Pro-life groups urge Kennedy, FDA to reinstate abortion safeguards removed under Biden

Pro-life medical groups are calling on Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary to reexamine the FDA’s broad approval of abortion drugs, specifically the abortion pill mifepristone. This comes as Planned Parenthood sues the Trump administration over provisions in the Big, Beautiful Bill that defund abortion providers.
In a letter obtained by Fox News Digital, six anti-abortion medical organizations, representing around 30,000 medical professionals, are urging Kennedy and Makary to reinstate safety measures on mifepristone that were removed since its approval in 2000. The FDA has recently expanded its approval of mifepristone under the Biden administration, allowing for telemedicine consultations and mail-order prescriptions.
Medication abortion, which involves mifepristone and misoprostol, accounts for 63% of all U.S. abortions. However, the groups argue that mifepristone poses serious risks to women, including sepsis, infection, hemorrhaging, and incomplete abortions requiring surgical intervention. Recent reports suggest that as many as one in nine women using mifepristone experience serious adverse events.
The letter calls for the FDA to conduct its own evaluation of real-world data on mifepristone’s safety and to reinstate reporting of all adverse events related to the drug. The groups also urge the FDA to reinstate pre-2016 Risk Evaluation and Mitigation Strategies, including limiting the drug’s use to 7 weeks of gestation and requiring in-person dispensing and follow-up appointments.
The letter emphasizes the importance of requiring ultrasounds to confirm the gestational age of the fetus, ensuring that women have accurate information about the risks and benefits of using mifepristone. The groups argue that women deserve to know the true risk of serious adverse events associated with the drug, and that the FDA should prioritize safety standards.
The FDA’s approval of mifepristone has been a subject of legal debate, with the Supreme Court dismissing a case challenging the drug’s approval in 2024. Despite claims that mifepristone has a safety profile comparable to ibuprofen, recent reports and studies have raised concerns about the drug’s safety and efficacy.
In response to the letter, Dr. Christina Francis, CEO of the American Association of Pro-Life OBGYNs, stated that the FDA’s deregulation of mifepristone puts pregnant women at risk of life-threatening complications and empowers abusers and traffickers. The groups are urging the FDA to prioritize women’s safety and reexamine the drug’s approval.
The other organizations that signed onto the letter include the Christian Medical and Dental Association, the American College of Pediatricians, and the Coptic Medical Association of North America. The call to reexamine the safety of mifepristone highlights the ongoing debate over abortion drugs and the need for rigorous safety standards in medical care.