What a Pending 5th Circuit Ruling Could Mean for Abortion Pill Access

On September 9, the 5th Circuit Court of Appeals heard oral arguments in Louisiana et al. v. FDA et al., a case challenging the FDA’s regulation of mifepristone (Mifeprex). Mifepristone is a highly safe and effective prescription medication used in terminating early pregnancy and miscarriage management. The drug is used in about 63% of all U.S. abortions, and today, roughly 28% of all abortion patients choose telemedicine abortion over in-person care.

Despite this, FDA’s regulation of mifepristone has been subject to a barrage of litigation, arguably more so than any other drug in history. The Louisiana case is just one of several challenges brought by Republican attorneys generals that aim to disrupt access.

At the same time, groups of abortion providers have challenged FDA’s regulation of mifepristone as excessively restrictive, with two district courts recently ordering FDA to reconsider its restrictions on mifepristone, given the medication’s documented low risk profile.

Alongside all this litigation, FDA is undergoing its own safety review of mifepristone. While women continue to have access to mifepristone for now, various threats — from courts to FDA itself — could mean changes.

FDA’s Regulation of Mifepristone Sparks Litigation

After approving mifepristone in 2000, FDA began regulating mifepristone under a risk evaluation and mitigation strategy (REMS) in 2011. With evidence consistently demonstrating mifepristone’s low risks, the FDA amended its REMS over time to increase the drug’s accessibility.

In 2023, the FDA eliminated a REMS requirement that patients receive mifepristone directly from their provider (in-person), creating a path for patients to access the medication at pharmacies or through telehealth. Prior to this formal change, a federal court had temporarily lifted the in-person dispensing requirement in 2020, and FDA had paused its enforcement in 2021, in light of the COVID-19 pandemic and evidence that this approach was safe.

In the interim was the Dobbs v. Jackson Women’s Health Organization (2022) decision, ending the national right to abortion. Thus, as abortion access was increasing in some states in light of the FDA’s 2023 REMS amendment, it was sharply decreasing in other states that quickly moved to ban or restrict abortion. During this time, several legal challenges against FDA’s regulation of mifepristone arose or were reignited.

Fast forward to present day: there are three separate lawsuits aiming to turn back the clock on FDA’s regulation of mifepristone. One of those lawsuits (brought by Florida and Texas), challenges FDA’s initial approval of mifepristone as well as the agency’s subsequent regulations. Another lawsuit (brought by Missouri, Idaho, and Kansas) challenges regulations dating back to 2016. And the Louisiana case specifically targets FDA’s most recent changes via the 2023 REMS to allow access through telehealth and pharmacies; it is advancing more quickly than these other lawsuits, following Louisiana’s request for emergency relief.

Louisiana Lawsuit Challenges Telehealth Access Nationwide

In 2025, Louisiana officials and one state resident sued the FDA, arguing that the agency acted unlawfully and failed to engage in reasoned decision-making in issuing the less restrictive 2023 REMS. The plaintiffs argue that the removal of the in-person dispensing requirement harms state residents, increases Medicaid expenditures for abortion care in emergency departments, and hinders the state from enforcing its strict abortion bans.

Earlier this year, a Louisiana district court agreed with the Trump administration’s request to pause the case while FDA completes its “safety review.” A 5th Circuit panel promptly reviewed that decision on appeal, and ordered the in-person dispensing requirement to be reinstated. Yet, at the request of drug companies Danco and GenBioPro, the Supreme Court weighed in and ruled 7-2 that telemedicine and pharmacy access to mifepristone be preserved while the litigation continues.

The case is now back at the 5th Circuit and was heard by a different three-judge panel, including judges Dana Douglas (a Biden appointee), Stephen Higginson (an Obama appointee), and Priscilla Richman (a George W. Bush appointee). During oral arguments on September 9, all three judges seemed skeptical that Louisiana’s alleged harms bear a close enough connection to the FDA’s 2023 REMS modification. Importantly, Judge Richman recognized that FDA never “approved the mailing of this drug into states where it’s unlawful”; it merely lifted a national in-person dispensing requirement that states were free to maintain or go beyond with further restrictions. The judges also pointed to other measures, such as state shield laws, that likely play a bigger role in abortion medication being mailed into states with abortion bans.

What a 5th Circuit Decision Could Mean

The 5th Circuit could issue a decision at any time. Meanwhile, all eyes will turn to the outcome of FDA’s safety review, with FDA owing the district court a status update on October 7, 2026.

Even if the 5th Circuit ultimately issues a decision favorable to the FDA and mifepristone’s manufacturers (e.g., that Louisiana lacks standing to sue the FDA), such a victory would likely be short-lived — as that decision could then be taken up by the full 5th Circuit or appealed to the Supreme Court. In short, regardless of the outcome at this stage, Louisiana’s attack on the 2023 REMS will continue to pose threats for some time.

If Louisiana is ultimately victorious in its aim, abortion patients nationwide could no longer legally access mifepristone at local pharmacies or through the mail, as they have done for over 5 years. Instead, patients would have to travel to pick up the medication directly from their healthcare provider. This measure adds no level of safety or protection, while imposing enormous burdens on women, especially those living in rural areas or healthcare deserts far from clinicians; those lacking reliable transportation, childcare, or time off school or work; or those experiencing domestic violence or other heightened privacy needs. As a result, delayed abortion and forced continuation of pregnancy will heighten risks to physical and mental health.

Louisiana asserts that about 1,000 women in the state are obtaining mifepristone each month. It is also worth noting that Louisiana consistently ranks among U.S. states with the highest maternal mortality rates (second only to Tennessee) at 40.7 deaths per 100,000 live births. This is no coincidence, as studies demonstrate that statewide abortion bans are associated with a 9.2% increase in pregnancy-associated deaths, with glaring racial inequities.

While Louisiana argues that the state itself is somehow harmed, a decision for Louisiana would disrupt access for the hundreds of thousands of patients in states where abortion is lawful who want to obtain mifepristone at pharmacies and through the mail. Against the Dobbs decision holding that abortion policy is a state-by-state matter, a decision for Louisiana would impose one state’s abortion policy on the rest of the country by undermining an evidence-based FDA determination that applies nationwide.