FDA Says Mifepristone Safety Review Will Run to March 2027, Keeping Mail Access in Place for Now
The FDA told a Louisiana court it expects study results by mid-December and plans to finish its mifepristone safety review by March 2027, while a Supreme Court order keeps telehealth prescribing and mail dispensing available in the meantime.
Access to the abortion pill mifepristone by telehealth and mail will remain unchanged for months after the Food and Drug Administration told a federal court in Louisiana that its safety review will not finish until 2027.
In a status report filed Oct. 7, government lawyers said the agency expects to receive study results by mid-December 2026 and to complete its review no later than March 2027, according to STAT reporting summarized by GhanaMMA. A Supreme Court order issued in May keeps telehealth prescribing and mail or pharmacy dispensing in place while the case continues, according to the report.
A lawsuit over the 2023 telehealth rule
Louisiana Attorney General Liz Murrill sued the FDA in October 2025, joined by a Louisiana resident, challenging the agency’s 2023 decision to allow telehealth prescribing and mail dispensing, according to the report. U.S. District Judge David C. Joseph left the 2023 rule in place on April 7 but paused the case until the FDA finishes its review, according to the report.
The dispute moved quickly after that. According to the report, a 5th U.S. Circuit Court of Appeals panel sided with Louisiana on May 1 and reinstated an in-person dispensing requirement nationwide; the Supreme Court paused that ruling on May 4 and on May 14 kept telehealth and mail access in place, with Justices Clarence Thomas and Samuel Alito dissenting. At a Sept. 9 hearing, several appeals judges questioned whether Louisiana had shown enough harm to sue, according to the report, though the Supreme Court order means any 5th Circuit ruling would not immediately change access.
What the FDA is studying
According to the filing coverage, the agency is using a statistical data-mining method known as a TreeScan analysis of Sentinel health-system and insurer data to look for previously unknown safety concerns, comparing mifepristone with surgical abortion through 10 weeks of pregnancy and measuring side effects among roughly 100,000 women who took the drug. It is also reviewing the drug’s Risk Evaluation and Mitigation Strategy program and petitions that ask it to restore the in-person dispensing requirement dropped in 2023, according to the report.
Medication abortion accounts for more than two-thirds of U.S. abortions, according to KFF, cited in the report. Abortion opponents criticized the longer timeline, with Americans United for Life’s Gavin Oxley saying the administration was uninterested in addressing what he described as harms from the pill, according to STAT. After the review, according to the report, the FDA could keep the current rules, restore in-person dispensing, or make other changes.
Reporting based on coverage by STAT, as summarized by GhanaMMA.
