FDA Delays Review of Abortion Pill, Leaving Women Unprotected
The Food and Drug Administration (FDA) won’t complete its safety review of the dangerous abortion pill until later this year, and won’t release results until March 2027, a new filing from the Justice Department revealed.
The U.S. Court of Appeals for the 5th Circuit ordered the FDA to file an update on its ongoing review of mifepristone by October 7.
Mifepristone is the first drug in a two-drug abortion regimen commonly referred to as the abortion pill.
The court-ordered update comes in the case of Louisiana v. FDA, where the state of Louisiana and Alliance Defending Freedom are suing the FDA over its relaxing of the in-person dispensing requirement, a regulation that had been on the books since 2000. The requirement mandated women obtain the abortion pill in person because of its serious safety concerns.
In 2023, when the Biden FDA removed the requirement from its Risk Evaluation and Mitigation Strategy (REMS) for the drug, it allowed mifepristone to be sent through the mail and administered without medical oversight. The change permitted doctors in pro-abortion states to mail mifepristone to individuals in pro-life states, effectively nullifying those states’ laws restricting abortion.
It also opened the door to abuse of the abortion pill, as occurred in the case of Rosalie Markezich, who was forced by her violent boyfriend to take abortion drugs after he obtained them online from a doctor in California and had them mailed to Louisiana. Markezich is a party to Louisiana’s lawsuit.
In its filing to the court, the FDA disclosed it “is on track to obtain study results by mid-December 2026. FDA will then need to review and evaluate/interpret the results and draft a report. FDA expects to complete that process not later than March 2027.”
The FDA’s study of mifepristone’s safety, which the agency initially launched in 2025, was reportedly set to conclude in September. That has now been pushed back several months.
Multiple pro-life leaders criticized the delay.
Alliance Defending Freedom official counsel Erin Hawley said the FDA has “failed to deliver” the study that it “has promised for nearly two years.”
“Nearly 90,000 unborn babies … will die between now and [March] by illegally obtained abortion drugs in states like Louisiana that have taken great care to protect babies and mothers from the harms of abortion,” Hawley warned.
“Every month of additional delay puts nearly 15,000 additional babies at risk in states where mail-order abortion drugs are unlawful – 1,000 in Louisiana alone.”
Lila Rose, founder and president of Liva Action, called the delay unacceptable.
“Every day, women are put at risk and preborn children are killed,” Rose said. “The FDA must pull the abortion pill from the market NOW.”
Susan B. Anthony Pro-Life American President Marjorie Dannenfelser said the agency’s move “should concern every American who cares about unborn babies and women’s safety.”
“Twenty months in, we’re still not seeing the gold-standard study that was promised,” she said. “The Trump administration must act by settling the case with Louisiana and ending mail-order abortion.”
Liberty Counsel Founder and Chairman Mat Staver said, “The FDA’s deregulatory actions regarding abortion drugs allow innocent children to be destroyed and women to be harmed. … The FDA needs to reinstate safety measures for abortion pills now!”
The update comes just a couple weeks after a coalition of 50 leading pro-life groups urged Dr. Heidi Overton, nominee for FDA commissioner, to commit to restoring safeguards on the abortion pill should she be confirmed by the U.S. Senate.
Dr. Overton, who is widely seen as friendly to the pro-life movement, said she couldn’t make a categorical commitment that would “prejudge the determination of the safety review that’s currently ongoing.”
The Ethics and Public Policy Center (EPPC) released a study last year finding nearly 11% of all women who abort their children with mifepristone suffer from serious health complications, including sepsis, infection or hemorrhaging, sparking the FDA’s investigation.
While it’s unclear what the results of the FDA’s study will show, what’s perfectly clear is that thousands of women are being harmed from the abortion pill, and millions of preborn babies’ lives are being lost.
The FDA should act as soon as possible to reinstate safeguards on the abortion pill and reinstate the in-person dispensing requirement. Vulnerable women and preborn babies would be safer for it.
If you are experiencing an unexpected pregnancy and want to learn more about your options, you can visit My Choice Network.
Please considering supporting Focus on the Family’s Option Ultrasound program to place ultrasounds in pregnancy centers around the country. To date, we’ve helped save over 500,000 preborn babies from abortion.
Related articles and resources:
Dealing With Unplanned Pregnancy
Become an Option Ultrasound Life Advocate
How You Can Join the Pro-Life Movement
How To Join The Pro-Life Movement
Scriptures Advocating For The Pre-Born
The History of Christianity and Abortion
Pro-Life Groups Urge FDA to Restore Abortion Pill Safeguards
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