HAPPY BUDGET DAY — Washington, D.C.’s annual tradition has come and gone — and the topline for the FDA in the proposed fiscal 2024 budget is that President Joe Biden wants to boost the agency’s funding to $7.2 billion, an increase of $521 million over fiscal 2023 levels. The FDA’s funding comes primarily from two buckets: taxpayer funds appropriated by Congress and user fees collected from industry. The proposed HHS budget-in-brief calls for an additional $372 million in the agency’s discretionary funding, bringing the first bucket to nearly $4 billion. The user fee bucket would increase by $150 million, bringing the proposed level to nearly $3.3 billion. Reality check: The budget request is typically considered dead on arrival in a divided Congress. Drug pricing: The administration’s proposal floats a slate of prescription drug measures it estimates will save more than $200 billion over 10 years by expanding the scope of the Inflation Reduction Act’s Medicare negotiation provisions and more. Biden wants to empower CMS to negotiate 20 Part D drugs in 2026 and 40 Part B and Part D drugs each subsequent year. Under current law, Medicare can negotiate the price of 10 Part D drugs in 2026, another 15 Part D drugs in 2027, 15 Part B and Part D drugs for 2018 and an additional 20 Part B and Part D drugs in 2029 and beyond. The pharmaceutical industry, which has vehemently opposed allowing Medicare to negotiate drug prices, has been pushing to align the number of years biologics and small-molecule drugs are excluded from negotiations. The proposal would do that, but the policy changes will likely not please drugmakers. If adopted, drugs and biologics would be excluded from negotiation for five years, a decrease from the IRA’s effective nine years for small-molecule drugs and 13 years for biological products. “The White House hasn’t even implemented the pharmaceutical provisions in the Inflation Reduction Act, yet they are already proposing to further destabilize Medicare, slow critical investment in future research and development, stall drug innovation, and ultimately harm patients,” said Biotechnology Innovation Organization chief advocacy officer Nick Shipley. “Press reports indicate HHS wants to double the size of the price control program, without even the slightest acknowledgment about impacts on diseases like oncology or Alzheimer’s.” Biden’s budget also proposes giving Medicaid and the Children’s Health Insurance Program the ability to negotiate supplemental drug rebates on behalf of states. It also proposes to extend Medicare inflation-pegged drug rebates and a $35 monthly cap on insulin cost-sharing in the commercial market. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Hold the flowers: The Washington Post’s Capital Weather Gang revised its estimate this week on D.C. cherry blossoms’ peak bloom, saying it could arrive as soon as March 18 instead of March 25–29. Plan your trips to the Tidal Basin (and the lesser-traveled National Arboretum) accordingly. Send news, tips and your best blossom shots to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Carmen Paun talks with Ben Leonard about the debate over the use of quality-adjusted life years, or QALYs, which is a tool designed to help measure the cost effectiveness of drugs and other medical treatments. Detractors say the statistic discriminates against people with disabilities by undervaluing how much treatments help them.
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