| | | | |  | | By Daniel Payne | | | With Katherine Ellen Foley, Alice Miranda Ollstein and Megan R. Wilson
| | |  Drugmaker Danco, which sells the abortion pill mifepristone under the brand name Mifeprex, faced a hostile reception from a highly conservative three-judge panel of the 5th Circuit Court of Appeals on Wednesday. | Anna Moneymaker/Getty Images | POISED TO LIMIT ABORTION PILL ACCESS — Three Republican-appointed judges at the 5th Circuit Court of Appeals in New Orleans grilled attorneys for the Justice Department and drug manufacturer Danco on Wednesday over the FDA’s approval of the abortion medication mifepristone more than two decades ago, Alice reports. The panel is expected to rule in the coming months, but the U.S. Supreme Court will have the final say. The high court ruled in April that the status quo on the drugs must continue while the issue is litigated, meaning any rollback of access to the pills can’t occur if the case is appealed back to them, likely next year. Wednesday’s arguments centered on the anti-abortion plaintiffs’ standing to sue: whether they missed their window to challenge the decades-old federal approval of the pills or can only challenge more recent agency rules aimed at broadening access to the drugs. The hearing also featured several surreal moments in which judges accused the FDA of characterizing pregnancy as an illness, demanded attorneys walk back criticism of a lower court judge, and wondered aloud about the safety of obtaining the pills via telemedicine — or as one judge called it, the “mail business thing on the computer.” WELCOME TO THURSDAY PULSE. What big health decisions — from abortion access to Medicare reimbursement rates — are in the works? Let me know at dpayne@politico.com. TODAY ON OUR PULSE CHECK PODCAST, host Megan Messerly interviews Daniel Payne about the push by Senate HELP Committee Chair Bernie Sanders to pour nearly $200 billion of new money into the health care system in an effort to address growing health workforce shortages and financial woes of community health centers.
| | | | | | | A message from PhRMA: Middlemen like PBMs are charging fees tied to the price of medicines, which means they make more money when the price of a medicine goes up. This business model allows PBM profits to soar and can lead to higher costs for patients. It’s time to lower costs for patients by holding middlemen accountable. | | | | | | | 
| MORE THAN 100,000, AGAIN — The CDC released provisional data Wednesday that found 109,680 people in the U.S. died from drug overdoses in 2022. That’s a slight increase over the 2021 figure: 109,179. Though the increase between 2021 and 2022 is much smaller than the jump in recent years, the upward trajectory since 2015 has been dizzying. The new data highlights a huge — and growing — problem in the U.S. that lawmakers and administration leaders in Washington and across the states are scrambling to fix. The pressure is also on in the states. On Wednesday, 11 Democratic governors sent a letter to the Biden administration requesting faster implementation of a law aimed at expanding non-opioid pain treatments and substance use data, according to a copy shared first with Pulse. That bipartisan law, the Non-Opioids Prevent Addiction in the Nation Act, was signed late last year, with a requirement to be implemented by 2025. But the governors want faster action, citing an opioid epidemic that isn’t letting up. “Expanding access to non-opioids is critical to tackling the opioid crisis,” New Mexico Gov. Michelle Lujan Grisham, who led the effort, said in a statement. “The federal government must act quickly to help prevent opioid addiction and save American lives.” The group is asking HHS to implement the law a year early, by the beginning of 2024. New federal legislation is in the pipeline as well — as are proposed solutions on multiple fronts: leaning on Mexico’s government for more action against cartels, boosting government payments to providers treating addiction, treating fentanyl like a chemical weapon and funding studies to understand overdose prevention strategies. Those actions have become increasingly urgent with the discovery that xylazine, a horse sedative also known as Tranq, in fentanyl overdose deaths, possibly adding a new threat within the opioid epidemic.
