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FIRST ON FOX: As Planned Parenthood takes legal action against the Trump administration regarding the defunding of abortion providers, pro-life medical organizations are reaching out to Health and Human Services Secretary Robert F. Kennedy Jr. They are requesting a thorough reexamination of the FDA’s broad approval of abortion drugs.
In a letter acquired by Fox News Digital, six anti-abortion medical organizations, representing around 30,000 healthcare professionals, urge both Kennedy and FDA Commissioner Martin Makary to restore safety measures on mifepristone. These safeguards have been removed since its initial approval in 2000.
The Guttmacher Institute reports that medication abortions currently account for 63% of all abortions performed in the United States. The standard medication abortion procedure includes taking mifepristone, a drug that blocks progesterone, effectively starving the fetus of essential nutrients. A second medication, misoprostol, is then administered to expel the deceased fetus.
Under the Biden administration, the FDA has dramatically broadened access to mifepristone. This change allows women to receive the drug via telemedicine without needing in-person doctor visits, and it enables these prescriptions to be mailed directly to patients.
In their correspondence, the medical groups—which include the American Association of Pro-Life OBGYNs, the Alliance for Hippocratic Medicine, and the American College of Family Medicine—express grave concerns. They cite data indicating that hundreds of thousands of women may have experienced harmful effects from using mifepristone.
Planned Parenthood claims on its website that chemical abortions are safer than many commonly used medications such as penicillin, Tylenol, and Viagra. Conversely, the letter characterizes mifepristone as a high-risk abortion-inducing medication associated with severe health risks and emergencies, citing issues like hemorrhage, sepsis, and incomplete abortions that necessitate surgical intervention.
The letter references two reports published in May: one from the Foundation for the Restoration of America and another from the Ethics and Public Policy Center. According to these reports, approximately one in nine women using mifepristone has experienced serious adverse events.
The analyzed health data encompassed 330 million U.S. patients and involved 860,000 women who received mifepristone prescriptions. The report indicates 10.93% of these women encountered complications such as sepsis, infections, severe bleeding, or required surgical interventions within 45 days of using the drug.
Based on these findings, the letter insists that real-world data regarding mifepristone use indicates that patients frequently experience serious medical emergencies, aligning with observations from healthcare professionals in their clinical settings.
The groups assert that data suggests mifepristone may pose a significantly greater risk than previously acknowledged, with the potential for severe complications being 22 times higher than what has been disclosed to the public.
Given these concerns, AAPLOG and collaborating organizations are urging the FDA to independently assess existing real-world data to evaluate mifepristone’s overall safety for both adults and adolescents. They emphasize the necessity of reinstating comprehensive reporting of all adverse events connected to mifepristone usage and bringing back the pre-2016 Risk Evaluation and Mitigation Strategies. This includes limiting the drug’s use to seven weeks of pregnancy and requiring in-person dispensing and follow-up visits.
The letter highlights the importance of conducting ultrasounds to confirm gestational age. This step, the groups argue, is vital for accurately assessing pregnancy duration and identifying possible complications.
Medical ethics emphasize the paramount importance of informed consent. The letter asserts that patients deserve access to accurate risk assessments and benefits associated with any medical procedure informed by data rather than politically motivated narratives. Women must be aware of the genuine risks of serious complications and medical emergencies stemming from mifepristone usage regardless of the heated political discourse surrounding the drug.
The letter also emphasizes the trust the public must have in the FDA’s ability to uphold rigorous safety standards before and after any drug’s approval. Americans should be assured that they can provide truly informed consent, understanding the risks associated with taking FDA-approved medications.
Over recent years, the FDA’s broad approval of mifepristone has ignited considerable legal disputes, even reaching the Supreme Court. In 2024, the Court dismissed a challenge from the Alliance for Hippocratic Medicine regarding the FDA’s approval of the abortion pill, primarily on the basis of standing.
During that period, Dr. Jack Resneck Jr., the then-president of the American Medical Association, warned against the consequences of restricting mifepristone, arguing such restrictions could have dire health implications for individuals residing in states where abortion remains legal.
Dr. Resneck cited extensive research, asserting that hundreds of peer-reviewed studies validate the safety of mifepristone, likening its safety profile to that of ibuprofen.
Following the release of the Ethics and Public Policy report, Dr. Céline Gounder—medical contributor for CBS News and editor-at-large for public health at KFF Health News—contested the validity of the findings, criticizing the report for its lack of transparency and failure to disclose data sources. She also remarked on the absence of a comparison group to provide context for the experiences of pregnant women not taking mifepristone.
A representative from Danco, the manufacturer of mifepristone, expressed strong confidence in the drug’s established safety and efficacy record.
In an email statement to Fox News Digital, Dr. Christina Francis, an OB-GYN and CEO of AAPLOG, condemned the FDA’s deregulation of mifepristone. She argued it exposes pregnant women to unacceptably low standards of care, creating vulnerabilities to life-threatening complications while potentially enabling abuse and trafficking of victims forced into undesirable abortions.
She stated that experiences witnessed by healthcare professionals highlight the urgent need for the FDA to prioritize women’s safety by revaluating mifepristone’s safety and reinstating essential safeguards that should have never been lifted. The additional organizations that endorsed the letter include the Christian Medical and Dental Association, the American College of Pediatricians, and the Coptic Medical Association of North America.
