Courts Can Correct the FDA's Mifepristone Malpractice | Opinion

Like approximately 90 percent of my fellow OB/GYNs, I don't perform elective abortions. But I've personally treated many women for complications from the abortion pill (mifepristone and misoprostol), including performing a recent emergency surgery on a woman who bled for two months after receiving these drugs.

Sadly, this was no isolated incident. Major international and U.S. studies show that complications occur four times as often with the abortion pill, compared with surgical abortion, affecting as many as one in five women who take these drugs. And yet the U.S. Food and Drug Administration (FDA) continues to downplay or ignore readily available data and put women's lives and health at risk.

That's why the Texas district court's Good Friday ruling halting FDA approval of the abortion pill—followed by a Fifth Circuit ruling that would restore key safeguards that existed pre-Obama and pre-Biden, if upheld at the Supreme Court this week—is a win for the safety of women and girls across the United States. As demonstrated by a coalition of medical organizations and doctors in Alliance for Hippocratic Medicine (AHM) v. U.S. FDA, the FDA failed to follow its own rules in approving the abortion pill.

The evidence that abortion pills are dangerous is overwhelming—and by approving them, the FDA chose a radical political agenda over women's health.

Peer-reviewed research from the Lozier Institute, based on a longitudinal, records-linkage analysis of nearly a half million abortions over 17 years and cited in AHM v. FDA, found a 53 percent greater risk for an emergency room visit after the use of the abortion pill than after a surgical abortion. This analysis also documented that in 2015 over 60 percent of abortion pill-related ER visits were miscoded as the result of miscarriage, falsely inflating claims of the abortion pill's safety and endangering women's health. In fact, Medicaid data shows that the rate of abortion pill-related emergency room visits is up more than 500 percent since mifepristone was approved in 2000.

Shockingly, the FDA fast-tracked the abortion pill using its accelerated drug approval authority, ludicrously designating pregnancy as a "serious or life-threatening illness." As many as seven percent of women who use abortion pills early in pregnancy will need follow-up surgery, up to 15 percent will experience hemorrhage, and two percent will have an infection. No big deal, according to abortion advocates. But not to the thousands of women who experience these dangerous complications every year.

The do-it-yourself abortion pill, seen by abortion advocates as their best option to get around last year's Supreme Court ruling in Dobbs v. Jackson and continue committing abortions in states that have chosen to protect unborn human life, is anything but simple, and is decidedly not safe.

The FDA has a long history of inappropriate decisions regarding mifepristone. For one, the agency ignored its own rules by performing no focused studies on girls under 18 before approving mifepristone for use on them. Does the drug impact adolescent development? Affect future fertility? No one knows.

Then, in 2016, mifepristone's use was expanded from seven to 10 weeks' gestation, despite limited studies on very few women, documenting far more failures when used by women at a later gestational age. The Fifth Circuit decision moved it back to seven weeks. Incredibly, the FDA decided it no longer cared to hear of any complications unless they actually killed a woman. It eliminated the requirement for doctors and others to report nonfatal serious side effects, then cited the lack of those reports as an indication that the drug was safe. "This ostrich's-head-in-the-sand approach is deeply troubling," the Fifth Circuit said.

Next, in 2021, using the COVID-19 pandemic as an excuse, the FDA removed the requirements for in-person distribution of mifepristone and allowed the abortion pill to be ordered online and delivered through the mail. In early 2023, it went further, approving distribution through pharmacies. As a result, many women are now getting abortion pills without ever receiving a physical exam, ultrasound, or having blood work to screen for potential complications. The Fifth Circuit also rolled back these reckless policies.

Women and doctors like me have seen the real-world consequences of the FDA's policy. Without an ultrasound, it's easy to underestimate the gestational age, which in turn leads to higher failure rates and need for surgeries, often in emergency conditions. Chemical abortion in the second trimester fails up to 39 percent of the time. Because the abortion pills only affect pregnancies inside the uterus, failure to conduct an ultrasound will lead to ectopic pregnancies rupturing, catastrophic internal bleeding, and possibly maternal deaths. Sadly, without personal interaction to confirm that the person requesting the pills is a woman voluntarily seeking abortion, the pills may be obtained by sex traffickers, incestuous abusers, and male partners who don't want to take responsibility for their fatherhood, increasing the risk of coercion and unwanted abortions.

Incredibly, abortion advocates are still encouraging the use of unsafe abortion pills in states with pro-life laws. In going along with them, the pro-abortion ideologues at the FDA have neglected their duty to protect American women. Those promoting unsupervised DIY abortion pills clearly prioritize the deaths of unborn children over the health and safety of women. When the Supreme Court has the chance to review the facts, I hope the FDA will once and for all be held accountable to its task of protecting the American public from this dangerous drug.

Ingrid Skop, M.D., is vice president and director of medical affairs for Charlotte Lozier Institute. She is a board-certified obstetrician/gynecologist who practices in Texas.

The views expressed in this article are the writer's own.