FDA Extends Mifepristone Safety Review Into 2027
The FDA said its safety review of mifepristone will continue into next year, with a study expected by mid-December and a report no later than March 2027. The agency is also considering petitions that could change how the abortion pill is prescribed and distributed. Anti-abortion groups criticized the timeline, while the review follows a request from Health Secretary Robert F. Kennedy Jr.
Mifepristone has been approved in the U.S. since 2000. Over the years, the FDA has repeatedly affirmed its safety and effectiveness while relaxing restrictions, including the in-person dispensing requirement.
The current review follows a request from Health Secretary Robert F. Kennedy Jr. and a Louisiana lawsuit challenging mail delivery. The agency told a court it expects a safety study by mid-December and a report by March 2027 at the latest. It is also considering petitions that could change prescribing and distribution.
The timing may prolong uncertainty for patients, clinicians, pharmacies, and state regulators, since mifepristone remains central to medication abortion. If the review leads to new restrictions, access could narrow, especially in states with bans or telehealth limits; if it does not, existing mail and telehealth pathways may continue. Anti-abortion groups and abortion-rights advocates are likely to keep pressing courts and agencies, so the dispute may shape care and legal risk beyond the pill itself.