(Oregon Right to Life) — The U.S. Food and Drug Administration (FDA) last week issued a court-ordered update on its abortion pill safety review, announcing it would not complete the much-awaited study until next year. The news comes as a disappointment – but not a surprise – to pro-life advocates who had hoped the agency would more quickly restore regulations on the dangerous drugs.
In an October 7 filing, the FDA indicated that its safety review of the abortion pill mifepristone was ongoing but that it would not be prepared to release its results this year. Instead, it said the review would be finished by March of 2027.
“FDA is on track to obtain study results by mid-December 2026,” the agency said in the filing. “FDA will then need to review and evaluate/interpret the results and draft a report. FDA expects to complete that process not later than March 2027.”
“Following completion of its study and review, FDA will decide whether changes to the Mifepristone REMS (Risk Evaluation and Mitigation Strategies) Program are necessary and, if applicable, initiate any such changes in accordance with established processes. FDA anticipates that it will be able to provide an update to its estimated date of completion as more information becomes known, particularly in March 2027 when it expects to complete its report on the final study results.”
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The FDA’s update was in compliance with a court order associated with a lawsuit lodged by the state of Louisiana against the FDA. The suit contends that Louisiana has been harmed by the FDA’s rollback of regulations on the abortion pill (especially the allowance for online prescription and distribution through the mail), which has weakened Louisiana’s ability to enforce its pro-life laws, KFF reported. The state further asserts that it has had to use nearly $100,000 in state Medicaid funds to treat women who needed emergency care after ordering abortion pills online and suffering complications.
Prior to the FDA’s update, prominent pro-life group Susan B. Anthony Pro-Life America (SBA) urged the FDA to conduct its study with due rigor, but encouraged the Trump administration not to wait until the study is complete to take meaningful action.
“The FDA’s court-ordered October 7 update on its study should ensure that the eventual analysis is truly robust and incorporates all relevant evidence, including commercially available datasets and post-policy Medicaid data,” SBA President Marjorie Dannenfelser said in a statement. “But the administration should not wait for the study’s completion to act. Given that the Biden administration relied on insufficient evidence and flawed assumptions in removing the in-person dispensing requirement, the FDA should restore that safeguard immediately.”
READ: 23 States, Over 100 Lawmakers Call on U.S. Supreme Court to Block Mail-Order Abortion Pills
As Oregon Right to Life previously reported, the FDA initiated its safety review of mifepristone following a 2025 study finding the adverse reaction rate associated with the drug to be over one in ten (10.93%), twenty-two times the rate currently listed on its official FDA label.
The first drug in the abortion pill regimen, mifepristone blocks the action of the growth hormone progesterone, causing the developing human fetus or embryo to effectively die of starvation. A second drug, misoprostol, is taken to expel the unborn baby’s body. Chemical abortion now accounts for well over half of all U.S. abortions amid the rollback of federal regulations over the past decade, especially the Biden-era elimination of rules prohibiting the online prescription of mifepristone and its distribution through the mail.
Pro-life advocates have long raised the alarm that – in addition to their intended lethality for the unborn – the ready availability of abortion drugs poses serious risks of adverse events, puts women at increased risk of coercion and forced abortion, and undercuts state laws protecting unborn lives.
Numerous pro-life states, including Louisiana, have filed lawsuits against the FDA seeking a restoration of regulations on mifepristone or even a full rollback of FDA approval. In May of this year, a federal appellate court issued a unanimous ruling in favor of Louisiana in its litigation seeking to bring back the in-person dispensing requirement. The ruling would have blocked mail-order abortion nationwide, but the U.S. Supreme Court quickly issued an order granting emergency relief sought by drug manufacturers and permitting the ongoing distribution of dangerous abortion pills through the mail.
