Summary

Summary

Louisiana v. FDA was filed by the state of Louisiana against the U.S. Food and Drug Administration (FDA) in October 2025. Louisiana seeks to restrict access to the abortion pill mifepristone through the nationwide reinstatement of a medically unnecessary in-person dispensing requirement. Mifepristone has been FDA-approved since 2000 and its safety has been established by decades of use and science.

Reinstating the in-person dispensing requirement would force patients across the country to travel to a health center to be handed the medication. It would end mail distribution of mifepristone, and it would stop pharmacies from filling mifepristone prescriptions for all patients, including those who need it for miscarriage management.

The Trump administration is currently conducting its own politically-motivated “review” of mifepristone. In January 2026, the FDA asked the court to hold off on ruling until the administration’s review is finished, with many suspecting the administration will ultimately reinstate restrictions on mifepristone anyway. The district court granted this request in April 2026, pausing the case to give the FDA time to conduct its “review.” It also denied a request from Louisiana to temporarily reinstate the in-person dispensing requirement while the case is being litigated.

Louisiana appealed this decision to the Fifth Circuit of Appeals and, on April 17, 2026, asked the Fifth Circuit to reinstate the in-person dispensing requirement while that appeal proceeds. On May 1, 2026, the 5th Circuit Court of Appeals granted that request, temporarily reinstating the in-person dispensing requirement and limiting access to abortion pills across the country.

While the order was in effect, there was chaos and uncertainty as providers sought to change their practices with no notice. On May 2, 2026, Danco Laboratories and GenBioPro—two pharmaceutical companies that manufacture mifepristone and have intervened as defendants in the case—asked the U.S. Supreme Court to stay the Fifth Circuit’s ruling. On May 4, 2026, the Supreme Court temporarily paused the ruling while it considered arguments for a stay.

On May 14, 2026, the Supreme Court granted a stay of the Fifth Circuit’s order, allowing people to continue to access mifepristone by mail and at pharmacies as the case proceeds. The case will now be sent back to the Fifth Circuit for full briefing and argument. It will likely make its way back to the Supreme Court after that.

Background

Background

Medication abortion—in the U.S., most commonly a two-drug regimen of mifepristone and misoprostol—accounts for more than 60% of abortions in the U.S. each year. A quarter of all abortions in the U.S. are now provided via telehealth—a two-fold increase since Roe v. Wade was overturned. Telehealth has been a lifeline, particularly for patients who are far from clinics, where the nearest provider could be hours away.

Hundreds of studies confirm mifepristone’s safety, and 7.5 million Americans have used the drug since it was approved by the FDA in 2000. Research shows mifepristone is just as safe when provided via telehealth as it is in a clinic.

Louisiana v. FDA is one of several court cases brought by ban states that seek to restrict access to mifepristone nationwide. Ongoing cases in Texas and Missouri could go even further, including by directing the FDA to withdraw its approval of mifepristone altogether, or by finding that the Comstock Act—a Victorian-era law—prohibits the mailing of all abortion pills and other items used in abortion care.

In addition, sustained external pressure on the Trump Administration from anti-abortion advocates and politicians led Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. to ask FDA Commissioner Marty Makary to “review” the latest data on mifepristone. Due to an April 7, 2026 ruling in Louisiana v. FDA, the FDA will be required to file a status report on its progress no later than October 7, 2026. Neither HHS nor the FDA has provided any clarity or transparency regarding the basis of this “review,” including what data sources they are using to conduct it, despite repeated calls from the public, including from the Center and other advocacy organizations, as well as from Congress.

About the case

About the case

Louisiana v. FDA (W.D. La.) was filed by the anti-rights group Alliance Defending Freedom on behalf of Louisiana and an individual woman in October 2025.

On December 17, 2025, Louisiana filed a motion with the district court to immediately reinstate the in-person dispensing requirement while the case is being litigated. In response, the FDA asked the district court to put the case on hold while it continues its ongoing review of mifepristone regulations. A hearing was held on February 24, 2026. Read the amicus briefs submitted in this case by a broad range of experts, including the Center for Reproductive Rights, here.

On April 7, 2026, the district court granted the FDA’s request to pause the case while the FDA conducts its review. This decision meant that there would be no immediate changes to the federal rules governing mifepristone. The district court did not set a deadline for the FDA to complete its review, but did order the FDA to file a status report within six months (no later than October 7, 2026) updating the court on the FDA’s progress. 

Louisiana appealed the district court’s decision to the Fifth Circuit Court of Appeals the very next day. Danco and GenBioPro cross-appealed, challenging the district court’s denials of their motions to dismiss. On April 17, 2026, Louisiana asked the Fifth Circuit to enter an order reinstating the in-person dispensing requirement nationwide while its appeal is pending. On May 1, 2026, the 5th Circuit Court of Appeals granted Louisiana’s request, temporarily reinstating the requirement.

On May 2, 2026, Danco Laboratories and GenBioPro—two pharmaceutical companies that manufacture mifepristone and have intervened as defendants in the case—filed stay applications with the U.S. Supreme Court, asking the Court to preserve the status quo. As part of their applications, Danco and GenBioPro sought an immediate administrative stay while the Supreme Court considers their requests. Danco and GenBioPro also request that, in the event the Supreme Court denies their applications, the Court agree to hear the case.

On May 4, 2026, the Supreme Court granted a one-week administrative stay of the Fifth Circuit’s order, which it then extended through May 14, 2026. The ruling protects the status quo, allowing mifepristone prescriptions to be filled by mail or at a pharmacy while the Court considers the stay applications more fully. Louisiana filed a response to Danco and GenBioPro’s applications to stay on May 7, 2026. On May 8, Danco and GenBioPro filed replies to Louisiana’s response.

On May 14, 2026, the Supreme Court granted a stay of the Fifth Circuit’s order. The ruling protects the status quo, allowing mifepristone prescriptions to be filled by mail or at a pharmacy as the case proceeds. The case will be sent back to the Fifth Circuit for full briefing and argument. It will likely make its way back to the Supreme Court after that.

Related resources Timeline Legal documents