The Food and Drug Administration says its continuing safety review of the nation’s main abortion pill will extend into next year, a timetable that quickly drew condemnation from abortion opponents seeking tighter limits on the drug.

The agency disclosed its schedule in a legal filing late Wednesday after a court ordered it to provide an update. The filing offered the first substantive details about the controversial reevaluation ordered by Health Secretary Robert F. Kennedy Jr.

Mifepristone was first approved by the FDA in 2000. Since then, the agency has repeatedly reaffirmed the medication’s safety and effectiveness while easing several restrictions governing how patients can obtain it.

Among those changes, the FDA eliminated a requirement that mifepristone be dispensed in person. That shift has become a central focus for groups pressing the Trump administration to reconsider how the pill is prescribed and distributed.

Since President Donald Trump returned to the White House, abortion opponents and their allies in Congress have urged the administration to revisit the medication. Their efforts are aimed at securing new restrictions on its use.

According to the filing, the FDA expects to complete its safety study by mid December this year. A report detailing its findings is expected “no later than March 2027.”

Once the report is completed, the agency will decide whether to impose new restrictions or make other changes affecting use of the drug. The filing did not announce any immediate change to access.

Gavin Oxley of Americans United for Life, an abortion opposition group, criticized the timetable. He described the administration’s approach as lacking “true leadership.”

“The administration continues to find itself on the wrong side of women’s health, clearly uninterested in mitigating the ongoing harms caused by the abortion pill,” Oxley said.

Mifepristone is used in combination with a second drug, misoprostol. Together, the medications constitute the most common form of abortion in the United States.

The FDA provided its latest update at the direction of a federal judge in a case filed by Louisiana. The state alleges that delivery of mifepristone through the mail undermines its abortion ban.

The Louisiana dispute is one of several state lawsuits involving mifepristone that are moving through the courts. Last month, a three judge panel of the 5th U.S. Circuit Court of Appeals questioned the merits of Louisiana’s case.

The panel’s questions included whether Louisiana has the legal standing required to challenge the FDA’s oversight of mifepristone. Any decision from the appeals court would not immediately alter access to the medication.

The Supreme Court has blocked changes to the drug until the case comes before it again. As a result, the current legal landscape would remain in place despite a ruling from the 5th Circuit in the Louisiana litigation.

The FDA said Wednesday that it is applying a “statistical data mining method” as it looks for previously unknown safety concerns that may be associated with the medication.

The information being examined comes from an electronic database. That database collects reports involving medical injuries and drug side effects from major health networks and insurers.

Beyond the safety study, the FDA said it is reviewing multiple petitions seeking changes to the way mifepristone is prescribed and distributed. The agency did not announce decisions on those petitions in the filing.

Abortion opponents have concentrated much of their effort on a 2021 decision that allowed doctors to prescribe mifepristone online and send it through the mail during COVID-19.

That policy became permanent under President Joe Biden in 2023. The change had the effect of undermining several state abortion bans because women could receive the medication through the mail.

For now, the review, the pending petitions and the continuing court fights leave the future rules surrounding mifepristone unresolved. The FDA’s stated schedule places its report in 2027, after completion of the safety study expected this year.