FDA tells court abortion pill review will not finish until after the election

The Food and Drug Administration told a federal court on October 7 that it expects results from its safety study of the abortion pill mifepristone by mid-December and will finish its review no later than March 2027, according to Medical Daily’s account of the agency’s status report in Louisiana v. FDA. Telehealth prescribing and mail delivery of the drug, which a 2023 rule allowed, remain in place while the review and the litigation continue.

The disclosure came 12 days before President Donald Trump signed an executive order creating a women’s health division at the National Institutes of Health. The order’s text, titled “Advancing Women’s Health to Improve Outcomes in All Phases of Life,” does not mention abortion or contraception.

The lawsuit

Louisiana Attorney General Liz Murrill and a Louisiana resident, Rosalie Markezich, sued the FDA in October 2025, according to Medical Daily. KFF’s explainer reported that the state claims the agency violated the Administrative Procedure Act when it approved the 2023 mifepristone safety program, and that the program violates the Comstock Act, an 1873 law that prohibits mailing any medication used for abortion. Louisiana argues that mailed dispensing harms its ability to enforce its abortion ban and has cost its Medicaid program money. KFF said the state cited $92,000 in Medicaid costs for two women who needed emergency care in 2025.

On April 7, 2026, U.S. District Judge David C. Joseph of the Western District of Louisiana stayed the case so the FDA could finish its review, according to the April 7 ruling. He declined to order an immediate end to telemedicine prescribing and mail dispensing. In the same ruling, he concluded that the plaintiffs were likely to succeed on the merits of their challenge to the 2023 rule, citing the FDA’s own acknowledgment of “the lack of adequate consideration underlying the prior REMS approvals.”

The judge wrote that the stay would not be open-ended. “FDA has an obligation to act with all deliberate speed to review its past actions and complete a thorough analysis that addresses the deficiencies it has acknowledged,” he wrote. He ordered a status report within six months and notice to the court within 14 days of the review’s completion, according to Medical Daily.

The appeals

Louisiana appealed. On May 1, a three-judge panel of the Fifth Circuit reinstated in-person dispensing nationwide while the appeal proceeded, KFF reported. On May 14, the Supreme Court blocked that order, leaving the 2023 rules in place. Medical Daily reported that Justices Clarence Thomas and Samuel Alito dissented.

The Fifth Circuit heard arguments on September 9, and several judges questioned whether Louisiana has standing, according to Medical Daily. It said any ruling would not immediately change access because of the Supreme Court’s order. KFF noted that the FDA and the drug’s manufacturers argue that Louisiana’s Medicaid-based harm is too attenuated to establish standing.

What the FDA says it is studying

The October 7 status report said the agency is reviewing a statistical data-mining method called TreeScan, meant to identify unknown safety concerns using data from the FDA’s Sentinel system on use through 70 days of pregnancy, according to Medical Daily. The FDA plans to compare mifepristone’s safety with surgical abortion through 10 weeks and to measure side-effect rates among roughly 100,000 women who took the drug. It is also reviewing the safety program and pending citizen petitions, some of which ask the agency to restore the in-person dispensing requirement that it dropped in 2023.

On its own question-and-answer page, the FDA says mifepristone is safe when used as indicated and directed. The page says that as of December 31, 2024, the agency had received 36 reports of deaths in patients associated with the drug since its approval in September 2000, and that its review of that information identified no new safety signals. KFF reported that the agency’s 2023 review found no new safety concerns related to removing the in-person requirement, and Medical Daily, citing KFF, said medication abortion accounts for over two-thirds of U.S. abortions.

Reactions

Murrill said the judge concluded Louisiana is likely to succeed in showing that the 2023 rule is unlawful, according to Medical Daily. Julia Kaye, a senior staff attorney at the American Civil Liberties Union’s Reproductive Freedom Project, called the pause “certainly a better outcome than what Louisiana asked for.” Gavin Oxley of Americans United for Life told STAT, as quoted by Medical Daily, that the administration is “clearly uninterested in mitigating the ongoing harms caused by the abortion pill.”

The October 19 order

The executive order directs the Secretary of Health and Human Services, acting through the NIH director, to establish a Women’s Health Division within 90 days. It creates a White House Women’s Health Task Force co-chaired by the health secretary and the White House chief of staff. The order names cardiovascular disease, cancer, Alzheimer disease, endometriosis, fibroids, infertility and menopause among the conditions needing more research, and it specifies no funding amount.

The Society for Women’s Health Research, the American College of Obstetricians and Gynecologists and the Women’s Health Research Coalition said in a joint statement welcoming the order that “robust and sustained funding is necessary to meaningfully advance research in women’s health.”