Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. on Wednesday said he has ordered the U.S. Food and Drug Administration (FDA) to conduct a “complete review” of the abortion pill after a shocking study was released last month suggesting a higher complication rate than previously reported.
A study from the Ethics and Public Policy Center (EPPC) found that 10.93 percent of women who had mifepristone abortions — the first drug used in a two-drug medication abortion regimen — experienced severe complications including sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following the abortion. This percentage is significantly higher than the less than 0.5 percent in clinical trials reported on the FDA-approved drug label. The study is based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.
“It’s alarming,” Kennedy Jr. said of the study’s findings when questioned about it by Sen. Josh Hawley (R-MO) at a Senate Health, Labor, Education and Pensions (HELP) Committee hearing.
“I have asked Marty Makary, who is the director at FDA, to do a complete review and report back,” he added.
“Clearly [the study] indicates, at the very least, that the label should be changed,” Kennedy Jr. told the senator.
Kennedy Jr. notably pledged during his confirmation hearing to study the safety of the abortion pill. Specificially, Sen. James Lankford (R-OK) noted how the Food and Drug Administration (FDA) stopped requiring the reporting of all complications related to abortion drugs in 2016, with the exception of deaths. He also pointed out how the FDA under Biden allowed abortion pills to be prescribed over telehealth and sent via mail, potentially putting women who have undiagnosed ectopic pregnancies and other complications at risk.
Lankford asked:
My question to you is, will FDA move to be able to actually give transparency to the American people and to say [mifepristone] is no different than any other drug? [That] we are not going to protect it just because [abortion] is political for some folks? People should know side effects of this drug and there should be reporting.
“It’s against everything we believe in this country that patients or doctors should not be reporting adverse events,” Kennedy Jr. replied. “We need to know what adverse events are. We need to understand the safety of every drug — mifepristone and every other drug. President Trump has made it clear to me that this is one of the things he has not taken a position yet on, a detailed position, but he’s made it clear to me that he wants me to look at safety issues, and I’ll ask NIH and FDA to do that.”
Before the study was released, Makary said he has “no plans to take action” to restrict the availability of mifepristone, but he said there is a possibility the FDA could take action if future data reveals dangers of the drug.
“There is an ongoing set of data that is coming into the FDA on mifepristone,” he said. “So if the data suggests something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data.”
EPPC’s main call to action following the results of the study is for the FDA to reinstate its earlier safeguards around mifepristone, which is created by Danco Laboratories and goes by the brand name Mifeprex.
Mifepristone was fast-tracked for approval in 2000 during the Clinton administration under a process that required unwanted pregnancy to be classified as a “serious or life-threatening illness” and the drug had to be proved more effective than surgical abortion, the study details.
The original FDA-approved drug label for Mifeprex from September of 2000 said the drug should be used through approximately 7 weeks of pregnancy. Its use also required “several modest safeguards for women’s health,” the study notes. Safeguards included:
- Three office visits by the patient
- A prescription given only by physicians who have read and understand prescribing information
- Administration of the drug in a clinic, medical office, or hospital, by or under the supervision of a physician able to assess the gestational age of an embryo and to diagnose ectopic pregnancies
- The presence of a physician who is able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or plans for such care through others
- Patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
But these safeguards have been chipped away over the past two decades since the drug’s approval.
Following actions from the Obama and Biden administrations, the drug’s current Risk Evaluation and Mitigation Strategy (REMS), which has been in effect since 2023, allows women to obtain mifepristone with one telehealth visit with any approved healthcare provider (not necessarily a physician), allows women to self-administer the drugs obtained from a mail-order pharmacy, and allows women to take the drugs up to ten weeks gestation instead of seven weeks.
The FDA also stopped requiring prescribers to report serious adverse events other than deaths in 2016.
Pro-abortion groups like Planned Parenthood and The American College of Obstetricians and Gynecologists (ACOG) have contended scrapping these regulations is necessary in order to increase access to abortions, especially in wake of the Supreme Court’s Dobbs decision overturning Roe v. Wade. Roe had created the constitutional “right” to abortion 50 years before before the high court released its Dobbs decision in 2022, sending the issue back to states and their elected representatives.
The American Association of Pro-Life OBGYNs (AAPLOG) counters that relaxing regulations around mifepristone puts women at risk. Specifically, they warn a lack of in-person evaluation could put women at risk of having undiagnosed ectopic pregnancies or miscalculating how far along they are.
“The abortion pill can cause an ectopic pregnancy to burst and put the woman’s life in danger. Yet we find that roughly one in 300 women who takes the pill in the real world is diagnosed with an ectopic pregnancy after she has already taken the pill,” the study’s authors previously told Breitbart News. “The FDA must reinstate stronger safeguards to prevent this from happening.”
“The further along the woman is in her pregnancy, the larger and more developed her unborn child is, the greater the risk of complications from the abortion pill, such as retained fetal parts,” they continued. “By tightening gestational age limits and requiring the doctor to accurately assess gestational age before prescribing the pill, the FDA can reduce the risk of harm to the woman.”
The study is the first in a series investigating women’s health and abortion using real-world data. EPPC released a second report on Monday using the same insurance claims data, suggesting the real-world failure rate of a mifepristone abortion is at least 5.26 percent, which is double the failure rate reported on the FDA-approved drug label.
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In 2023, medication abortions accounted for 63 percent of all abortions within the formal U.S. healthcare system — meaning an estimated 642,700 unborn babies died in medication abortions, according to the pro-abortion Guttmacher Institute. The percentage was up from an estimated 53 percent in 2020 and 39 percent in 2017. The report did not account for abortion pills obtained through underground national and international networks, including those that send pills to women in states with abortion restrictions.
In a medication abortion, mifepristone blocks the action of progesterone, which the mother’s body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mother’s uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mother’s womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mother’s uterus.
Danco Laboratories says on its website that “although cramping and bleeding are an expected part of ending a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion, or childbirth.”
“Seeking medical attention as soon as possible is needed in these circumstances. Serious infection has resulted in death in a very small number of cases. There is no information that use of Mifeprex and misoprostol caused these deaths,” the website states. “If you have any questions, concerns, or problems, or if you are worried about any side effects or symptoms, you should contact your healthcare provider.”
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton
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