A pharma-reviled Medicare budget proposal

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Mar 10, 2023 View in browser   By David Lim and Katherine Ellen Foley Driving the Day President Joe Biden is asking for a funding boost for the FDA in his proposed fiscal 2024 budget. | Sarah Silbiger/Getty Images 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. Listen to today’s Pulse Check podcast   DOWNLOAD THE POLITICO MOBILE APP: Stay up to speed with the newly updated POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need, reimagined. DOWNLOAD FOR iOS– DOWNLOAD FOR ANDROID.     Capitol Hill in Washington, D.C. | Mark Wilson/Getty Images NOT SO FAST — Senate Finance Committee Republicans are urging the Biden administration to abandon the development and deployment of a Center for Medicare and Medicaid Innovation accelerated approval payment model that aims to incentivize timely confirmatory clinical trials. SANDERS WANTS INSULIN PRICE CAP — Fresh off Eli Lilly’s pledge last week to lower list prices for certain insulin products, Senate HELP Committee Chair Bernie Sanders (I-Vt.) is proposing the Insulin for All Act of 2023 which would limit manufacturers’ prices for insulin contained in vials, pens, cartridges or other forms of delivery to “$20 per 1,000 units.” PEW PRESSES FOR PASTEUR — A group of 230 organizations, including the Pew Charitable Trusts, are asking Sanders and Senate HELP Committee ranking member Bill Cassidy (R-La.) to attach legislation to incentivize the development of new antimicrobial drugs to the Pandemic and All-Hazards Preparedness Act later this year. The groups argue the legislation, the Pioneering Antimicrobial Subscriptions to end Upsurging Resistance Act, which got a shoutout in Biden’s budget proposal, is critical to being prepared for bacteria resistant to existing drugs. Eye on the FDA TOBACCO MANUFACTURING STANDARDS PROPOSED — On Wednesday, the FDA took a step toward harmonizing the design, making, packing and storing of tobacco products by proposing a rule that would set manufacturing standards. The standards aim to minimize potentially dangerous contaminants and ensure consistent levels of nicotine and other components in tobacco products, including vapes. “FDA has had a longstanding commitment to the development of [this] rulemaking. This rule is foundational and is informed by FDA’s experience with biennial inspections of tobacco products since 2011,” said FDA spokesperson Abigail Capobianco. Eyes emoji: The agency also said it would convene a May 18 meeting of its tobacco advisory panel to discuss the standards. The agency hasn’t called its tobacco advisers since 2020. What’s next: The FDA will hold a public hearing on April 12 to listen to comments and take written public comments for the next 180 days. FDA ADDRESSES ALBUTEROL SHORTAGE — In a tweet thread on Thursday, the FDA said it was tackling the shortage of albuterol in certain forms and noted the shortage does not affect personal albuterol inhalers. MAMMOGRAM STANDARDS FINALIZED — Mammography facilities will be required to give patients information about their breast density under a final rule the FDA published Thursday. The regulation establishes federal baseline standards intended to ensure the quality of mammography services, which include requirements for staff qualifications, report content and equipment standards.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.     Industry Intel PRETERM PREGNANCY DRUG TO BE PULLED FROM MARKET — Drugmaker Covis Pharma said Tuesday it would voluntarily remove its preterm birth drug Makena from the market, Katherine reports. The move comes after an FDA official and an expert advisory panel recommended withdrawing the drug’s approval last year because recent data did not indicate the drug benefits patients or their babies. Makena’s lingering presence in the market highlighted an ongoing discourse around the FDA’s accelerated approval pathway, which allows drugs for serious conditions with unmet needs onto the market before their benefit to patients is confirmed through additional studies. FDA officials said last year that if the agency can’t pull drugs without confirmed benefits from the market, the entire accelerated approval pathway would lose credibility. PFIZER READY TO OFFER RSV VACCINES — Kena Swanson, Pfizer’s vice president for viral vaccines, said Thursday that the company is prepared for a fall rollout of its respiratory syncytial virus vaccine, POLITICO’s Sarah-Taïssir Bencharif reports. The company is awaiting regulatory clearance for its vaccines geared at immunizing infants and older adults. Coronavirus FULL APPROVAL GIVEN TO COVID TEST — On Wednesday, Quidel’s Sofia 2 test became the first point-of-care rapid antigen Covid-19 test to receive the FDA’s so-called De Novo marketing authorization — traditional approval instead of an emergency use authorization. ODD LUCIRA DETAILS FROM FDA — The FDA’s top medical device regulator, Jeff Shuren, released a rare statement on Tuesday explaining why the agency’s emergency use authorization for Lucira Health’s over-the-counter Covid/flu test took as long as it did. He said the company’s initial application was inadequate because the agency “determined the test posed a risk to consumers due to a toxic substance identified in one of the test components.” The FDA official said Lucira submitted a revised application at the end of 2022, which led to the emergency use authorization for the test the same week the company filed for Chapter 11 bankruptcy and announced it would try to sell its business. It said it plans to continue normal operations while pursuing a sale. Pharma Worldwide DENMARK SLAMS PHARMA ACCESS PROPOSAL — POLITICO’s Carlo Martuscelli obtained documents showing that Denmark attacked a European Commission proposal to encourage pharmaceutical companies to launch in all 27 of the European Union’s member countries. Quick Hits For STAT, Rachel Cohrs notes that Pfizer’s Albert Bourla donated $2,900 — the maximum personal contribution possible — to Mehmet Oz’s unsuccessful Senate campaign in Pennsylvania.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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