A debt-ceiling win for pharma

Presented by Express Scripts by Evernorth: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

May 31, 2023 View in browser   By Katherine Ellen Foley and David Lim Presented by With Annie Snider Driving the day The pharma industry likes what it sees in the debt ceiling bill, a draft of which is pictured above. | Jon Elswick/AP Photo DRUGMAKERS CAUTIOUSLY OPTIMISTIC ABOUT DEAL — The pharmaceutical industry expressed relief Tuesday over the debt ceiling deal struck by the White House and House Speaker Kevin McCarthy. A big part of their relief is the deal retaining $5 billion for the funding of research into improved Covid-19 vaccines and treatments. Covid vaccine maker Novavax said it “remains encouraged by the continued investment in and recognition of the need for continued development of Covid vaccines.” The debt limit package, if signed into law, would claw back about $30 billion in federal funding appropriated during the pandemic. It doesn’t touch the Inflation Reduction Act’s drug price negotiation provisions despite the Biden administration's push to expand them in its fiscal 2024 budget proposal. “Given the impacts on capital markets and capital formation, we have been watching closely — cautiously, optimistically — as negotiations have progressed,” Nick Shipley, Biotechnology Innovation Organization’s chief advocacy officer, said. A list specifying the clawed-back Covid relief funds was obtained by POLITICO from a White House source granted anonymity to share some of the details of the debt ceiling package. The list, which the administration is sharing with lawmakers, outlines the exclusions from the clawbacks. They include more than $800 million to monitor and strengthen pharmaceutical supply chains and roughly $2 billion for CDC activities such as genomic surveillance of the virus. But public health experts await more details. Georges Benjamin, executive director of the American Public Health Association, praised the agreement for maintaining funding for vaccines and treatments for people without health insurance and veterans, and ongoing research for better vaccines and treatments. But if a Covid surge hits the U.S. in the future, another emergency appropriation might be necessary, he added. “It is a problem, but probably low-risk for now,” Benjamin said. The Association of State and Territorial Health Officials and other public health groups are still trying to understand the impact of the Covid-funding clawbacks on the CDC and state public health efforts to strengthen public health infrastructure. “It looks like a lot of [the infrastructure] is still in place, but we are not certain of that,” ASTHO chief medical officer Marcus Plescia said. IT'S WEDNESDAY. WELCOME TO PRESCRIPTION PULSE. Our warmest welcome to the National Zoo and Conservation Biology Institute’s newest baby gorilla, who was born over the holiday weekend. Send news, tips and summer weather to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard chats with POLITICO's Victoria Guida about her data analysis revealing how low-income workers saw significant wage gains during the pandemic as a result of market changes and several government policies. Plus: What the data shows about health care workers. Listen to today’s Pulse Check podcast   A message from Express Scripts by Evernorth: 60 million Americans live in rural areas. Yet less than 10 percent of physicians practice in those parts of the country. That’s half the number of physicians needed to provide essential care to those communities. Express Scripts by Evernorth is expanding health care access for rural communities by advocating for more pharmacy services and reimbursement opportunities. Making health care more accessible for all. Learn more.   Industry Intel The FDA is expected to approve Pfizer's RSV vaccine for older adults today. | Andrew Burton/Getty Images DECISION DAY FOR SECOND RSV VACCINE — The FDA will likely approve Wednesday a respiratory syncytial virus vaccine for older adults from Pfizer. It’s not a certainty, but if approved, the vaccine would be the second RSV shot available to adults over 60, who are susceptible to severe disease caused by the virus. The FDA approved the first RSV vaccine for older adults from GSK earlier this month. An endorsement with caveats: The agency’s independent advisory committee gave a lukewarm recommendation in February that the FDA approve Pfizer’s RSV vaccine. The panel voted 7-4 with one abstention that the data the company provided showed the vaccine candidate was effective and 7-4 with one abstention that it was safe. A late-stage clinical trial showed the candidate was more than 85 percent effective at preventing moderate cases of RSV, though it followed participants for just one season. Pfizer is studying the vaccine’s durability through multiple RSV seasons, and no data is yet available. Three study participants out of 17,215 who received the shot in the completed trial developed severe autoimmune reactions affecting their nervous system, sparking concerns about its safety. However, the agency’s advisers narrowly voted in favor of the potential benefit of an RSV