Federal regulators will not complete a safety review of a widely used abortion pill until next year, the government said on Oct. 7.
Food and Drug Administration experts are reviewing the safety of mifepristone, the pill, including by conducting a study comparing outcomes in about 100,000 women who took the drug and 100,000 women who underwent surgical abortions, Department of Justice lawyers said in a court filing.
Officials said the study is expected to be completed by mid-December, but it will take time to review and evaluate the results and draft a report.
The process will be complete by spring 2027, if projections are correct.
The FDA is also running a statistical analysis of data from Sentinel, a project run by the FDA and partners such as Kaiser Permanente and the University of Florida College of Pharmacy, to gather more information about mifepristone’s safety.
Staffers are also poring over information submitted to the FDA in citizen petitions that cite more than 170 articles and publications, according to the filing.
After the work is complete, the FDA will decide whether to change how people access mifepristone.
Marjorie Dannenfelser, president of SBA Pro-Life America, said in a statement that the filing’s details were concerning, including a lack of indication that the FDA obtained data from companies.
“The administration must correct course—and, more importantly, it must not wait for the study to conclude before acting. Peer-reviewed evidence shows that the Biden administration relied on insufficient evidence and flawed assumptions when it removed the in-person dispensing requirement,” Dannenfelser said in a statement.
“The Trump administration must restore the vital safeguard of in-person dispensing immediately by settling the federal government’s litigation against Louisiana.”
The FDA did not return a request for comment by the time of publication.
The Supreme Court in 2022 overturned its 1973 ruling in Roe v. Wade, holding that the Constitution does not confer a right to abortion. The FDA in 2023 removed a requirement that mifepristone be dispensed in person.
Louisiana sued the FDA over the change, arguing it was illegal because it rests on an unsupported determination that mifepristone is safe.
A federal judge overseeing the case said in April that the FDA loosened restrictions despite a “dearth of information” but declined to block the change, concluding that courts must defer to the government on such matters, and noting the ongoing safety review.
The judge directed the FDA to file a status report within six months.
An appeals court panel in May, in response to an appeal from Louisiana to the April ruling, temporarily blocked access to mifepristone via mail until a final decision came on the appeal because “FDA conceded it had failed to adequately study whether remotely prescribing mifepristone is safe.”
The Supreme Court shortly after stayed the appeals court decision. The stay was later extended to remain in place until the appeals court comes to a final decision.
Dr. Heidi Overton, the nominee to head the FDA, said during her September confirmation hearing that she would not prejudge the ongoing safety review.