The abortion pill rulings’ lasting mark on the FDA

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Apr 11, 2023 View in browser   By Katherine Ellen Foley and David Lim With Caitlin Oprysko  Driving the day Legal experts disagree about whether a Texas court's abortion pill ruling could overturn the FDA’s approval process. | Sarah Silbiger/Getty Images ‘A VERY DANGEROUS PRECEDENT’ — Texas Judge Matthew Kacsmaryk’s ruling to rescind the approval of the abortion drug mifepristone Friday spooked federal officials — and not just for what it could mean for access to the most popular method of terminating a pregnancy in the U.S. While the Biden administration has already appealed to the 5th U.S. Circuit Court of Appeals, many fear it could set the nation down a path of unwinding FDA’s regulatory authority for other vital products, such as insulin, vaccines and Alzheimer’s therapies, your hosts and POLITICO’s Megan Messerly and Alice Miranda Ollstein report. But the decision cites problems with the FDA’s procedures around mifepristone’s approval, such as the agency’s delayed response to petitions from anti-abortion organizations asking the agency to reconsider its accelerated approval more than 20 years ago. And this, Donley warns, could open the door for others to scrutinize aspects of key drug approvals by the nation’s pharmaceutical regulator, said Greer Donley, associate professor at the University of Pittsburgh law school. Jane Henney, the FDA commissioner when mifepristone was approved, said Monday that “this ruling sets a very dangerous precedent for the FDA’s authority in terms of other new medications.” Dueling rulings: The same day as the Texas ruling, U.S. District Court Judge Thomas Rice in the Eastern District of Washington state issued a conflicting order that blocks the FDA from taking mifepristone off the market. On the one hand, this ruling could require the FDA to use its enforcement discretion, meaning it would not take action on manufacturers or distributors continuing to sell mifepristone. But on the other hand, the second ruling might not be enough to convince all potentially liable entities to risk providing access to the drug, said Andrew Pincus, a visiting lecturer at Yale Law School and an experienced Supreme Court and appellate attorney. Even pharma is bracing itself: If the case makes it to the Supreme Court — which could happen based on the contradiction of the two rulings — pharmaceutical companies would likely rally behind the FDA. “If that were to survive through sort of a theoretical SCOTUS challenge, you really have to look at Congress to ensure we get back to having FDA in the driver’s seat here,” John Murphy, chief policy officer and deputy general counsel of healthcare at the trade group Biotechnology Innovation Organization, said. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. One unintended consequence of working from home? A swelling rat population in the District. Send news, tips and pest control tricks 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 talks with Alice Miranda Ollstein, who unpacks the legal turmoil following differing federal court decisions on the abortion pill mifepristone. Listen to today’s Pulse Check podcast Coronavirus The White House is putting billions of dollars behind the development of next-generation Covid vaccines and treatments. | Olga Maltseva/AFP via Getty Images WHITE HOUSE INVESTS IN NEXT-GEN VAX — The Biden administration is launching a public-private partnership to support the development of new Covid-19 vaccines and treatments, a senior administration official unauthorized to speak on the record confirmed to POLITICO Monday. Details of the more than $5 billion successor to Operation Warp Speed — deemed “Project NextGen” — were first reported by The Washington Post’s Dan Diamond. Top administration health officials have advocated for billions in new Covid funding from Congress for more than a year, but the ask was repeatedly rebuffed by lawmakers who question whether previously authorized money had been prudently spent. The initial $5 billion for the project will come from testing and provider relief funds from the American Rescue Plan. “HHS has been able to reclaim ARP Testing resources through multiple contracts that were executed for significantly less money than the initial estimate,” the senior administration official said.   GO INSIDE THE 2023 MILKEN INSTITUTE GLOBAL CONFERENCE: POLITICO is proud to partner with the Milken Institute to produce a special edition "Global Insider" newsletter featuring exclusive coverage, insider nuggets and unparalleled insights from the 2023 Global Conference, which will convene leaders in health, finance, politics, philanthropy and entertainment from April 30-May 3. This year’s theme, Advancing a Thriving World, will challenge and inspire attendees to lean into building an optimistic coalition capable of tackling the issues and inequities we collectively face. Don’t miss a thing — subscribe today for a front row seat.     