FDA Says Its Abortion Pill Safety Review Will Continue Into Next Year
The FDA says its safety review of mifepristone will continue into next year, with a final report expected by March 2027. The review was prompted by a court order and is part of an ongoing agency process. No final decisions have been made. A state lawsuit alleges mail delivery undermines abortion bans. Critics have made allegations about the administration's stance, but no official assessment has been issued.
Graphic: FDA says its abortion pill safety review will continue into next year · Graphic: Newyorkmatrix
Key points
The FDA's safety review of mifepristone will continue into next year.
The FDA provided a court-ordered update in a legal filing late Wednesday.
Mifepristone was first approved by the FDA in 2000.
The FDA has repeatedly affirmed the pill’s safety and effectiveness and has reduced restrictions, including eliminating the requirement for in-person dispensing.
A safety study is expected to be completed by mid-December 2026, with a report on findings expected no later than March 2027.
No final decisions have been made about new restrictions or changes to the drug’s use.
The FDA’s update was required by a federal judge in a case brought by the state of Louisiana, which alleged that mail delivery of mifepristone undermines its abortion ban.
A three-judge panel issued a ruling in a related case last month.
An allegation has been made by Gavin Oxley of Americans United for Life that the administration is out of step with women's health needs, but this has not been verified by official sources.
The FDA confirms that its evaluation of the primary abortion medication will extend beyond this year.
In a Wednesday legal document, the FDA provided a mandated update on its review progress. The review was initiated by the agency and is part of a reevaluation ordered by the FDA.
The FDA first authorized mifepristone in the year 2000. The agency has consistently validated the pill’s safety and performance throughout the years. Several limits on the drug have been lifted, such as removing the need for in-person pickup.
The FDA expects to complete a safety study by mid-December 2026. Officials anticipate releasing a report by March 2027 at the latest.
No final decisions have been made about new restrictions or changes to the drug’s use.
A federal judge ordered the FDA’s change after Louisiana sued, claiming mail-based mifepristone use weakens its abortion law.
This case is one of several state lawsuits related to mifepristone currently in court. Last month, a three-judge panel issued a ruling in a related case.
An official statement from the FDA does not include any assessment of the administration’s stance on the pill or its impact on women's health.
Gavin Oxley of Americans United for Life criticized the review, calling it a lack of 'true leadership' by Trump administration officials. He claimed the administration remains out of step with women's health needs and shows no intent to reduce the persistent damage from the abortion pill.
This claim is an allegation and has not been verified by the FDA or any official body.
In the United States, abortion most frequently uses the combination of mifepristone and misoprostol.
The review is ongoing and no final decisions have been made.
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