FDA Extends Review of Abortion Pill Mifepristone into 2027

The Food and Drug Administration (FDA) has announced that its ongoing safety review of mifepristone, the nation's primary abortion pill, will extend into next year. This timeline was disclosed in a court-ordered legal filing late Wednesday.

The reevaluation, ordered by Health Secretary Robert F. Kennedy Jr., is expected to conclude a safety study by mid-December of this year. However, a comprehensive report on the findings is not anticipated until "no later than March 2027." Following this report, the FDA will determine whether to implement new restrictions or other modifications to the drug's use.

Mifepristone was initially approved by the FDA in 2000. Over the years, the agency has consistently affirmed the pill's safety and effectiveness, and has also eased several dispensing requirements, including removing the mandate for in-person distribution. Despite these affirmations, anti-abortion groups and their congressional allies have pressed the administration to revisit the pill's status since President Donald Trump's return to the White House, aiming to limit its availability.

Abortion opponents have voiced strong disapproval of the extended review timeline. Gavin Oxley of Americans United for Life criticized the decision, stating it reflects a lack of "true leadership" from Trump administration officials and that "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."

The two-drug regimen, comprising mifepristone and misoprostol, is currently the most common method for abortions in the United States. The FDA's obligation to provide this update stems from a federal appeals court in New Orleans, which is presiding over a lawsuit filed by the state of Louisiana. The lawsuit alleges that the mail delivery of mifepristone contravenes the state's abortion ban. This case is one of several state-level legal challenges concerning mifepristone that are progressing through the court system.