Written by: Jessie Litwin
On May 1, 2026, the Fifth Circuit Court of Appeals issued a decision—after the state of Louisiana challenged the Food and Drug Administration (FDA)—that reimposed the in-person dispensing requirement for mifepristone by staying the 2023 risk evaluation and mitigation strategy (REMS), effective immediately across the United States. This decision seems to revert the rules regarding mifepristone distribution to the 2021 REMS, which removed the requirement for mifepristone to be dispensed in person; rather allowing it to be sent by mail to women in its pursuit.
In response to this decision, two major Mifepristone manufacturers, Danco and another generic provider, GenBioPro, have filed emergency appeals to the Supreme Court requesting a one-week stay of the decision, giving them time to craft a full appeal to the Court. Justice Alito responded to the emergency appeal by ordering a one-week stay to the Fifth Circuit ruling through May 11, requesting a formal appeal to the Court by that deadline. On May 14, the Supreme Court extended the order to stay the decision until the formal appeal is deciding, or a writ of certiorari is granted to the parties.
What is Mifepristone?
Mifepristone is a drug that is used to end a pregnancy at any point through the first ten weeks of gestation in a medication abortion or to manage a miscarriage. While not the best choice for all women in need of this care, access to Mifepristone allows women the choice of a private, non-invasive, and non-surgical experience in their own home, rather than a hospital procedure, at a time that may already be both emotionally and physically painful.
Why would women need to receive Mifepristone via mail?
Access to Mifepristone by mail, as afforded to women through the 2021 REMS, makes this drug accessible to those who cannot afford to travel to a clinic, or who do not have a nearby physician to visit for an in-person medication or procedural abortion.
Should the Fifth Circuit’s decision stand on appeal, patients across the country will be vastly impacted by the rule; particularly women in rural communities, those in lower socio-economic communities, and women who are survivors of domestic violence seeking a private and safe avenue for abortion.
Why does this matter now?
Mifepristone accessible by telehealth/mail provides care not only to women seeking abortions, but also to those who have experienced a miscarriage.
Miscarriage
Anywhere between 10% and 25% of all pregnancies in the U.S. end in miscarriage; a figure that has been on the rise by at least 1% year over year. These figures are likely to be underreported, however, due to a lack of research regarding women’s health and the general privacy of the
topic, leading women not to share their experiences. Limiting access to Mifepristone by mail could multiply the difficult nature of a miscarriage for a rising number of women around the country.
Abortion
Since the overturn of Roe v. Wade in 2022, 13 states have independently made abortion completely illegal with limited exceptions, such as access to abortion very early on in a pregnancy. States with these new bans have seen significantly higher rates of pregnancy complications, such as a 50% increase in sepsis rates, a 5.6% rise in infant mortality, and an 8% increase in pregnancy-related deaths among mothers.
Restricting mail access to Mifepristone nationwide could potentially lead to similar outcomes in areas where abortion is legal, but women are unable to access the drug in-person for financial or personal safety reasons. In states where abortion is banned, women would need to travel out of state to find an in-person clinic to receive care, an expense that may not be possible for many. This gets precisely to the heart of Louisiana’s argument; since matters of abortion have been left to the states since 2022, distribution of Mifepristone by mail directly undermines the state’s ability to regulate abortion in bypassing their state ban.
What happens next?
On appeal, among many arguments advanced by Louisiana is one that the FDA’s restriction on telehealth and mail-in use of Mifepristone poses an issue of federalism; that is, which powers lie with the state governments, and which powers lie with the federal government. Louisiana insists that regulation of Mifepristone should be left to the states’ authorities to determine, a position that they argue aligns with the Supreme Court’s ruling overturning Roe, which left issues of abortion to the states. Louisiana, a state with a near-total abortion ban, wants to be left alone to determine how its female citizens can access Mifepristone; and access via mail is not one of the state’s chosen methods.
The FDA, on the other hand, is arguing that its role in federal drug approval is separate and unique from state abortion laws. The FDA deems whether a drug is safe and effective for use and sets the conditions for how the drug may be distributed. These are all functions, it argues, that do not impact a state’s decision to permit or restrict abortions.
While we await formal appeal or a petition for a writ of certiorari, the decision of the Fifth Circuit remains temporarily stayed; allowing business as usual—in other words, the use of mail-in Mifepristone. How the court will decide this in the long run is up in the air; between Justice Alito’s stay of the decision and Justice Thomas’s powerful dissent, the court is split. The case has been remanded back to the Fifth Circuit for a final judgment. However, if the case makes its way to the Supreme Court, a decision isn’t likely to be rendered until the end of this year or early 2027.
Sources:
Amy Howe, Court Allows Access to Abortion Pill by Mail, for Now, SCOTUSblog (May 14, 2026, 5:26 PM), https://www.scotusblog.com/2026/05/court-allows-for-access-to-abortion-pill-by-mail-for-now/.
Louisiana v. Food & Drug Admin., 175 F.4th 310 (5th Cir. 2026).
Sadia Rafiquddin, There’s a Knowledge Gap About Miscarriages in the U.S., and Researchers Hope to Close It, STAT (Aug. 21, 2024), https://www.statnews.com/2024/08/21/miscarriages-poor-data-researchers-explore-causes/.
U.S. Food & Drug Admin., Information About Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation (Jan. 4, 2023), https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation.