The attorneys general, led by Kansas Attorney General Kris Kobach, sent a letter to Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and the Food and Drug Administration (FDA), pointing to the agency’s removal of “important safeguards” around mifepristone under the Obama and Biden administrations, along with a new study suggesting abortion pill complications are 22 times higher than previously reported.
“Recent comprehensive studies of the real-world effects of the chemical abortion drug mifepristone report that serious adverse events occur 22 times more often than stated on the drug’s label, while the drug is less than half as effective as claimed. These facts directly contradict the drug’s primary marketing message of ‘safe’ and ‘effective,’” the letter reads, citing a study from the Ethics and Public Policy Center (EPPC).
The EPPC study found that 10.93 percent of women who had mifepristone abortions 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 the “largest-known study of the abortion pill,” according to the authors, Ethics and Public Policy Center President Ryan T. Anderson and Director of Data Analysis and Fellow Jamie Bryan Hall. 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 — meaning the results of the study are based on real-world incidents.
The study points to the deregulation of the abortion pill after it 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.”
The original FDA-approved drug label for Mifeprex (a brand name for mifepristone) 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.
Both RFK Jr. and FDA Commissioner Marty Makary have pledged to review the abortion pill’s safety following the release of the EPPC study.
The AGs’ letter reads in part:
Both of you are to be commended for taking this new information seriously and committing to conduct a full-scale review of mifepristone and its labeling based on objective data. Based on that review, the FDA should consider reinstating safety protocols that it identified as necessary as recently as 2011 in its issuance of a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, but which were removed by the Obama and Biden administrations.
“Alternatively, in light of the serious risks to women who are presently being prescribed this drug without crucial safeguards, and in the event the FDA is unable to reinstate the 2011 safety protocols for mifepristone,” they write, “the FDA should consider withdrawing mifepristone from the market until it completes its review and can decide on a course of action based on objective safety and efficacy criteria.”
The attorneys general added that the EPPC study “appears more comprehensive than the clinical trials relied on by the FDA in 2016 when it approved label changes that removed most of the critical safeguards that had previously been included.”
“The FDA’s removal of important safeguards starting in 2016 may explain in part why the real-world risk of serious adverse events from 2017–2023 is so much higher than the risk identified in clinical trials cited in mifepristone’s label,” they contended, “which contained many of the safeguards that were later eliminated.”
The letter further states:
The FDA’s removal of these crucial safety protocols in 2016 (and in 2023) that only five years before the FDA considered necessary begs the question of whether the removal was motivated by considerations other than the safety of patients. Now, the EPPC Study reports that in the years since the safeguards have been removed, the risk to women is far higher than was previously thought and far higher than the label indicates. The current FDA’s dedication to the health and wellbeing of all Americans is encouraging, as is the much-needed review of mifepristone that Secretary Kennedy has promised.
Letter to the FDA from 22 state Attorneys General by Breitbart News
Mississippi Attorney General Lynn Fitch, who joined the letter, told Breitbart News on Tuesday she is “hopeful” Kennedy Jr. and the FDA will “stand up for women’s health care.”
“We warn people regularly not to purchase any drugs from unknown sources because of the dangers of fentanyl and counterfeit drugs, but then encourage them to mail-order Mifepristone because politics wins out over their wellbeing,” Fitch said.
“The evidence is clear that there can be serious adverse health impacts for women who use this drug and we do a disservice to women to pretend otherwise,” she continued. “Asking that women have the supervision of a trusted physician is the least we should require and I am hopeful that Secretary Kennedy and the FDA will stand up for women’s health here.”
In a medication abortion, mifepristone — also called by the brand name Mifeprex created by Danco Laboratories — 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.
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 the wake of the Supreme Court’s Dobbs decision overturning Roe v. Wade. Roe had created the “constitutional right” to abortion for 50 years before the high court released its Dobbs decision in 2022, sending the issue back to the states and their elected representatives.
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.”
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.
Earlier this year, three Republican-led states, Idaho, Missouri, and Kansas, were given the go-ahead to proceed with a lawsuit challenging the FDA’s deregulation of mifepristone. The states are challenging the FDA after the Supreme Court ruled in June of 2024 that the pro-life doctors who brought the original lawsuit lacked standing to sue. The high court ultimately did not rule on whether the FDA’s rollback on mifepristone regulations is legal.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton
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