FDA's Abortion Pill Safety Review Will Run Into 2027, Angering Abortion Opponents
The agency told a federal court it expects to finish its mifepristone study by mid-December and report no later than March 2027, before deciding on any new restrictions.
The Food and Drug Administration's safety review of the abortion pill mifepristone will continue into next year, the agency said in a court filing late Wednesday, a timeline that abortion opponents who hoped to see the drug's use curtailed quickly condemned.
The filing was a court-ordered progress report and the first substantive information the agency has released about the reevaluation that Health Secretary Robert F. Kennedy Jr. ordered. The FDA said it expects to finish a safety study of the pill by mid-December this year. A report on the findings is expected "no later than March 2027," after which the agency will decide whether to impose new restrictions or other changes on how the drug is used.
Gavin Oxley of Americans United for Life, an anti-abortion group, criticized the schedule as a lack of "true leadership" by Trump administration officials. "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," he said.
The FDA first approved mifepristone in 2000. Over the years the agency has repeatedly reaffirmed that the drug is safe and effective and has eased several restrictions, including dropping a requirement that it be dispensed in person. Since President Trump returned to the White House, anti-abortion groups and their allies in Congress have pushed the administration to revisit the pill. Mifepristone, taken with a second drug called misoprostol, is the most common form of abortion in the United States.
The FDA said it is using a "statistical data mining method" to look for "unknown safety concerns" with the drug. The data come from an electronic database that collects reports of medical injuries and drug side effects from major health networks and insurers. The agency also said it is considering a number of petitions that propose changes to how mifepristone is prescribed and distributed.
Abortion opponents have focused most of their effort on a 2021 decision that allowed doctors to prescribe the drug online and send it by mail during the COVID-19 pandemic. President Joe Biden's administration made that change permanent in 2023. It undercut a number of state abortion bans, because women can receive the pills by mail.
A federal judge ordered the update in a case brought by the state of Louisiana, which alleges that mail delivery of mifepristone is unlawful. It is one of several state lawsuits over the drug moving through the courts. Last month, a three-judge panel of the 5th U.S. Circuit Court of Appeals questioned the merits of Louisiana's case, including whether the state has legal standing to challenge the FDA's oversight of the drug. Any 5th Circuit ruling would not immediately change the landscape, because the Supreme Court has blocked changes to the drug's availability until it sees the case again.
Legal experts have said that withdrawing approval outright would be an extraordinary step that would draw immediate challenges. CBS News medical correspondent Dr. Celine Gounder said in 2025 that, depending on what the review finds, the FDA could instead make access harder by limiting telehealth or mail prescribing, or by restricting who may prescribe the drug to doctors rather than physician assistants or nurses.
