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Fifth Circuit Partially Sides with Pro-Life Doctors in Abortion Drug Ruling

April 13, 2023

On Wednesday, the U.S. Court of Appeals for the Fifth Circuit sided in part with the Alliance for Hippocratic Medicine, a group of pro-life physicians being represented by Alliance Defending Freedom (ADF), in a lawsuit seeking to revoke Food and Drug Administration (FDA) approval of the chemical abortion drug regimen. The Fifth Circuit ruling comes in response to the FDA’s appeal of a ruling from a Texas federal judge who sided with the plaintiffs against the FDA.

The Court of Appeals ruled to keep a portion of the federal district court’s order in place, restoring health safeguards for women and girls that had been removed by the FDA in 2016. The Department of Justice said Thursday that it plans to escalate the case to the Supreme Court, where the justices will have the opportunity to rule definitively on the statute of limitations surrounding the original 2000 FDA approval and determine whether the chemical abortion regimen will be entirely removed from the market or not. The DOJ will request that the Supreme Court absolve the FDA from abiding by the prior safety regulations that are set to be reinstated on Saturday.

The Fifth Circuit’s ruling highlighted the unique nature of the FDA’s approval of the chemical abortion regimen — including the conscience concerns surrounding it. The brief spoke to the concerns of pro-life physicians who find themselves complicit in committing abortions due to the high complication rate of chemical abortion drugs, which is four times that of surgical abortions, often resulting in trips to the emergency room to complete the abortion.

“The doctors also face injury from the irreconcilable choice between performing their jobs and abiding by their consciences,” the brief stated. “These doctors structured their careers so they would not have to administer abortions. And yet, because women often come to hospitals when they experience complications from these drugs, these doctors sometimes have no other choice but to perform surgical abortions.”

Despite their significant rise in popularity in recent years, now making up well over 50% of all abortions in the United States, chemical abortion drugs carry known safety risks. Since its initial approval in 2023, the FDA has walked back safety regulations on several occasions, including the requirements that are now reinstated under the Fifth Circuit’s orders. These safety requirements include in-person visits to the prescribing physician in order to assess gestational age of the baby and certify that the pregnancy is not ectopic, as well as limiting the timeframe to seven weeks of gestation instead of the expanded 10 weeks.

“FDA’s principal contention to the contrary is that mifepristone is comparable to ‘ibuprofen,’” the Fifth Circuit wrote. “The theory appears to be that we cannot recognize plaintiffs’ standing here without opening a pandora’s box in which doctors have standing to litigate everything at all times, including the banalities of over-the-counter Advil. We disagree because FDA’s own documents show that mifepristone bears no resemblance to ibuprofen. In the 2000 Approval, FDA imposed a ‘Black Box’ warning on mifepristone. FDA requires ‘Black Box’ warnings when a drug ‘may lead to death or serious injury.’”

The removal of the chemical abortion regimen from the U.S. market has become a milestone battle in the war against abortion following the Dobbs v. Jackson Women’s Health Organization Supreme Court case in 2022. While many Republican lawmakers have stayed quiet about the lawsuit and its potential outcomes, 69 pro-life members of Congress filed an amicus brief in the case this week urging the Fifth Circuit to uphold the Texas federal judge’s ruling revoking FDA approval.

According to Mary Szoch, Family Research Council’s director of the Center for Human Dignity, the Court of Appeals’ ruling marks a significant incremental victory for the pro-life cause. “While the Fifth Circuit’s initial ruling doesn’t completely protect women and girls and their unborn children from the dangers of chemical abortion, it is a step in the right direction,” Szoch told The Washington Stand. “Protecting unborn babies after seven weeks gestation will save the lives of both babies and their mothers. Recognizing that federal law protects women and girls from receiving dangerous chemical abortion drugs in the mail will also save lives.”

Szoch concluded, “We are grateful that the Fifth Circuit recognized that these dangerous drugs have the capacity to kill women and girls. We hope for the day when the abortion industry recognizes this truth as well and stops trying to exploit women.”