Eye on the FDA AGENCIES TO MEET ON ADDICTION TREATMENT — The FDA said Monday it is partnering with the Substance Abuse and Mental Health Services Administration and the Reagan-Udall Foundation, an independent nonprofit tasked with advancing the FDA’s mission, to hold a two-day public meeting on the use of buprenorphine to treat opioid use disorder. The virtual gathering, to be held May 10–11, will focus on supporting the development of new products to treat opioid use disorder and best practices to start and maintain buprenorphine care. Challenges to getting buprenorphine will also be discussed, including the Drug Enforcement Administration’s strict regulation of the drug’s prescribing practices.  For context: Some GOP and Democratic lawmakers are united against a proposed rule from the DEA that would scale back pandemic-era law waivers that allowed providers to prescribe buprenorphine and other controlled substances, like Adderall, via telehealth. Industry Intel MODERNA, MERCK TO PRESENT CANCER COMBO DATA … Moderna is slated to reveal some of the first data on its mRNA personalized cancer vaccine to be combined with Merck’s blockbuster cancer drug Keytruda to treat melanoma. Moderna’s vaccine would coax patients’ immune systems to target their cancer cells. The trial results will be unveiled at the American Association for Cancer Research’s annual meeting Sunday, and the companies will post an abstract for the Phase IIb trial on Friday. … AND MERCK, EISAI TERMINATE CANCER TRIAL — The makers of Keytruda and Lenvima ended a late-stage trial combining the cancer therapies to treat advanced melanoma early after an interim analysis showed the drugs failed to increase overall survival, Merck said Friday. A different trial testing the drugs for use in late-stage colorectal therapy also failed to increase patients’ overall survival, though the companies didn’t clarify whether they would end that trial. Neither study had safety concerns. PEAR THERAPEUTICS LOOKS FOR A BUYER — Prescription digital therapeutic company Pear Therapeutics filed for Chapter 11 bankruptcy Friday. The firm, one of nine companies selected to participate in the FDA’s Digital Health Software Precertification Pilot Program in 2017, said it plans to scale down operations while seeking a sale. The pilot was an effort by the agency to see whether companies with a positive regulatory track record could be given leeway to regularly update medical device software with less oversight than was required previously, but the project was sunset in September 2022. Tobacco NEW HEALTH LOBBYISTS FOR TOBACCO GIANT — Philip Morris International has hired a trio of former Hill and executive branch health policy staffers as it seeks to enter the U.S. commercial market for cigarette alternatives, POLITICO’s Caitlin Oprysko reports. PMI Global Services retained Paul Edattel, Daniel Todd and Nicholas Uehlecke of Todd Strategy Group back in January to lobby on tobacco harm-reduction, FDA oversight and the creation of a harm reduction caucus, according to a newly filed disclosure. Edattel and Todd are both former health counsels on the House Energy and Commerce Committee and the Senate Finance Committee, respectively, while Uehlecke previously worked at HHS and on the House Ways and Means Health Subcommittee. Quick Hits For Kaiser Health News, Charlotte Huff documents the incomplete care cancer patients without insurance face. It is unclear whether plaintiffs will approve Johnson & Johnson’s proposed $8.9 billion settlement deal for damages caused by its talc products, Fierce Pharma’s Kevin Dunleavy reports. Document Drawer The FDA classified a Philips Respironics recall of 1,088 DreamStation devices offering continuous positive airway pressure and bilevel positive airway pressure as a Class I event — the most serious type of recall. The White House’s Office of Information and Regulatory Affairs received a draft guidance on decentralized trials for drugs, biologics and medical devices from the FDA for review on April 7. Review by the office is usually the last step before regulations are published for public consumption. On Monday, CMS issued its Fiscal 2024 Hospital Inpatient Prospective Payment proposed rule, an annual proposed update to the funding hospitals receive for providing care to older Americans covered by Medicare.   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.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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