How will FDA play into Biden’s abortion fight?

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

Jun 28, 2022 View in browser   By Lauren Gardner and David Lim On Tap — The Biden administration has signaled that FDA approval of mifepristone will underpin part of its legal strategy on abortion. — The FDA prepares to consider Omicron-specific formulations for Covid-19 vaccines. — More drugs might be available for sale without a prescription if a new FDA proposal is finalized. It's Tuesday. Welcome to Prescription Pulse. Taking a page from our West Wing Playbook colleagues' book: Are you Senate HELP Committee Republican senior counsel BARRETT TENBARGE? We want to hear from you about the user fee package preconference. Send tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). Eye on the FDA The reversal of Roe v. Wade raises questions about nationwide access to medication abortion. | Charlie Neibergall/AP Photo THE ROAD FORWARD ON ABORTION PILLS — Friday's Supreme Court decision overturning the constitutional right to abortion and returning the issue to the states recasts attention toward the FDA and its lane on the issue: What does this mean for access to medication abortion nationwide? While nearly two dozen states are poised to ban the procedure in the coming weeks — or have already done so — overturning Roe v. Wade raises questions about the implications of patient access to mifepristone, a drug blocking a key pregnancy hormone that the FDA approved in 2000. It's taken in combination with a second drug, misoprostol, that induces contractions. Some legal scholars who favor abortion rights argue the FDA should assert that its drug-approval decisions preempt actions by states to limit or ban use of mifepristone. The notion of preemption, which derives from the Constitution's supremacy clause, says that federal law trumps state law when the two conflict. "It's not entirely clear that this legal strategy would win, but I think that it has an extraordinarily strong case behind it," Lawrence O. Gostin, a Georgetown University law professor, told Prescription Pulse. "When FDA approves a drug as being safe, effective, with the best national scientific evidence, it sets a national uniform standard that states cannot contradict." Hints and questions: Statements issued by President Joe Biden, HHS Secretary Xavier Becerra and Attorney General Merrick Garland in the hours after the court's decision indicated the FDA's approval of mifepristone, already subject to stringent oversight under the agency's Risk Evaluation and Mitigation Strategy, could be a major focus of the administration's legal strategy on abortion. But for now, the FDA remains publicly cautious about its role in any future legal battle over the drug's use in states poised to ban or further restrict medication abortions, which regulators have permitted up to 10 weeks of pregnancy. "Patients should have access to medications that are safe and effective for their FDA-approved use," the FDA said Friday in an unattributed email statement. "In this area, as in all others the FDA regulates, the best available science will continue to guide Agency decision-making." Greer Donley, an assistant professor specializing in reproductive health care at the University of Pittsburgh Law School, said she expects the FDA to remain cautious on the issue after decades of attacks from both sides accusing regulators of partisan behavior — even though its authority is "one of the main tools the Biden administration has at its disposal to promote abortion access" post-Roe. Case to watch: GenBioPro, the manufacturer of generic mifepristone, has already challenged a Mississippi law that effectively banned telehealth abortions by making patients see doctors in person to obtain the drug, even though the FDA ended its requirement that the pills be personally doled out in 2021. More reading: POLITICO's Ben Leonard examines what could be next for virtual abortions after Roe, including the FDA's role in the practice. POLITICO's Sarah Owermohle reports that senior Biden officials are pressing insurers to ensure they're complying with Affordable Care Act requirements to provide no-cost contraceptives to enrollees. Justice Clarence Thomas argued in a concurring opinion on Friday that the high court "should reconsider" its past ruling codifying the right to contraception access , along with other decisions that hinged upon Americans' fundamental privacy, due process and equal protection rights, POLITICO's Quint Forgey and Josh Gerstein write. FDA FLOATS NEW NONPRESCRIPTION DRUG PATH — Drugmakers might eventually be able to add new requirements on nonprescription drugs — such as having consumers, as a condition of purchase, fill out and pass a test to ensure they understand how to use a drug appropriately — which would make more drugs accessible without a prescription. The new pathway, presented in a proposed rule published in the Federal Register on Monday , would be used when labeling alone is inadequate to ensure consumers can self-select or appropriately use a drug in a nonprescription setting. The FDA is collecting comments on the proposal for 120 days. "As part of the FDA's ongoing efforts to improve public health, this proposal can broaden the types of drugs that can be approved as non-prescription — increasing availability of drugs that would otherwise only be available by prescription," FDA Commissioner Robert Califf said in a statement.   DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.     The FDA is weighing whether a strain update to Covid-19 boosters is warranted. | Emily Elconin/Getty Images Coronavirus FDA GEARS UP FOR COVID BOOSTER DEBATE — The FDA's independent vaccine advisers will meet today to deliberate and vote on whether to recommend that the agency green-light new Covid-19 vaccine recipes that contain Omicron-specific components as versions of the variant dominate the U.S.' disease trajectory. The debate comes as the original formulations continue to protect against severe disease, hospitalization and death for most Americans, even as efficacy against symptomatic disease rapidly drops off months post-inoculation. The contenders: Pfizer, Moderna and Novavax are scheduled to present new data on clinical trials of their variant booster candidates. Moderna said last week that its Omicron-specific booster shot induced promising antibody responses against the BA.4 and BA.5 subvariants. Pfizer and BioNTech said Saturday that their monovalent Omicron booster — formulated to target only that variant lineage — induced high neutralizing antibody levels against the original Omicron strain at 30-microgram and 60-microgram dose levels, while their bivalent Omicron booster in the same doses — made to target both that variant and the novel virus that emerged in 2019 — elicited a decent, though lower, antibody boost. Early lab studies showed both booster candidates responded to the BA.4 and BA.5 strains but to a lesser extent than they did to the first Omicron variant, the companies said. The debate: The FDA is asking its advisory committee to consider whether a strain update to the vaccines is warranted now, whether a specific sub-lineage of variant should be targeted and whether the shot should be formulated to target just Omicron or Omicron and the original virus. The committee will also have to weigh how the boosters might perform among different age groups — Pfizer studied its candidates in people 56 and older, while Moderna studied adults of all ages (though the average age was 57). The pressure is on for regulators to make a decision quickly, as manufacturers will need some lead time to manufacture variant-specific shots in time for an anticipated fall booster program. CDC RECOMMENDS MODERNA SHOT FOR MORE KIDS — The CDC last week officially recommended Moderna's Covid-19 vaccine for children ages 6 to 17, Lauren reports. Around the Agencies CMS INTRODUCES NEW ONCOLOGY MODEL — Oncology practices may participate in a new voluntary model unveiled by the Centers for Medicare and Medicaid Services on Monday that builds on the Center for Medicare and Medicaid Innovation's Oncology Care Model that was operational from July 2016 to June 2022. The new five-year program, called the Enhancing Oncology Model , targets Medicare patients undergoing chemotherapy for breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer and small intestine or colorectal cancer. Applications are due by Sept. 30. "The Enhancing Oncology Model will incentivize participating oncology practices — including those in rural and underserved areas — to improve the provision of high-quality, coordinated care that addresses patients' social needs and improves patient and caregiver support," CMS Administrator Chiquita Brooks-LaSure said. UCB VIOLATING 340B STATUTE, HRSA SAYS — The Health Resources and Services Administration warned biopharmaceutical company UCB on Monday that its restrictions on offering 340B pricing to "covered entities that dispense medications through pharmacies under contract" must be remedied. "HRSA expects UCB to provide an update on its plan to restart selling, without restriction, 340B covered outpatient drugs at the 340B price to covered entities with contract pharmacy arrangements by July 11, 2022," HRSA Administrator Carole Johnson wrote in a letter.   INTRODUCING POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don't miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY.     Tobacco JUUL: FDA PROHIBITION WOULD 'HARM THE PUBLIC' — Lawyers argued in a Monday filing that the FDA's decision to deny Juul's marketing applications for its products holds it to a different standard than its competitors and reflects "a larger pattern" of the agency "singling out" the company. The filing, which follows a temporary administrative stay issued Friday by the U.S. Court of Appeals for the D.C. Circuit, argues that removing Juul products from the market while the appeal is pending may cause former adult smokers to take up cigarettes again. The company is asking for the court to stay the FDA's decision pending review. Document Drawer The FDA on Friday issued final guidance for companies submitting alternative electronic applications exempt from an electronic common technical document format submission. The FDA on Friday issued final guidance with recommendations for companies planning to study the impact of food-drug interactions of oral drug products to support an application.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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