Robin Marty / CC BY 2.0
CV NEWS FEED // A coalition of pro-life organizations is urging the Food and Drug Administration (FDA) and the Department of Justice (DOJ) to take basic steps toward protecting women and girls from chemical abortion drugs, which not only are almost always deadly for unborn children but also may lead to the death of the mother.
Americans United for Life (AUL) is spearheading the efforts. In its Jan. 22 letter to the FDA Commissioner, the coalition said the FDA should reinstate the Risk Evaluation and Mitigation Strategy (REMS). According to the American Association of Obstetricians and Gynecologists, in part the REMS originally required an in-person dispensing of the chemical abortion drug, as opposed to by mail or at a retail pharmacy.
“The FDA’s recent and ongoing actions to loosen safeguards on abortion drugs, including the removal of key REMS, represent a grave threat to women’s health and the lives of preborn children,” the coalition stated. “These decisions contradict the agency’s duty to protect public health and prioritize safety.”
They noted that in 2021, the FDA approved the dispensing of chemical abortion drugs by mail without requiring a medical evaluation. In 2023, the FDA began allowing retail pharmacies to carry and dispense the drugs.
“These pills pose significant, well-documented risks to women. The physical dangers include septic infection, hemorrhage, and death,” the coalition wrote. “Especially when used without proper medical oversight, such as in the absence of an ultrasound to rule out ectopic pregnancy, the risks become life-threatening.”
>> Women who use chemical abortion pills significantly more likely to end up in emergency room <<
The coalition — which includes leaders from Live Action, the James Wilson Institute, Heartbeat International, AAPLOG, and Thomas More Society, among many others — urged the FDA to rescind these measures.
The group also urged the DOJ to enforce the Comstock Act’s anti-abortion trafficking laws. In the Jan. 22 letter to DOJ Acting Attorney General James McHenry, the coalition detailed how the Comstock Act prohibits mailing abortifacients through the U.S. Postal Service and various other services. Despite this, distribution of chemical abortion drugs by mail has increased in recent years.
Similar to the concerns outlined in the FDA letter, the coalition noted that women who receive the drugs by mail often do not receive an ultrasound, which is the most accurate way to determine gestational age. Without one, a woman may attempt a chemical abortion past 10 weeks of pregnancy, which increases risks and rates of severe complications and even death, they continued.
“Blatant violations of the federal Act expose women to dangerous and unsafe drugs and undermine the integrity of the medical profession,” they wrote. “We ask that the DOJ prioritize investigations and enforcement against those who are involved in the illegal distribution of abortion pills. The health and safety of women must be a priority, and the DOJ’s enforcement of these laws will help to safeguard patient safety.”
They urged for the DOJ to immediately work to “ensure that the distribution of abortion pills does not continue harming mothers, unborn children, and families across America.”
A list of principals and organizations who signed the letters can be accessed here.
The FDA has faced legal pressure before over its loosening of chemical abortion drug regulations. In 2024, the FDA’s actions were the subject of a lawsuit that escalated up to the United States Supreme Court. In June 2024, the Court unanimously ruled that the plaintiff Alliance for Hippocratic Medicine, which had sued the FDA, did not have the proper standing to challenge the FDA in court. Justice Brett Kavanaugh wrote in the ruling that the plaintiffs’ concerns needed to be brought up through a different avenue, such as in a legislative or regulatory process.
