FDA should limit access to ‘dangerous’ chemical abortion drugs, doctors argue in lawsuit

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A group of doctors and medical organizations, including the American Association of Pro-Life Obstetricians and Gynecologists, argue in a federal lawsuit that the Food and Drug Administration (FDA) “chose politics over science” when, over two decades ago, it approved the two-drug regimen collectively known as the abortion pill.

The Nov. 18 lawsuit, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, was filed in the U.S. District Court for the Northern District of Texas, Amarillo Division. Attorneys for Alliance Defending Freedom, a Christian legal group, filed the lawsuit on behalf of the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, and doctors Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado.

In the more than 100-page lawsuit, the doctors argue that the FDA fast-tracked the approval of the abortion pill by classifying pregnancy as an “illness” and falsely asserting that abortion drugs provide a “meaningful therapeutic benefit” over surgical abortions, neither of which is the case, they say. They also note that the FDA has not performed studies on the effects of abortion drugs on minor girls.

The plaintiffs hope to persuade the federal court to issue a preliminary and permanent injunction ordering the FDA to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs. Among other serious concerns, the plaintiffs present evidence that women and girls who take chemical abortion drugs experience significantly more complications than those who have surgical abortions.

“[T]he FDA never studied the safety of the drugs under the labeled conditions of use despite being required to do so by the Federal Food, Drug, and Cosmetic Act (FFDCA),” the lawsuit asserts.

“The agency also ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls in violation of the Pediatric Research and Equity Act (PREA). And the FDA disregarded the substantial evidence that chemical abortion drugs cause more complications than even surgical abortions.”

The plaintiffs also pointed to the fact that the FDA has progressively rolled back safeguards on the abortion pill; for example, the FDA in 2016 extended the permissible gestational age of the baby to be killed in the abortion from seven to 10 weeks, increasing — as studies have demonstrated — the risk of complications for the mother.

And more recently, the FDA lifted certain restrictions on mifepristone distribution in December 2021, authorizing doctors to prescribe the drugs online and mail the pills, allowing pregnant women to perform early abortions without leaving their homes.

The FDA declined comment, saying in a statement, "The FDA does not comment on possible, pending or ongoing litigation."

The FDA first approved mifepristone, which is paired with another drug called misoprostol, for earlier abortions in 2000. This type of abortion is currently approved by the FDA for use up to 10 weeks’ gestation. Mifepristone is designed to block progesterone, the hormone that sustains pregnancy, effectively starving the baby. The second pill in the abortion pill regimen, misoprostol, induces labor.

This type of abortion now accounts for more than half of all abortions in the U.S., according to the Guttmacher Institute, a reproductive research organization once associated with Planned Parenthood.

Abortion supporters have pointed to medical abortions as a kind of workaround or backup plan for women to access abortion as states restrict abortion, especially after the Supreme Court in June overturned Roe v. Wade, the 1973 decision that legalized abortion nationwide. Abortion doctors from outside of states that have restricted abortion — even from as far away as Europe — have been sending abortion pills to women in defiance of the states’ pro-life laws.

In early November, the FDA warned about the dangers of health professionals prescribing abortion drugs to women before they are pregnant, citing the potential for major complications.

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