FDA Commissioner Is ‘Committed’ to Conducting a Review of Abortion Pill Safety
U.S. Food and Drug Administration (FDA) Commissioner Marty Makary committed on Monday to review the safety of mifepristone, the first drug used in a two-drug medication abortion regimen.
Makary committed to a review of the drug in a letter responding to Sen. Josh Hawley’s (R-MO) concerns about mifepristone, following a the release of a new study suggesting real-world complications from the pill are 22 times higher than what is listed on the FDA-approved drug label.
“FDA is committed to safeguarding public health by ensuring the safety, efficacy, and quality of the products it regulates. The Agency carefully evaluates the scientific data, leveraging rigorous science to make informed decisions. As with all drugs, FDA continues to closely monitor the postmarking safety data on mifepristone for the medical termination of early pregnancy,” Makary said in the letter. “As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data.”
Makary’s pledge to review the drug’s safety comes after Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said in May that he ordered the FDA to conduct a “complete review” of the abortion pill in response to the new study.
The study from the Ethics and Public Policy Center (EPPC) 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 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 Hawley 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.
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.”
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.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton
