FDA says mifepristone safety review will not be finished until March 2027
In short
The US Food and Drug Administration said in a court filing on Wednesday that it expects safety study results on the abortion pill mifepristone by mid-December and a final report no later than March 2027. The agency will then decide whether to impose new restrictions or other changes on the drug's use. Anti-abortion and abortion rights groups both criticised the timeline.
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The US Food and Drug Administration expects to complete its safety review of the abortion pill mifepristone in March, according to a court document the Justice Department filed Wednesday, NBC News reported. In the filing, the agency said it is on track to obtain study results by mid-December and expects to complete a report on the final results "no later than March 2027," after which it will decide whether to impose new restrictions or other changes on the drug's use. The Hill reported that the agency said it would not impose any new restrictions on the pill before that point. [ 1 , 2 , 3 ]
According to NBC News, the FDA said it plans to compare mifepristone's safety to that of surgical abortions through 10 weeks' gestation and will measure the frequency of side effects among roughly 100,000 women who took the drug. The agency said it plans to re-evaluate its 2023 decision to end in-person dispensing based on the new data and may weigh the views of patients, providers and pharmacists. The Hill reported that the FDA is separately reviewing the drug's Risk Evaluation and Mitigation Strategy program, a process that could take much longer because the agency said it must review hundreds of citations in citizen petitions. "Following completion of its study and review, FDA will decide whether changes to the Mifepristone REMS Program are necessary," the agency wrote. [ 1 , 2 ]
The timeline drew criticism from both sides. Gavin Oxley of the anti-abortion group Americans United for Life said the administration "continues to find itself on the wrong side of women's health," the Associated Press reported. Abortion rights groups called the review a political stunt and said the administration is deliberately delaying it until after November's midterm elections, according to The Hill, which quoted Reproductive Freedom for All President and CEO Mini Timmaraju calling it "an unnecessary political stunt." NBC News noted the expected completion date falls months after the Nov. 3 midterms. [ 1 , 2 , 3 ]
The update was ordered in a case brought by Louisiana alleging that mail delivery of mifepristone undermines the state's abortion ban. NBC News and the AP said the order came from a federal judge, while the ABC News version of the AP story said it came from a federal appeals court in New Orleans. NBC News reported that Louisiana filed the case on behalf of a woman who said her boyfriend ordered abortion pills and forced her to take them, and that in May an appeals court reinstated a nationwide in-person dispensing requirement before the Supreme Court blocked that decision while the case continues. [ 1 , 3 , 5 ]
The FDA approved mifepristone in 2000, and NBC News reported that hundreds of peer-reviewed studies have found it safe and effective. The agency temporarily eliminated the in-person dispensing requirement in 2021 and finalized the change in 2023. Combined with misoprostol, mifepristone forms the most common method of abortion in the US, the AP reported. [ 1 , 3 ]
Why it matters
The timeline means any FDA decision on new limits for the most common abortion method in the US will come months after the Nov. 3 midterm elections, NBC News noted. The review also bears on a Louisiana lawsuit challenging telehealth prescribing of the pill, which NBC News said has largely preserved nationwide access to abortion since Roe v. Wade was overturned.
Key facts
- The FDA expects to obtain results of its mifepristone safety study by mid-December. [ 1 , 2 , 3 ]
- The agency expects to complete its report on the final study results no later than March 2027. [ 2 , 3 ]
- The update was given in a court-ordered filing in a case brought by the state of Louisiana. [ 1 , 2 , 3 ]
- The FDA plans to compare mifepristone's safety with surgical abortions through 10 weeks' gestation, measuring side effects among roughly 100,000 women, NBC News reported. [ 1 ]
- The FDA said it plans to re-evaluate its 2023 decision to drop the in-person dispensing requirement based on the new data. [ 1 ]
- The agency is separately reviewing the mifepristone Risk Evaluation and Mitigation Strategy (REMS) program, a process The Hill reported could take much longer. [ 2 ]
- The safety review was ordered by Health Secretary Robert F. Kennedy Jr. [ 1 , 3 ]
Confirmed by several sources
- The FDA expects mifepristone safety study results by mid-December. [ 1 , 2 , 3 ]
- The FDA expects to finish its report on the review in March 2027. [ 1 , 2 , 3 ]
- The update came in a court filing in a lawsuit brought by Louisiana. [ 1 , 2 , 3 ]
- The FDA approved mifepristone in 2000. [ 1 , 3 ]
- Health Secretary Robert F. Kennedy Jr. ordered the safety review. [ 1 , 3 ]
Still unclear
- Which court ordered the FDA's progress update. NBC News and most AP copies say a federal judge in Louisiana; the ABC News version of the AP story says a federal appeals court in New Orleans.
- Whether the FDA will impose any new restrictions before March. Only The Hill reports the agency said it would not impose new restrictions before then.
- How long the separate review of the REMS safety program will take. The Hill reports it could take much longer than the safety study; no completion date is given.
- Whether the timing was chosen to fall after the midterm elections. Abortion rights groups say the release is being deliberately delayed; the documents carry no administration response to that claim.
What local media are saying
Timeline, local time
- NBC News reports the FDA expects to complete its mifepristone safety review in March. [ 1 ]
- The Hill reports the agency's five-page update and criticism from abortion rights groups. [ 2 ]
- The Associated Press reports the review will continue into next year and that anti-abortion groups condemned the timeline. [ 3 ]