Abortion pill’s hazy legal future

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Jun 14, 2024 View in browser   By Lauren Gardner and David Lim Presented by  Driving The Day Despite a Supreme Court ruling favoring continued access to mifepristone, more legal challenges to the abortion drug could be on the horizon. | Anna Moneymaker/Getty Images WHAT’S NEXT FOR MIFEPRISTONE — The Biden administration and allies in and outside of government applauded the Supreme Court’s unanimous decision Thursday to maintain access to the abortion pill mifepristone. But don’t expect legal fights over the drug to fizzle just yet. The ruling didn’t address the merits of the challengers’ case against FDA policy changes that expanded access to the drug, raising the question of what’s to come. “Let us not forget: This decision was based not on the merits, but on the lack of standing — we are not yet out of the woods,” Senate Majority Leader Chuck Schumer said on the chamber floor. The decision won’t end the political maelstrom around abortion pills, which are banned or restricted in many states, and it doesn’t preclude a future Republican administration or Congress from creating more roadblocks for the medication’s access. And because the ruling was limited to the anti-abortion doctors’ standing to sue the FDA, it doesn’t eliminate future legal risk to the agency’s authority — though it won’t be easy for prospective challengers. Idaho, Kansas and Missouri intervened on behalf of the plaintiffs at the district court level, and they will seek to assert standing to keep the case alive. “I do struggle a little bit to think of what that future case might look like,” said Eva Temkin, a former FDA counsel now at Arnold & Porter. “I really do struggle to see how those intervenors could have standing” given the court’s ruling. Generally, the court not addressing the merits means that existing case law continues to hold, Temkin said. “I think it’s clear FDA has scientific decisionmaking [power] over these questions,” she added. But Mary Ziegler, a professor at UC Davis School of Law, said abortion opponents can draw hope from the court’s silence. “It just kicks the can down the road,” she said. “The court didn't say anything to suggest any skepticism of the plaintiffs’ claims on the merits.” FDA weighs in: In a sea of lengthy statements from Democrats and officials like HHS Secretary Xavier Becerra about the decision, FDA Commissioner Robert Califf kept his reaction short and to the point. “We are pleased with the Supreme Court’s decision,” he said. “Under that decision, mifepristone remains available under the conditions of use approved by FDA.” IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Did you partake in the annual ice cream party on the Hill this week? We won’t judge if you’re Team Dairy or Team Oatly. Send scoops (see what we did there?), news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).   A message from Evernorth Health Services: Medication people can't afford can't make a real impact. Evernorth is giving plan sponsors a financial pathway to cover GLP-1s for weight loss. That's wonder made possible. Learn more here.   In Congress Sen. Bernie Sanders is threatening to subpoena Novo Nordisk. | Francis Chung/POLITICO SANDERS’ SUBPOENA SHOWDOWN — Novo Nordisk and Sen. Bernie Sanders (I-Vt.) continued their war of words this week, with tensions escalating ahead of a committee subpoena vote scheduled for Tuesday that — as of now — shows no signs of being called off. In a letter obtained by Lauren, the Danish drugmaker asserted Wednesday that Sanders, chair of the Health, Education, Labor and Pensions Committee, has mischaracterized the nature of the discussions between the company and his staff about the hearing, slated to focus on the higher cost of its blockbuster diabetes and weight-loss drugs Ozempic and Wegovy in the U.S. than in other countries. Novo’s counsel wrote that the global CEO had agreed to testify once the parties figured out the hearing logistics — which she said is standard operating procedure when lawmakers ask companies to appear before Congress — and that Sanders’ statements suggesting the company has rejected his overtures are “simply untrue.” Sanders spokesperson Anna Bahr countered that it’s at the senator’s discretion to call hearings and determine witness lists. She also called Novo’s request that the hearing be scheduled in the fall at the end of the chamber’s work period before election season and to include other companies “a bit insulting.” Will they or won’t they: Senate HELP Committee members who Lauren caught up with on Wednesday played coy about whether they plan to support Sanders’ subpoena effort. But at least a few senators signaled they’re likely to back it. “I know that it doesn’t always feel this way to a witness, but I think it’s an honor to be asked to come into the Senate,” Sen. Tim Kaine (D-Va.) said. “And I certainly believe this is a hearing that is really important for us.” He added that while he’d like to hold a hearing with multiple witnesses to address the various factors behind drug prices, “I do think it’s an opportunity for them, too, and it’s definitely going to be educational for us.” Retiring GOP Sen. Mike Braun of Indiana, who’s shown a willingness to poke drug companies and pharmacy middlemen over their influence on drug costs, wouldn’t rule out supporting a subpoena.   THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists. Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.     Eye on the FDA ADCOMM ADVICE — The FDA kicked off the public-facing portion of its Great Adcomm Rethink on Thursday with a nearly daylong town-hall style meeting — though still virtual — taking comments on various aspects of the panels’ structure and use in helping the agency make drug approval decisions. “Disagreements in interpretation between our staff and advisers should not always be regarded as a negative,” Califf said in opening remarks. “If we always agreed, we wouldn’t need advice.” Dozens of speakers weighed in with opinions about agency vetting of who speaks during public comment sessions at meetings, the practice of voting to indicate where an advisory committee stands on an issue and addressing potential conflicts of interest among panel members.   A message from Evernorth Health Services:   FDA: GUNS AREN’T MEDICAL DEVICES — The FDA rejected Thursday a long-shot citizen petition asking the FDA to regulate guns and ammunition as medical devices. “FDA is declining to use the Agency’s resources in this way,” wrote Ellen Flannery, deputy center director for policy in the FDA’s device unit. “This is taking into account the broad scope and overall workload of the Agency and its priorities, as well as, which your petition recognizes, the complexities of the issues, including whether Congress intended FDA to regulate guns and/or ammunition for guns."   SUBSCRIBE TO GLOBAL PLAYBOOK: Don’t miss out on POLITICO’s Global Playbook, our newsletter taking you inside pivotal discussions at the most influential gatherings in the world. Suzanne Lynch delivers the world's elite and influential moments directly to you. Stay in the global loop. SUBSCRIBE NOW.     Document Drawer The Government Accountability Office issued a scathing report urging the FDA to improve its inspection and recall process for infant formula after inadequate policies hindered a prompt response to the Abbott crisis in 2022. The FDA formally recommended that updated Covid-19 vaccines for the fall target the JN.1-lineage KP.2 strain — a decision the agency does not anticipate will delay availability of the shots.   A message from Evernorth Health Services: Evernorth Health Services is addressing one of health care's biggest challenges: rising costs. Evernorth is giving plan sponsors a financial pathway to cover GLP-1s for weight loss. Through clinical expertise and lifestyle benefits, Evernorth is helping patients and plans lower costs while improving outcomes. That's wonder made possible. Learn more here.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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