Discussion on Mifepristone Safety Data
The Director of Health and Human Services (HHS), Robert F. Kennedy Jr., has accused the Biden administration of distorting safety data related to an abortion drug. During a Senate Finance Committee hearing, Kennedy spoke about the Trump administration’s healthcare policies, addressing concerns about Mifepristone, the drug that’s part of a two-drug abortion method. Senator James Lankford (R-OK) brought up the issue, questioning the HHS secretary about the FDA’s review process for Mifepristone, especially following reports of complications associated with the drug since April.
Lankford stated, “You have issued an official statement on this, and the FDA commissioner has made his comments about safety evaluations for Mifepristone. Initially, you mentioned that all medications should be assessed similarly, without political bias. Yet, there have been significant modifications in how Mifepristone is accessible for abortions under this administration. It’s now available without a prescription, which complicates matters.”
He then asked, “So, can you tell us about the review’s timing to ensure safety protocols are being followed?”
Kennedy Jr. noted that he could not provide specific timing for the review but mentioned that he spoke to FDA Commissioner Marty McCurry, who suggested the review process is “advanced.”
“We’re continuously collecting new data for review. It appears that, during the Biden administration, there has been a manipulation of data that suggests an 11% complication rate, which is concerning,” Kennedy Jr. claimed. “Our goal is to uphold integrity in scientific assessment.”
He previously mentioned in May that he had requested a comprehensive review of abortion drugs from the FDA. A study found that 10.93% of women who received Mifepristone faced severe complications, such as infections and bleeding, within 45 days of taking the drug. This figure starkly contrasts with the less than 0.5% rate noted in FDA clinical trials. This analysis was derived from data involving over 865,000 Mifepristone prescriptions from 2017 to 2023.
“That’s quite remarkable,” Kennedy Jr. remarked regarding the study’s findings when discussing it with Senator Josh Hawley (R-MO) during a Senate Health, Labor, Education, and Pensions Committee meeting.
He reiterated his request for a thorough review from FDA Director McCurry.
In a response to Senator Hawley in June, McCurry assured him that the agency would confirm the safety of Mifepristone.
“The FDA is dedicated to safeguarding public health by ensuring the safety and effectiveness of its products. We rigorously assess scientific evidence to make informed decisions. As a commissioner, I am resolute in conducting an evaluation of Mifepristone,” McCurry stated.
In 2023, medication abortions represented 63% of all abortions within the U.S. healthcare system, according to the Guttmacher Institute. This accounted for about 642,700 abortions and an increase from 53% in 2020 and 39% in 2017. However, the report did not factor in abortions via underground networks that supply medication to women in restrictive states.
Mifepristone works by blocking the progesterone hormone necessary for sustaining pregnancy. When this hormone is inhibited, the uterine lining detaches, leading to the loss of the fetus. The subsequent drug, misoprostol, induces contractions to expel the fetus from the uterus.
