The FDA now says the investigation will continue into next year.
The Food and Drug Administration extended the anticipated timeline of its safety review of abortion pills this week, much to pro-lifers’ dismay.
The FDA now says the investigation will continue into next year, according to an update filed in Louisiana federal court late Wednesday night.
The agency predicts it will receive results from the long-promised investigation by mid-December, but it believes the conclusions of its study will not be published until March. Included in Wednesday’s court-mandated update was confirmation the agency will not impose any new restrictions on the pill at this time.
“Following completion of its study and review, FDA will decide whether changes to the Mifepristone REMS Program are necessary and, if applicable, initiate any such changes in accordance with established processes,” according to court documents. “FDA anticipates that it will be able to provide an update to its estimated date of completion as more information becomes known, particularly in March 2027 when it expects to complete its report on the final study results.”
Pro-life groups are expressing frustration with the delayed timeline for the FDA’s review, arguing the agency must address potential safety risks after Health and Human Services Secretary Robert F. Kennedy Jr. and former FDA Commissioner Marty Makary committed to conducting a comprehensive review of the drug.
“Twenty months after first promising this review, administration officials continue to describe it as, in Secretary Kennedy’s words, ‘grounded in gold-standard science.’ FDA nominee Dr. Heidi Overton echoed that claim last week, testifying that the study is being conducted in ‘the most durable, scientific way possible,'” Susan B. Anthony Pro-Life President Marjorie Dannenfelser said in a statement.
“But instead of the promised gold-standard study, the FDA is trying to peddle fool’s gold. There is no indication that the agency has obtained commercially available data. And it remains unclear whether the FDA will even analyze crucial Medicaid data that reflect the 2023 changes to the abortion-drug regimen given Sentinel 2.0’s limitations.”
Similarly, Kristan Hawkins, president of Students for Life of America, said the court should not have to force the FDA to take action on the issue.
“It shouldn’t take a judge to pry some answers from the FDA on the dangers of chemical abortion pills, nor should it take this long to get them. While we are glad to see the FDA giving attention to deadly drugs, this is not enough to address the harms that recklessly approving mifepristone in 2000 did to public health and fertility,” Hawkins said in a statement.
Concern among pro-lifers over chemical abortion pills has only grown in recent years, after the Biden administration removed in-person dispensing requirements during the Covid-19 pandemic. In her statement, Dannenfelser cited a peer-reviewed article showing the Biden administration relied on insufficient evidence and flawed assumptions when it agreed to lift the in-person dispensing requirements.
Still, those safeguards have still not been reinstated. Countless reports have since been published detailing stories of women who have undergone coerced abortions, after their partners or family members have ordered the pills and either drugged or forced the women to induce an abortion.
The state of Louisiana is now suing the FDA over the in-person dispensing requirements, stating they undermine state pro-life laws. Earlier in the year, the Supreme Court blocked a 5th Circuit Court of Appeals decision that would have prohibited the nationwide distribution of the abortion drugs.
“This pill was designed to kill. Any review that does not acknowledge how this pill is being used today to empower abusers and enrich the new abortion cartel is completely inadequate,” Hawkins said. “And no report without environmental analysis is acceptable. Added to the death toll of chemical abortion pills are deadly risks to endangered species. Today’s status report is incomplete and insufficient.”
Mifepristone was first approved by the FDA in 2000. The drug, alongside Misoprostol, is used as part of a two-pill series to complete a chemical abortion.
The Ethics and Public Policy Institute published a report in April 2025 detailing the dangers of chemical abortion after analyzing “865,727 prescribed mifepristone abortions from 2017 to 2023.”
The report found almost 11 percent of women experience “sepsis, infection, hemorrhaging, or another serious adverse event” within 45 days of undergoing a chemical abortion. At the time, 22 attorneys general signed a letter urging the FDA to reinstate safeguards on the abortion pill.
A report from Senate Republicans at the end of August found that chemical abortion pill companies are routinely failing to comply with the FDA requirements that are currently in place, selling large quantities of the drugs to telemedicine companies that then do not ensure the rules are followed.
Detailed in the report, Dr. Christina Francis of the American Association of Pro-Life OBGYNs pretended to be a 13-year-old girl and found a provider to prescribe her the drugs, even though she expressed countless red flags, including that “she was 13 years old, had an intrauterine device in place (which leads to higher risk of having an ectopic pregnancy), had anemia (low blood count), took blood pressure medication, took blood thinning medication, had three caesarean sections (last one two years ago), and had an ectopic pregnancy one year ago.”
John Mize, CEO of Americans United for Life, said ahead of the FDA’s progress report that in the past year, since the promised study was announced, there has been no evidence of the review even beginning.
“The Pro-Life Movement is prepared to reject a methodologically flawed review where the agency has simply gone through the motions to rubber stamp the current REMS, or lack thereof,” Mize said in a statement.
Similarly, Dannenfelser expressed concern over the abortions that will continue to be carried out without immediate action from the FDA.
“Even under the FDA’s current timeline, the study will not be completed for at least another six months. Without action, that means 90,000 additional abortions in states whose strong protections for unborn children are being circumvented by the mail-order abortion-drug policy,” Dannenfelser said. “It also means more women left vulnerable to coercion and abuse because basic medical oversight is absent, denying women the healthcare they deserve and instead empowering abusers. Action is long overdue.”
The FDA did not immediately respond to National Review‘s request for comment.