| | | | 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. | | | | | | | | FIRST IN PULSE: CMS AND THE DOC CAUCUS COME TOGETHER — Meena Seshamani, CMS deputy administrator and director of the Center for Medicare, is set to speak to the GOP Doctors Caucus this morning, a spokesperson told Pulse. They’ll discuss “major Medicare initiatives” like prior authorization, telehealth and rural health. Those issues remain hot in Congress, where they’ve been the subject of hearings this week, and represent some open communication between GOP lawmakers and the Biden administration. INDUSTRY BACKLASH TO E&C BILLS — Hospital and pharmacy benefit manager industry groups are pushing back against bipartisan bills advanced yesterday, Megan reports. Those bills, advanced during a markup in the House Energy and Commerce Health Subcommittee, aimed to increase transparency and competition in the health market. The groups say the efforts to provide more transparency and competition would have unintended consequences. Hospitals have waged a battle over changes to site-neutral payment policies, which would ensure that Medicare pays the same amount for a service regardless of where it occurs. Yesterday, the panel advanced changes to site-neutral payments involving medicines, which lawmakers said they’d use to offset certain Medicaid cuts for some hospitals. “This is simply not the time to cut payments to hospitals, many of which are still under severe financial pressure coming out of the pandemic,” said Stacey Hughes, an executive vice president of the American Hospital Association. Although the committee did not take up broader site-neutral reforms it had been considering, Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) vowed to return to the issue. PBMs — the middlemen that manage prescription drugs for insurers — pushed back on the bills, too. They abide by disclosure rules, and companies frequently provide their customers — often employers and health plans — with additional information about how they operate, said Greg Lopes, a spokesperson for the Pharmaceutical Care Management Association, which represents PBMs. In particular, the PCMA opposes proposals requiring PBMs to disclose details about the discounts they negotiate with drugmakers, saying it would give “drug companies an invitation to collude on price.” While we’re on the subject, the Federal Trade Commission said Wednesday it’s expanding its inquiry into pharmacy benefit managers requesting records and information from two companies that negotiate drug discounts on PBMs’ behalf, Megan reports. The compulsory orders were sent to Zinc Health Services, formed by CVS Caremark in 2020, and Ascent Health Services, a group-purchasing organization formed by Express Scripts in 2019. Those orders come almost a year after the antitrust regulator began looking into the industry’s business practices.
| | ACROSS THE ATLANTIC — The U.S. and EU are collaborating on cancer cures and global health more broadly, POLITICO’s Carmen Paun reports. The task force, launched Wednesday, will connect the U.S. cancer moonshot and the National Cancer Plan and two EU initiatives, the Beating Cancer Plan and the Cancer Mission, to share best practices and develop new therapies. The U.S. and the EU underscored commitments to negotiating an international pandemic agreement at the World Health Organization and establishing mechanisms to facilitate access to tests, treatments and vaccines during health emergencies.
| | | | A message from PhRMA:   | | | | | CONSIDERING RSV VACCINE FOR NEWBORNS — The FDA’s independent experts will consider Pfizer’s bid for a respiratory syncytial virus vaccine candidate for newborns today, Katherine reports. The candidate, administered to pregnant mothers in their second or third trimester, was more than 80 percent effective at preventing severe RSV in newborns up to 3 months old. In late-stage clinical trials, the vaccine was about 70 percent effective at preventing severe disease in babies up to 6 months old. Pfizer’s RSV vaccine would be the first for newborns, but the agency is also considering an application from Sanofi and AstraZeneca for a monoclonal antibody that could be given to newborns for added protection during their first RSV season, which typically runs during fall and winter. The agency’s advisers will discuss the antibody on June 8, and the FDA will make a final decision by the end of September. Pfizer also asked the FDA to approve its RSV vaccine candidate for adults 60 and older. The agency’s independent advisers recommended the agency approve the shot, and the FDA will decide by the end of the month. The FDA approved the first RSV vaccine for older adults made by GSK earlier this month. What’s next: The FDA is slated to decide on Pfizer’s RSV vaccine for newborns in August.
| | | | 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. | | | | | |  | what we're reading | | The New York Times reports on drug shortages leading to nationwide rationing. The Wall Street Journal reports on the years of progress being reversed in the death rates of American kids. GBH in Boston reports on an issue cropping up around the country: the fallout of hospitals dropping universal masking.
| | | | A message from PhRMA: PBMs control your health care. Pharmacy benefit managers (PBMs) decide if medicines get covered and what you pay, regardless of what your doctor prescribes. They say they want lower prices, yet they often deny or limit coverage of lower-cost generics and biosimilars, instead covering medicines with higher prices so they make more money. This business model allows PBM profits to soar and can lead to higher costs for everyone. What else are they hiding? | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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