One of the authors of a shocking new study suggesting abortion pill complications are 22 times higher than reported on the U.S. Food and Drug Administration (FDA)-approved drug label is calling on the agency to use real-world data to conduct its own research.
A study from the Ethics and Public Policy Center (EPPC) released at the end of April 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, which author and EPPC President Ryan T. Anderson said the FDA could easily access to conduct its own study. Anderson previously said he believes the study is the largest to date on the safety of the abortion pill.
“They don’t need to take my word for this,” Anderson said during an appearance Monday on Breitbart News Daily. “…Our data set entails Medicaid and Medicare, Tricare, the VA system, plus private insurance, like Blue Cross, Blue Shield, Cigna — [The FDA] ha[s] access to all of the government-run data, and they can buy all of the private data. There are over a dozen insurance brokers who sell this data set. They can conduct their own study, right?”
“We [raised] the red flag. We rang the warning bell. Now you guys conduct your own study. Look at your own government health insurance data, purchase the private health insurance data, look through what the real world outcomes are for these real women…” he added.
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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.”
Anderson told Breitbart News Daily host Mike Slater that reinstating Clinton-era regulations is “a relatively commonsense request of the FDA.”
“And it shouldn’t be a big lift,” he said. “It shouldn’t be controversial to say if we’re going to have the abortion pill, it at least needs to be safe for the mother. And then we can have the further conversation about, well, is it ever safe for the baby? Should we have this thing at all? But a starting point should be at least going back to where we were during the Clinton administration.”
“It’s amazing how if we just go back to the Clinton admin, we’re going to get all these — what are now viewed as ‘crazy right-wing’ policies. But no, the Clinton FDA required these safety protections for a reason. Obama and Biden got rid of them for political reasons,” he contended.
Anderson also argued that reinstating the original mifepristone safety regulations would deliver on President Trump’s “Make America Healthy Again” (MAHA) agenda, while also keeping in line with Trump’s view that abortion laws should be set by the individual states.
“One of the major campaign promises that President Trump and …now [HHS Secretary Robert F. Kennedy Jr.] made was to Make America Healthy Again. You can’t Make America Healthy Again when you have a pill on the market that causes one in nine women to experience a serious complication,” Anderson said. “We wouldn’t allow this for any other medication, especially not an elective medication. We realize that chemical abortion doesn’t actually treat an illness. It’s entirely elective, and it’s meant to kill a baby. Are we also okay with having one in nine women suffer as a result of this? So, if MAHA is part of the MAGA coalition, this is not making America healthy again.”
“Then lastly, [Trump] promised that he would leave [abortion] to the states — and I disagree with that — but look, even if that’s your…starting point, you can’t leave it to the states so that California can mail chemical abortion pills to all 50 states, right? That’s allowing one very blue pro-abortion state to set abortion policy for the entire country,” he said.
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.
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.”
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Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton