Appeals court puts a halt on FDA’s actions endangering the lives of pregnant women seeking access to abortion pill

In a significant win for women’s health, the U.S. Court of Appeals for the Fifth Circuit made a ruling on August 16 in the case of Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The ruling states that the FDA must reinstate crucial safeguards for chemical abortion drugs and put an end to illegal mail-order abortions. Although the case is currently on hold until the Supreme Court decides whether to hear it, this ruling marks an important step in protecting women from the dangers of chemical abortion.

Chemical abortions not only end the life of an unborn child but also pose serious health risks to women. As stated by the court, the FDA’s own data demonstrates that “thousands of women, and potentially hundreds of thousands, have experienced serious adverse effects as a result of taking the drug, requiring surgery or emergency care to address these effects.”

The most recent medication guide reveals that between 2.9% and 4.6% of women end up visiting the emergency room after taking chemical abortion drugs.

FEDERAL APPEALS COURT RESTRICTS ACCESS TO ABORTION PILL MIFEPRISTONE, BUT THE DRUG REMAINS AVAILABLE

However, despite initially approving chemical abortion drugs in 2000 under a regulation that required the FDA to acknowledge pregnancy as a serious or life-threatening illness, the FDA later removed all meaningful safeguards.

For instance, in 2016, the FDA extended the permissible age for chemical abortion from seven to 10 weeks of gestation, removed two out of three required office visits, allowed non-doctors to prescribe the drug regimen, and eliminated the reporting of non-fatal adverse events to the FDA Adverse Event Reporting System.

Then, in 2021, the FDA completely eliminated the requirement for office visits, allowing chemical abortion drugs to be shipped via mail without any examination by a healthcare professional.

This means that there is no opportunity for doctors to diagnose ectopic pregnancies, which occur in one out of every 50 pregnancies and are contraindicated for chemical abortion. Ectopic pregnancies can result in hemorrhaging and even death.

In its decision, the Fifth Circuit reminded the FDA that it must comply with the Administrative Procedure Act (APA). According to this congressional enactment, agencies must, at the very least, consider important aspects of the problem they are addressing and provide an explanation that is supported by evidence.

In the opinion of the Fifth Circuit, the FDA failed to do both when it removed crucial safeguards from chemical abortion. The court stated that “by loosening the safety restrictions of mifepristone, the FDA failed to address several important concerns regarding the drug’s safety for women who use it.”

In particular, the FDA “did not consider the cumulative effect of removing multiple important safeguards at the same time. The agency did not assess whether these significant and interconnected changes might alter the risk profile in a way that would necessitate continued reporting of non-fatal adverse events. Furthermore, the agency failed to gather evidence affirmatively demonstrating that mifepristone could be used safely without the need for in-person prescription and dispensation.”

This means that there is no opportunity for doctors to diagnose an ectopic pregnancy, which occurs in one out of every 50 pregnancies and is contraindicated for chemical abortion, potentially resulting in hemorrhaging and even death.

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Regarding the 2021 decision to permit mail-order abortion, the court criticized the FDA for relying solely on adverse-event data in FAERS after eliminating the requirement for providers to report such events. The court stated that it is “unreasonable” for an agency to eliminate reporting requirements for chemical abortion and then use the resulting lack of data to support its decision.

The court’s ruling reinstates these crucial safeguards and reverts chemical abortion back to the original 2000 regulations, including the limitation of seven weeks of gestation, mandatory office visits, reporting of non-fatal adverse events, and physician dispensation. Additionally, these dangerous drugs can no longer be shipped via mail.

This ruling serves as a victory for the group of courageous doctors who are experienced in caring for pregnant and post-abortive women. These doctors have been plaintiffs in the case and have advocated for the well-being of girls and women for years.

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For decades, these doctors have brought attention to the serious risks and complications associated with chemical abortion. They have petitioned the FDA to remove chemical abortion drugs from the market or, at the very least, reinstate necessary safeguards.

Now, thanks to the Fifth Circuit’s ruling, the FDA will finally be held accountable for its disregard of the law and women’s health and safety.

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