Restoration News has reported that the U.S. Food and Drug Administration (FDA) is under renewed scrutiny regarding its oversight of the abortion drug mifepristone. Critics have accused the agency of negligence under previous administrations and are calling for a comprehensive safety review.
According to Restoration News, the 2003 death of 18-year-old Holly Patterson following a chemical abortion was a catalyst for public scrutiny of mifepristone. Her father, Monty Patterson, discovered through public records that multiple women had died from bacterial infections linked to the drug. This discovery led him to advocate for stronger safeguards from the FDA, which eventually resulted in a warning about serious infections being added to the Mifeprex label. However, critics argue that the FDA's response was too slow in protecting women at risk.
The Ethics and Public Policy Center (EPPC) conducted a study indicating that the serious adverse event rate for chemical abortions is nearly 11 percent, significantly higher than FDA figures suggest. The analysis also showed a failure rate of at least 5.26 percent, meaning approximately one in every 19 chemical abortions requires surgical or medical follow-up. EPPC concluded that FDA safety data significantly underestimates risks, raising questions about whether the agency is accurately informing the public.
ProPublica has reported that FDA records list 36 deaths associated with mifepristone use as of December 2024. However, independent researchers claim this number is likely much higher due to systemic underreporting. A peer-reviewed study cited by ProPublica found that between 2016 and 2021, 83.5 percent of chemical abortion-related emergency room visits were miscoded as miscarriages. Critics argue that by not requiring full reporting of complications, the FDA has limited transparency and made it difficult to assess the real risks of mifepristone.
As reported by The New York Times, during the Obama administration in 2016, the FDA extended the gestational age for mifepristone use from seven to ten weeks and reduced required in-person visits. Later, during the COVID-19 pandemic, the Biden administration suspended in-person dispensing requirements, allowing the drug to be mailed directly after telehealth consultations. Supporters viewed these changes as enhancing access while critics warned they increased safety risks by removing medical supervision and enabling online sales through potentially unregulated providers.
According to its official website, the U.S. Food and Drug Administration is a federal agency under the Department of Health and Human Services responsible for regulating food, drugs, vaccines, and medical devices to protect public health. Established in 1906, it enforces regulations such as the Food, Drug, and Cosmetic Act while reviewing new drug applications and overseeing post-market safety monitoring.
