FDA Failed to Protect Women and Girls from Dangerous Drugs: The Texas Chemical Abortion Lawsuit

By Paul DeBeasi.

The battle lines have been drawn. Pro-abortion physicians claim that the chemical abortion drugs mifepristone and misoprostol are as “safe as Tylenol." In contrast, pro-life physicians warn that they are “dangerous for women and girls.” The FDA escalated this conflict in January 2023 when they allowed retail and mail order pharmacies to dispense these drugs. In addition, there are dozens of websites such as www.heyjane.com that sell chemical abortion kits and enable women and girls to self-manage their chemical abortion.

In November 2022, the Alliance for Hippocratic Medicine, an organization that upholds and promotes the fundamental principles of Hippocratic medicine, filed suit in a Texas district court against the Food and Drug Administration (FDA). They contend that the FDA failed to protect women and girls when they “chose politics over science” and approved these chemical abortion drugs in the United States. They request that the court issue an injunction ordering the FDA to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs and to withdraw the FDA’s actions to deregulate these drugs. 

Chemical Abortion Drugs Pose Dangers to Women and Girls

Prominent medical associations such as the American College of Obstetricians and Gynecologists (ACOG) claim that chemical abortion is safe and effective for women and girls. Well-known media organizations such as Scientific American echo this narrative and state that any claims to the contrary are not “based in science” and are “misinformation.” However, the Texas lawsuit documents many dangers that chemical abortion drugs pose for women and girls. Some of these dangers are listed below.

Increased risk as baby’s gestational age increases. In 2016 the FDA broadened the use of chemical abortion from seven weeks to 10 weeks gestation. But risks to women and girls increase as their baby’s gestational age increases. In addition, women frequently underestimate gestational age by a month or more1. A study of 27,030 pregnant women and girls undergoing chemical abortion showed that after nine weeks gestation, more than six times as many women and girls required a surgical abortion, almost four times as many experienced an incomplete abortion, and almost twice as many suffered an infection, compared with women and girls having babies of younger gestational age2. Another study of 18,248 women and girls showed that an average of thirty-nine percent of women would require surgery if chemical abortion drugs were taken in the second trimester2

BOTTOM LINE: Women and girls that consume chemical abortion drugs are at higher risk of medical complications as their baby’s gestational age increases. 

Heightened risk of undiagnosed ectopic pregnancy. ACOG states that ectopic tubal pregnancy (when the baby implants in the Fallopian tubes rather than the uterus) is “an unstable patient in a medical emergency that requires prompt surgical intervention3.” Clinicians use an ultrasound to diagnose ectopic pregnancy. But the symptoms of ectopic pregnancy (i.e., abdominal pain and bleeding) are the same symptoms a woman or girl will likely experience after consuming chemical abortion pills. Will women and girls who consume chemical abortion drugs and experience these symptoms know when they have an undiagnosed ectopic pregnancy?

BOTTOM  LINE: Women and girls who consume chemical abortion drugs are at heightened risk of undiagnosed ectopic pregnancy, thus exposing themselves to grave medical risks. 

Elevated risk of alloimmunization. Women and girls with Rh-negative blood are at risk of alloimmunization. This medical condition can occur if a Rh-negative mother carries a Rh-positive fetus and the baby's cells mix with the mother's cells. In this situation, the mother’s body creates antibodies to the baby’s blood cells. Alloimmunization can be disastrous for future pregnancies, resulting in stillbirth, brain injury, or neonatal death1. ACOG recommends that pregnant women with Rh-negative blood receive Rh D immune globulin before chemical and surgical abortion to prevent alloimmunization4. Will women and girls seeking chemical abortion know they must check their blood type and, if necessary, contact a health care professional to receive the Rh D immune globulin? 

BOTTOM LINE: Women and girls who consume chemical abortion drugs have an elevated risk of alloimmunization, thus jeopardizing the life and health of their baby in future pregnancies.

Greater risk of complications compared to surgical abortions. Many pro-abortion advocates claim that chemical abortion is safer than surgical abortion. But a study of 42,889 pregnant women undergoing chemical and surgical abortion showed that hemorrhage is over seven times higher with chemical abortion (15.6%) versus surgical abortion (2.1%)2. Another study of 423,000 abortions showed that chemical abortions are over fifty percent more likely than surgical abortions to result in an emergency department visit within thirty days post-abortion2

BOTTOM LINE: Women and girls seeking chemical abortion are at greater risk of adverse medical events than surgical abortion. 

FDA Actions Cause Injury to Patients

The lawsuit also alleges that actions taken by the FDA caused injury to patients. For example, 

FDA failed to require a study of the effects of chemical abortion on girls under 18. The FDA cited three studies to justify their decision that chemical abortion drugs were safe for girls. One study was from the drug manufacturer Danco Laboratories, a second was from Planned Parenthood, and a third was a study of 28 teenage girls undergoing a chemical abortion. The FDA never addressed the potential for conflict of interest or bias in these studies, nor did they handle the small sample size. The FDA also did not require any studies on the long-term effects of chemical abortion drugs on girls under 18.

BOTTOM LINE:  The FDA failed to protect girls under 18 from the dangers of chemical abortion. 

FDA removed the requirement to report non-fatal adverse events. In 2016 the FDA removed the requirement that prescribers report non-fatal adverse events (e.g., hemorrhage, sepsis, retained fetal parts) to the FDA, thus creating an understated drug risk profile. At the same time, they broadened the use of chemical abortion from seven weeks to 10 weeks gestation.  

BOTTOM LINE: Women and girls will never know of the dangers posed by chemical abortion.

FDA removed the in-person drug administration requirement. In 2021 the FDA removed the in-person drug administration requirement, thus opening the door to self-managed chemical abortion. 

BOTTOM LINE: Women and girls who self-manage their chemical abortion are at heightened risk of the dangers posed by underestimated gestational age, undiagnosed ectopic pregnancy, and untreated Rh-negative mothers.

FDA Has Failed Women and Girls

The FDA is responsible for protecting public health by ensuring drug safety, efficacy, and security. But the lawsuit alleges that the FDA failed America’s women and girls when they approved chemical abortion drugs for use in the United States and when they removed even the most essential safeguards for their use. Judge Matthew J. Kacsmaryk presides over the case as plaintiffs, defendants, and other interested parties submit filings to the court. To learn more, refer to the notes below. 

  1. Charlotte Lozier Institute article. http://bit.ly/3Hq924i 
  2. Texas FDA lawsuit. https://bit.ly/40gzLsD 
  3. ACOG Practice Bulletin 193. http://bit.ly/3HJFvUx 
  4. ACOG Practice Bulletin 181. http://bit.ly/3HIJAZ8 
  5. Justia Dockets & Filings. http://bit.ly/3Dt5qgG