The FDA says its ongoing safety review of mifepristone, the nation's main abortion pill, will continue into next year. In a court-ordered legal filing, the agency said it expects to complete a safety study by mid-December 2026 and issue a report no later than March 2027, after which it will decide whether to impose new restrictions. The reevaluation was ordered by Health Secretary Robert F. Kennedy Jr., and the filing provides the first substantive update on that process.
The agency has repeatedly reaffirmed the pill's safety and effectiveness since its 2000 approval. For the current review, the FDA said it is using a "statistical data mining method" to uncover "unknown safety concerns" from an electronic database of medical injury and side-effect reports. It is also considering petitions that propose changes to how mifepristone is prescribed and distributed, including a 2021 decision that allowed online prescribing and mail delivery.
Abortion opponents quickly condemned the timeline. Gavin Oxley of Americans United for Life accused the administration of lacking "true leadership" and being "clearly uninterested in mitigating the ongoing harms caused by the abortion pill." The review stems from a Louisiana lawsuit challenging mail delivery of the drug; a 5th Circuit panel recently questioned the state's standing, and the Supreme Court has blocked any changes to mifepristone until it considers the case again. The two sources, both carrying the same Associated Press report, agree on all details.