Leading medical groups call on the FDA to reinstate safety measures and review new data on abortion pill risks.

Medical Organizations Call for FDA Reevaluation

Several major pro-life medical organizations are urging U.S. health officials to reconsider the Food and Drug Administration’s broad approval of the abortion drug mifepristone, citing new real-world data and reported adverse events. In a letter addressed to Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary, six medical groups—including the American Association of Pro-Life OBGYNs and the Alliance for Hippocratic Medicine—request the reinstatement of safety protocols that were removed from mifepristone’s use since its initial approval in 2000.

The letter references studies released in May, which analyzed the insurance records of 860,000 women who received mifepristone prescriptions. The findings, according to the groups, indicate that over 10% of these women experienced serious adverse events—such as hemorrhage, sepsis, or the need for surgical intervention—within 45 days of taking the drug. “The data strongly suggest that mifepristone poses a far greater risk of causing harm than previously stated,” the letter asserts, calling for a new FDA review of both adult and adolescent populations.

Concerns Over Deregulation and Patient Safety

Under the Biden administration, the FDA expanded access to mifepristone, allowing for prescriptions via telemedicine and mail delivery without mandatory in-person visits or ultrasounds. The medical groups argue this deregulation has led to a lower standard of care and increased risk for women and girls. They urge the FDA to restore prior safety requirements, including limiting the drug’s use to seven weeks of pregnancy, mandating in-person dispensing and follow-up appointments, and requiring ultrasounds to confirm gestational age. The groups also call for renewed reporting of all adverse events.

“A basic tenet of medical ethics is informed consent—which requires a review of accurate risks and benefits of any proposed intervention based on actual data, not ideology,” the letter states. The authors stress that women deserve full transparency about the risks associated with mifepristone, regardless of the political climate.

While Planned Parenthood maintains that chemical abortion is safe and the manufacturer of mifepristone, Danco, stands by the drug’s safety record, the pro-life groups dispute these claims. Recent legal battles, including a Supreme Court case in 2024, have kept the debate in the national spotlight, though the high court ultimately dismissed a challenge to the FDA’s approval on procedural grounds.

Ongoing Debate and Call for Action

The letter concludes by urging the FDA to rely on robust, real-world safety data and reinstate protections that, according to the medical groups, should never have been removed. Dr. Christina Francis, CEO of the American Association of Pro-Life OBGYNs, warned that the FDA’s current policy “subjects pregnant women to an unacceptably low standard of care, leaving them vulnerable to life-threatening complications, and empowers abusers and traffickers.”

The FDA’s regulatory approach to abortion drugs remains under intense legal, medical, and ethical scrutiny. As the debate continues, both supporters and critics of mifepristone’s broad approval are closely watching for any response from federal authorities.