FDA’s oversight of its accelerated approval pathway, giving the agency clear authority to require post-approval clinical trials confirming a drug’s benefit. It also lets regulators set parameters — such as enrollment goals, milestones and a target completion date — for post-approval studies and institute an expedited process to rescind an accelerated approval. Cosmetics: The bill includes the first overhaul of how cosmetics are regulated in the U.S. since the 1930s, granting the FDA power to order mandatory recalls of lotions and potions it suspects are adulterated or misbranded, and to issue good manufacturing practice regulations, allowing the agency to inspect company records. But the deal doesn’t impose user fees on the industry, making the agency’s newfound authority subject to the annual appropriations process. The bill authorizes $14.2 million for the FDA to begin implementation in fiscal 2023, increasing to nearly $26 million in fiscal 2024 and $42 million in each of fiscal years 2025 through 2027. Our questions: How much work on these new rules will get done next year, and how much more manpower does the FDA need to do so? ARPA-H: The new Advanced Research Projects Agency for Health will be part of the National Institutes of Health, ending a dispute over whether the agency should be independent, Ben Leonard and Megan R. Wilson report. But the bill — which says it cannot be on NIH’s Maryland campus and have offices in at least three geographic areas — does not settle where it will be located. No VALID Act: Legislation that would have overhauled the regulation of diagnostics and laboratory developed tests fell off the omnibus after House Energy and Commerce ranking member Cathy McMorris Rodgers (R-Wash.) led efforts to block the provision. “The loss of a legislative framework means that FDA will have to take a piecemeal approach,” a former FDA official granted anonymity to discuss the decision told POLITICO. “I think FDA comes back with enforcement actions. They're not going to just walk away from the issue. They have serious concerns about some tests out there.” IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. We wish you a safe, happy and calm holiday season. See you in 2023! Send tips, feedback and merriment to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, Katherine talks with Ruth Reader about the state of artificial intelligence in health care and why it hasn’t reached its promise yet.
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