In a landmark ruling for women’s health, a federal district court judge in Texas ruled on Good Friday that the FDA’s approval of the chemical abortion drug, mifepristone, was illegal. The drug endangers women, and the FDA’s approval and subsequent deregulation of the drug violates federal law. The decision is a tremendous win for maternal health and for the protection of unborn life.
The chemical abortion drug Mifepristone—also known as RU-486 or Mifeprex—works by blocking the hormone progesterone, disrupting nutrition, and ultimately starving an unborn child to death. It can be taken up until ten weeks of pregnancy and the FDA recently made it available by mail. The Biden administration has repeatedly pushed the availability of the chemical abortion drug, suggesting it should be used even in states which prohibit abortion. Yet according to the federal court, the dangerous drug should never have been approved in the first place.
Instead, the FDA put politics above women’s safety. The Clinton administration rushed mifepristone through an expedited review designed to approve HIV drugs. That review process required the FDA to conclude “pregnancy” is “a serious or life-threatening illness.” But as Judge Matthew J. Kascmaryk held, “pregnancy is not an illness” but “a natural physiological state that most women experience.” Nor do chemical abortion drugs provide the requisite “meaningful therapeutic benefit.” The drugs cannot be considered “therapeutic” because they do not treat any disease.
Further, chemical abortion is dangerous. It harms thousands of women and always results in the death of an unborn child. In fact, the FDA has approved mifepristone under a program that only applies to drugs with known and severe adverse complications. One in five women who take chemical abortion drugs have complications including severe bleeding, life-threatening infections, and the inability to have a successful future pregnancy.
As the federal court concluded, studies show that more women suffer complications from chemical abortion than even surgical abortions and 50 percent more will end up in the emergency room within 30 days. And many women will end up needing surgical abortions anyway. Indeed, FDA’s own numbers show that between 5 and 8 out of every hundred women will require surgical intervention to either stop severe bleeding or complete the abortion. Additionally, the court found that “thirty-eight percent of women reported issues with anxiety, depression, drug abuse, and suicidal thoughts” after a chemical abortion.
In truth, chemical abortion has never been more dangerous. The FDA recently removed the most basic of safeguards—an in-person doctors’ appointment—and allowed for mail-order abortions obtained simply by filling out an online form. Even before the FDA removed the in-person dispensing requirement “the number of chemical abortion-related emergency room visits increased by over five hundred percent between 2002 and 2015.” As Judge Kascmaryk noted, these numbers are only going to increase under the FDA’s mail-order abortion regime. Without an in-person visit, a doctor cannot diagnose an ectopic pregnancy or accurately assess gestational age—factors that put a woman’s life and health in danger.
As my colleague Erik Baptist, who represents plaintiffs in the case on behalf of Alliance Defending Freedom put it, “the FDA never had the authority to approve these drugs and remove important safeguards, despite the substantial evidence of the harms women and girls who undergo this dangerous drug regimen could suffer.”
The plaintiff doctors in the case, for instance, often treat women suffering adverse consequences from chemical abortion. One doctor tells of an emergency surgical abortion required to save the mother’s life after a chemical abortion, even though an ultrasound detected a faint fetal heartbeat. And many of the plaintiff doctors describe patients suffering life-threatening conditions from chemical abortions obtained through the mail.
The Texas court put its decision on hold for seven days to allow the FDA to appeal the ruling. And just hours after the Texas decision came down a federal district court in Washington issued an order prohibiting the FDA from changing its requirements regarding the chemical abortion drug. The legal battle is far from over but a federal court has finally recognized the tremendous harm caused to women (and their children) by chemical abortion.
Putting a stop to chemical abortions is a win for women’s health. It is a win for states and the people who can protect unborn lives. It is a win for doctors forced into feeling complicit in elective abortions. And it is a win for the rule of law.
The author works for Alliance Defending Freedom and represents plaintiffs in this case.