New Study Challenges FDA's Safety Claims on Mifepristone, Prompting Regulatory Scrutiny

Key Insights

• A controversial study by the Ethics and Public Policy Center claims mifepristone's serious adverse event rate is 10.93%, approximately 22 times higher than the FDA's reported 0.5% rate, prompting calls for reinstated restrictions.
• FDA Commissioner Marty Makary has pledged to review new safety data on mifepristone, while critics question the study's methodology, particularly its broad definition of "serious adverse events" and inclusion of emergency room visits without context.
• The debate highlights tensions between abortion access advocates who cite decades of mifepristone safety data and critics who support reinstating requirements for in-person visits, physician-only prescribing, and stricter gestational limits.

The Ethics and Public Policy Center (EPPC) released a major study Monday revealing that the abortion drug mifepristone may carry significantly higher risks than previously acknowledged by U.S. health agencies. According to the report, the rate of serious adverse complications associated with mifepristone is at least 22 times higher than the 0.5% figure cited by the FDA, with researchers claiming a 10.93% serious adverse event rate.

The findings have prompted Senator Josh Hawley (R-Mo.) to call on FDA Commissioner Marty Makary to reinstate the original safety protocols that were in place when mifepristone was first approved in 2000. "An alarming new study has revealed that the safety risk of the chemical abortion drug, mifepristone, are far greater than the FDA currently acknowledges," Hawley wrote in a letter to Makary.

Study Findings and Methodology

The EPPC study analyzed insurance claim data from 865,727 cases identified as mifepristone-enabled abortions between 2017 and 2023. Researchers Jamie Bryan Hall and Ryan T. Anderson reported that 10.93% of these cases resulted in what they classified as "serious adverse events" within 45 days of taking the medication.

These adverse events were categorized as:

• "Other abortion-specific complications" (49,169 cases)
• Emergency room visits (40,960 cases)
• Hemorrhage (28,658 cases)
• Surgical abortion after medication failure (24,593 cases)
• Infection (11,707 cases)
• Hospitalization (5,699 cases)
• Ectopic pregnancy (3,062 cases)
• "Other life-threatening adverse events" (1,956 cases)
• Blood transfusions (1,257 cases)
• Sepsis (824 cases)

EPPC President Ryan Anderson, who co-authored the study, stated, "The major takeaway here is that it's a 22-times-higher rate of serious adverse events for women who take the chemical abortion drug than what the FDA claims on the label."

Regulatory Implications

Commissioner Makary pledged last week to review new data regarding mifepristone's safety, stating that if emerging data suggests safety concerns, the agency would act accordingly. Health and Human Services Secretary Robert F. Kennedy Jr. has also indicated plans to study the safety of mifepristone.

The EPPC researchers are advocating for the reinstatement of the original FDA requirements, which included:

• At least three in-person office visits
• Prescription limited to physicians only
• Administration in a medical facility
• Use restricted to the first seven weeks of pregnancy
• Prescribing physicians capable of providing surgical intervention if needed

These restrictions were gradually relaxed during the Obama and Biden administrations, with current regulations allowing mifepristone to be prescribed up to 10 weeks into pregnancy, prescribed via telehealth, and delivered by mail.

Methodological Criticisms

Critics have raised significant concerns about the study's methodology and conclusions. They point to several potential issues:

1. Broad definition of "adverse events": The largest category of complications was labeled as "other abortion-specific complications" without clear definition of what these entail.
2. Emergency room visits: Critics note that emergency room visits alone don't necessarily indicate serious complications, as women might seek care for normal bleeding or pain outside regular clinic hours.
3. Inclusion criteria: The study may have included patients prescribed mifepristone for natural miscarriages, not just elective abortions, potentially skewing results.
4. Mental health categorization: The study appears to include certain mental health diagnoses within its adverse event calculations, which critics argue may not be directly attributable to the medication.
5. Expected outcomes: Some events counted as complications, such as surgical abortion after medication failure, fall within the expected failure rate of 2-13% that is already disclosed to patients.

Expert Perspectives

Dr. Donna Harrison, director of research for the American Association of Pro-Life Obstetricians and Gynecologists, supported the study's findings, stating that obstetricians across the country are "seeing women with hemorrhages, women with tissue left inside, women who have ectopic pregnancies that never should have gotten the abortion pill at all."

Harrison emphasized that clinical trials for mifepristone were conducted under controlled circumstances with carefully screened participants, conditions that don't reflect real-world usage. "In the real world, Sally Smith, who may be 14, gets online, gives her gift credit card, and gets mailed mifeprex [the brand name for mifepristone]. She has no idea how far along she is," Harrison explained.

Conversely, critics argue that the study's findings contradict decades of data showing mifepristone's safety profile. They note that comparing complication rates to those of pregnancy and childbirth provides important context, with maternal sepsis occurring in approximately 0.04% of deliveries in the United States.

Legal Context

The debate over mifepristone regulations has already reached the U.S. Supreme Court, which rejected a previous challenge to the FDA's relaxed requirements. The Court ruled that the plaintiffs in that case lacked standing to bring the suit.

With direct legal challenges facing significant hurdles, those seeking stricter regulations appear to be focusing on persuading the FDA to change its policies through new research and political pressure.

Broader Implications

The controversy highlights the ongoing tension between ensuring medication safety and maintaining access to reproductive healthcare. Advocates for maintaining current regulations argue that restricting access to mifepristone could lead to more dangerous alternatives, including black market medications or more invasive procedures.

As the FDA reviews the new data, the outcome could significantly impact abortion access across the United States, particularly in states where surgical abortion is restricted but medication abortion remains available through telehealth and mail services.