Last week, the Food and Drug Administration (FDA) provided a court-ordered update on the status of the agency’s long-awaited safety review of the abortion drug mifepristone. The study officially began in September 2025 with a completion date set for the end of 2026—but on October 7, the agency reported that the study would be published in March 2027 instead.
The ongoing safety review of the abortion drug mifepristone follows over two decades of conflict over the drug at the FDA. The FDA approved Mifeprex (mifepristone) for use in abortions in 2000. Since then, the FDA has abandoned common-sense safety and responsibility standards for regulating the drug.
FDA guidance originally included stringent safety standards for the use and prescription of Mifeprex: a minimum of three in-person consultations with a doctor, a maximum gestational age of seven weeks, in-office dispensation and consumption, mandatory in-office follow-ups, and mandatory reporting of adverse events. None of these standards remain—Biden’s FDA hacked away at the last of the FDA’s commonsense requirements, and Mifeprex is now available via mail to the general public without a doctor’s advice or notice.
To make matters worse, former FDA Commissioner Marty Makary issued an approval of Evita Solutions’ generic abortion drug on September 30, 2025—the same month the safety review began. Concerned Women for America (CWA) CEO and President Penny Nance immediately criticized the agency: “Our government should be rejecting drugs that kill unborn children and put women’s lives at risk, not approving them. We hope the FDA will reconsider its approval.”
While proponents of the abortion drug claim that it is “safer than Tylenol,” science suggests otherwise—any drug with the stated purpose of killing an unborn baby is fundamentally unsafe. Besides always killing a child, the chemical abortion drug is proven to be a threat to women’s health and safety, too: 11% of women experience a serious adverse medical event—like severe hemorrhaging or sepsis—after taking Mifeprex for a DIY abortion. Drug-induced abortions are the riskiest kind, with a complication rate four times higher than surgical abortions. Women aren’t being informed of these risks, and many face these complications alone in their bathrooms without any medical supervision.
Biden’s mail-order abortion scheme has been both disastrous for women and a dream for domestic abusers. First, without an in-person ultrasound and adequate screening to rule out ectopic pregnancy and confirm gestational age, the abortion drug can be fatal. Second, since 2001, there have been 29 publicly recorded instances of abortion drug poisoning by male abusers resulting in death or significant injury.
Those incidents are likely a small representation of a larger number, however. Many women likely do not report coercion or abuse, and the abortion drug mifepristone is available to human trafficking networks by mail. In addition, beginning in 2016 during the first major change to the original approval, the FDA eliminated the requirement for prescribers to report all non-fatal serious adverse events.
With a pressing crisis at hand—the abortion drug is responsible for nearly three quarters of abortions—pro-life lawmakers are raising concerns with the FDA about the integrity and slow pace of the agency’s review. From the United States Senate, Senator Josh Hawley (R-Missouri) sent a letter to acting FDA Commissioner Kyle Diamantas requesting information on the data the agency is using for its study. Considering former Democrat administrations’ intentional coverup of adverse side effects from the abortion drug, using data that reflects real-world conditions is key to the study’s integrity.
From the House of Representatives, Congressman Chip Roy (R-Texas 21st) sent a letter pressing the FDA for its slow pace conducting “an open-ended review while continuing to administer the Biden Administration’s policy,” adding that, “Every day FDA delays action is another day this dangerous regulatory regime remains in place, allowing more abortion pills to be distributed by mail and more unborn children to lose their lives.”
The FDA’s delay has a human cost—an estimated 90,000 babies will be killed by the abortion drug between now and March 2027, and an untold number of women may be abused, coerced, or poisoned by it. Please join Concerned Women for America in praying that the FDA would renew its commitment to a thorough, timely, quality review of the abortion drug mifepristone; that the agency would realize the severity of the harms the drug does to women and unborn babies; and that come March 2027, the truth about the deadly abortion drug will be exposed.
