FDA says mifepristone safety review will continue into 2027
The FDA says its safety review of mifepristone will continue into 2027, with a findings report due by March.
WASHINGTON — The Food and Drug Administration says its safety review of mifepristone, the abortion pill, will continue into 2027 — a timeline abortion opponents hoping to curb its use swiftly criticised.
The update came in a filing late Wednesday, the first substantive account of Health Secretary Robert F. Kennedy Jr.’s ordered reevaluation, the Associated Press reported.
A safety study should finish by mid-December, with findings due “no later than March 2027” — before the FDA decides whether to impose new restrictions or other changes.
The agency is using a “statistical data mining method” to find “unknown safety concerns” in a database of side-effect reports, and is weighing petitions on prescribing and distribution, CNN reported.
Mifepristone was approved in 2000 and the FDA has reaffirmed its safety and effectiveness, with in-person dispensing eased. With misoprostol, it is America’s most common form of abortion.
Gavin Oxley of Americans United for Life called it a lack of “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.
The update was ordered by a federal judge in a Louisiana case alleging mail delivery of mifepristone undermines the ban. A 5th Circuit panel questioned the case’s merits and standing last month, though the Supreme Court has blocked changes until it reviews the case.
Opponents have focused on a 2021 decision allowing online prescribing and mail delivery, made permanent under President Joe Biden in 2023.
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