vaccine outweighing its potential risks. POSITIVE RESULTS FOR A BLOOD DISORDER TREATMENT — Pfizer said on Tuesday that Phase III trial results of its weekly subcutaneous injection intended to treat hemophilia significantly reduced the number of bleeding episodes patients experienced compared to existing treatment. Currently, people living with hemophilia, which puts them at risk for severe bleeding, must receive frequent and medically supervised infusions. The company said it plans to present data from the trial at upcoming conferences and will file an application for FDA approval in the coming months. POLITICO’s Health Care Summit on Wednesday, June 7, will explore how tech and innovation are transforming health care and the challenges ahead for access and delivery in the U.S. Register now. MEDICAL DEVICES NEW ETHYLENE OXIDE DEADLINE — Under the terms of a settlement agreement detailed in the Federal Register on Tuesday with environmental groups, EPA said it will finalize by March 1 stringent new rules governing emissions of the potential carcinogenic gas from medical sterilization facilities. That puts in place a hard deadline for finalizing a hot-button rule proposed this spring that has raised concerns by federal health regulators and the medical device industry about potential disruptions to the supply chain for everything from catheters to artificial heart valves, Annie reports. The EPA had targeted October for finalizing the rule. The settlement agreement will be open for public comment on June 30 and then must be approved by a federal judge.   GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE.     Pharma Worldwide NO CONSENSUS ON HEALTH AGREEMENT YET — Participating countries at the World Health Assembly in Geneva failed to adopt the Health for Peace Initiative on Tuesday, POLITICO’s Ashleigh Furlong reports. The initiative seeks to ensure that global health emergency responses don’t trigger conflicts, but of the 194 nations, some, including Brazil, India and South Africa, said they had concerns the initiative encroaches on state sovereignty. They opted to potentially revisit the proposal at the 2024 World Health Assembly meeting.   A message from Express Scripts by Evernorth:   Document Drawer The FDA proposed a rule on Tuesday that would create a prescription drug guide for consumers called “Patient Medication Information.” The one-page, standardized documents would provide patients with clear, accessible information intended to help them take their drug products properly. The FDA published final guidance on Friday on how drug companies should adjust for the differences in characteristics, such as race, ethnicity or socioeconomic status, of participants in their analyses of randomized clinical trials. The White House Office of Management and Budget is reviewing a proposed rule from CMS that will float potential options for cutting reimbursement rates for 340B hospitals. The proposal is a response to the Supreme Court's June 2022 ruling against HHS in American Hospital Association v. Becerra, which held cuts instituted in 2018 were unlawful.   DON’T MISS POLITICO’S HEALTH CARE SUMMIT: The Covid-19 pandemic helped spur innovation in health care, from the wide adoption of telemedicine, health apps and online pharmacies to mRNA vaccines. But what will the next health care innovations look like? Join POLITICO on Wednesday June 7 for our Health Care Summit to explore how tech and innovation are transforming care and the challenges ahead for access and delivery in the United States. REGISTER NOW.     Quick Hits Alabama’s abortion ban, one of the most restrictive in the nation, is threatening the financial operations of the state’s clinics that provide comprehensive women’s health services, Alice Miranda Ollstein reports for POLITICO magazine. For STAT+, Lizzy Lawrence reports on how Stimwave gave thousands of patients a fraudulent device to treat their chronic pain. Elizabeth Holmes, founder of the once high-flying but now defunct Theranos blood diagnostics firm, reported to a Texas federal minimum-security women’s prison Tuesday to begin her sentence of 11 years and three months for defrauding the company’s investors, Erin Griffith reports for The New York Times.   A message from Express Scripts by Evernorth: Express Scripts by Evernorth believes America’s rural communities, and independent pharmacies, deserve better. That’s why we’re leading the way with new ways to close gaps in care through partnerships with independent pharmacies across the U.S. We’re establishing the industry’s first Independent Pharmacy Advisory Committee to help pharmacies everywhere better support underserved communities. We’re making it easier to offer much-needed services like vaccinations, lifestyle counseling, and behavioral health screenings. And we’re increasing reimbursements paid to rural pharmacies for the essential services they provide today and well into the future. We invite all our partners and our competitors to follow our lead. And help improve the quality of care for all. Learn more.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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