Today, the Fifth Circuit will hear oral arguments in Alliance for Hippocratic Medicine v FDA, the next step in the tumultuous litigation that challenges the U.S. Food and Drug Administration’s (FDA) approval of mifepristone, one of the two drugs most commonly used in a medication abortion. This lawsuit has gone through several twists and turns starting with the initial district court ruling from Judge Matt Kacsmaryk, which would have stayed the FDA’s 2000 approval of mifepristone and potentially removed the drug from the market. After a contradictory ruling from a district court in Washington and an order from the Fifth Circuit to partially stay Kacsmaryk’s ruling, the Supreme Court blocked the district court ruling and remanded the case back to the Fifth Circuit. This brings us to today where the Fifth Circuit will consider the FDA and Danco’s appeal of Kacsmaryk’s stay of the FDA approval of mifepristone, the next chapter of what is likely to be a long and complicated legal process.
The turmoil surrounding mifepristone access comes on the heels of important changes at the federal level to expand access to medication abortion. In January 2023, the FDA announced permanent changes to the mifepristone Risk Evaluation and Mitigation Strategy (REMS), a drug safety program that imposes restrictions on the provision of certain drugs. NHeLP recently published guidance on pharmacist-dispensed medication abortion, including the policy changes that are needed to facilitate insurance coverage in both public and private plans, due to the mifepristone REMS changes.
The confusing and rapidly shifting legal landscape created by this litigation raises important questions about the future of pharmacist-dispensed mifepristone in the US. As this legal battle continues, insurers and pharmacy benefit managers should continue their work to ensure that medication abortion is added as a pharmacy benefit. The Supreme Court’s ruling will remain in effect as the litigation progresses, which means mifepristone will remain legal and accessible until and unless the Supreme Court weighs in on the case again. The ongoing litigation has no impact on the ability of payers to create and implement the systems and infrastructure to support insurance coverage of pharmacist-dispensed mifepristone. After all, this work to update formularies and create verification systems for REMS compliance should be underway already; the FDA announced the new permanent changes to the mifepristone REMS in January of this year, over three months ago.
Furthermore, even in a world where the FDA is forced to revoke mifepristone’s approval, payers should ensure coverage of misoprostol-only regimens for medication abortion. The misoprostol-only regimens are commonly used internationally, and providers across the country have prepared to make the pivot to this protocol if the anti-abortion activists behind the legal challenge to mifepristone’s FDA approval are successful. This means pharmacy-dispensed medication abortion will remain a viable and needed service delivery model, regardless of the outcome of the current legal battles.
While we’ve seen major shifts in the legal landscape for mifepristone over the last several months, it would be a grave disservice to patients if insurance companies and pharmacy benefit managers used the current legal turmoil as an excuse to pause work on adding medication abortion as a pharmacy benefit. Comprehensive insurance coverage is a crucial component of creating an equitable abortion access landscape. Now more than ever we urge insurers to prioritize these reforms and make the necessary changes to ensure pharmacy-dispensed medication abortion is accessible to all who need it.