FDA Commissioner Reviews Mifepristone Safety
On Monday, FDA Commissioner Marty McCurry announced a commitment to review the safety of Mifepristone, the first medication in a two-drug abortion regimen. This decision came in response to a letter from Senator Josh Hawley (R-MO), who raised concerns following a new study indicating potential complications associated with the drug.
In his communication, McCurry emphasized the FDA’s commitment to public health, noting that the agency rigorously assesses scientific evidence to make informed decisions. “As the food drug commissioner, I am dedicated to conducting a review of Mifepristone in collaboration with professional career scientists here,” he stated.
McCurry’s review aligns with a directive from Health and Human Services Director Robert F. Kennedy Jr., who requested a comprehensive examination of abortion drugs due to emerging research findings.
According to new research from the Ethics and Public Policy Center (EPPC), approximately 10.93% of women who used Mifepristone experienced severe complications, such as sepsis or severe bleeding, within 45 days of the procedure. This figure vastly exceeds the less than 0.5% reported during clinical trials, based on an analysis of over 865,000 Mifepristone abortions conducted from 2017 to 2023.
“That’s surprising,” Kennedy Jr. remarked when discussing the study during a Senate hearing. He urged the FDA to conduct a thorough review and provide a detailed report.
He also noted that the findings suggest a need for changes to drug labeling to reflect the new data correctly.
The implications of the EPPC study call for a reinstatement of protections around Mifepristone, originally developed by Danco Laboratories under the brand name Mifeprex. The drug gained rapid approval in 2000 during the Clinton administration, with stipulations that labeled unwanted pregnancy as a serious condition and required it to demonstrate effectiveness over surgical abortion.
The initial FDA-approved Mifeprex label indicated its use up to seven weeks into a pregnancy and included several health safeguards. These measures entailed:
- Three consultations with healthcare providers
- Prescriptions from doctors who understand the medication
- Administration of the drug in clinical settings, ensuring proper oversight
- Access to surgical intervention in emergencies
- Medical facilities equipped for potential complications
However, these safeguards have been absent from the approval process for the past two decades.
Recent changes during the Obama and Biden administrations have relaxed risk assessment protocols. As it stands now, women can receive Mifepristone after just one virtual visit with a healthcare provider, who doesn’t have to be a physician.
Since 2016, the FDA has also ceased requiring prescribers to report serious adverse incidents, aside from fatalities.
Some pro-abortion groups, such as Planned Parenthood, argue that these regulations are crucial to improving access to abortion services post the Dobbs decision which overturned Roe v. Wade.
Conversely, the American Pro-Life Association has criticized the relaxed regulations, stating they pose risks to women, particularly concerning undiagnosed ectopic pregnancies.
“Abortion drugs can lead to severe complications, including ruptures in ectopic pregnancies,” the author of the study pointed out, stressing that the FDA should reinforce safeguards to protect women.
In 2023, medication abortions accounted for a significant 63% of all abortions within the U.S. healthcare system, according to the Guttmacher Institute. This figure has increased from 39% in 2017.
Mifepristone works by blocking progesterone, which is essential for pregnancy maintenance. When progesterone is inhibited, the uterine lining deteriorates, leading to the termination of the pregnancy. The second medication, Misoprostol, induces contractions to expel the pregnancy from the uterus.
