SCOTUS Preserves Mifepristone Telehealth Access as FDA Launches Safety Study

The U.S. Supreme Court on May 14 allowed the abortion pill mifepristone to remain available through telehealth prescribing and mail delivery, granting an administrative stay that paused a Fifth Circuit Court of Appeals ruling restricting access while the Louisiana v. FDA case proceeds. The decision preserves the FDA's 2023 policy that permanently removed the in-person dispensing requirement for mifepristone.

On May 1, the U.S. Court of Appeals for the Fifth Circuit granted Louisiana's request to pause the FDA's 2023 decision permitting mifepristone to be dispensed by mail, temporarily halting both telemedicine prescribing and mail distribution nationwide. The manufacturers Danco Laboratories and GenBioPro filed a stay application with the Supreme Court, which issued a one-week administrative stay pausing the Fifth Circuit ruling until May 11. Associate Justice Samuel Alito extended the stay until May 14 at 5 p.m., and the full Court then granted the stay, allowing the policy to remain in place while the case returns to the Fifth Circuit for consideration on the merits. Alito issued a dissenting opinion.

Mifepristone was approved by the FDA in September 2000 for medical termination of pregnancy through 7 weeks of gestation and extended to 10 weeks in 2016. It is deemed safe when used as indicated and consistent with the risk evaluation and mitigation strategy (REMS) program. Mifepristone has a REMS classification, one of approximately 73 drugs with such status, and also carries an FDA Black Box Warning. The REMS for mifepristone were loosened in steps over time, including the removal of an initial in-person doctor visit to screen for ectopic pregnancy and a follow-up visit to check for complications, as well as the elimination of the requirement that abortion providers report non-fatal adverse events to the FDA Adverse Event Reporting System. In January 2023, the FDA permanently removed the in-person dispensing requirement and allowed dispensing by mail and pharmacies.

Mifepristone plus misoprostol is the most common combination used for medical abortion in the U.S. Medical abortion accounts for about two-thirds of U.S. abortions and is used to terminate a pregnancy within the first 10 weeks. Approximately 1 in 4 abortions are prescribed via telehealth nationally, and 29% of abortions are now provided via telehealth, according to the latest data. Research has shown that telehealth for medication abortion is just as safe and effective as in-person care.

The FDA has launched a safety study of mifepristone, a step that could pave the way for the Trump administration to restrict how the drug is distributed and used. The FDA has said mifepristone continues to be safe and effective when used as directed. The study, which has the White House's backing, would use existing drug-safety systems, is expected to take six months and is intended to withstand legal criticism. The FDA is also considering hiring a contractor to acquire and analyze data on mifepristone use. Some officials expected preliminary internal results in July, with full results unlikely to be completed before November's midterm elections.

The New York State Department of Health reaffirmed its commitment to protecting reproductive freedom and ensuring continued access to medication abortion, noting that mifepristone remains available through telehealth, mail delivery and in-person care. The state health commissioner stated that mifepristone remains a safe, effective and available option for abortion care in New York. The governor recently announced additional investments through the New York State Supplemental Abortion Provider Support Program.

Anti-abortion groups criticized the Supreme Court decision. National Right to Life said the decision leaves women exposed to powerful abortion drugs and that ongoing concerns include incomplete adverse event reporting, emergency room visits linked to chemical abortion complications, and the lack of meaningful long-term study of increasingly unrestricted distribution of abortion drugs. The president of Heartbeat International stated that women deserve better than dangerous abortion drugs sent through the mail without physician oversight or in-person support. Louisiana has argued that the FDA failed to adequately consider the impact on women's health, emergency medical systems, and state authority to regulate medical practice.