Reining in the FDA

Last week, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, the U.S. Court of Appeals for the 5th Circuit found unlawful the Biden administration’s mail-order drug regimen and held that the FDA must restore important safeguards on chemical abortion drugs. While the ruling will not go into effect until the Supreme Court decides whether to review the case, the unanimous decision is a victory for women’s health and the rule of law.

First, the court’s action is victory for women’s health. The court concluded that the so-called abortion pill—a form of chemical abortion—can be dangerous. Indeed, it has harmed thousands, if not hundreds of thousands, of women. The complication rate for chemical abortion drugs is four times higher than for surgical abortions. And even the FDA’s own research shows that between 2.9 percent to 4.6 percent of women who undergo this drug regimen end up in the emergency room. Women win when the federal government values their health and safety above politics and recognizes the dangers of chemical abortion.

The decision restores crucial safety guardrails on chemical abortion—eliminating the FDA’s unlawful mail-order abortion regime and ensuring that a doctor actually sees a woman before she receives the dangerous drug. This decision is not only crucial for protecting women’s health but restores the promise of Dobbs that the people’s representatives may enact laws regulating abortion and protecting life. It ensures that states like my home state of Missouri may protect unborn children and women from chemical abortion drugs and thwarts the Biden administration’s plan to make chemical abortion available regardless of state law. The decision also reinstates crucial health safeguards original to the approval of chemical abortion in 2000, including the seven weeks’ gestational limitation, necessary office visits, non-fatal adverse event reporting, and physician dispensation.

Second, the victory for the rule of law: The court faulted the FDA for cutting numerous corners when it removed these crucial safeguards from the chemical abortion drug regimen. That is unlawful.

The Administrative Procedure Act was enacted by Congress to ensure that federal agencies like the FDA are held accountable. The Act’s fairly minimal requirements ensure that agency action is consistent with the law and not arbitrary or capricious. This means that an agency must engage in reasoned decision making. It may not ignore important aspects of a problem or issue a decision contrary to the evidence before it.

Yet in 2016, the agency stripped away numerous safeguards including extending the gestational age of the baby from seven to ten weeks’ gestation, removing the office visit to dispense the second drug in the regimen, as well as the follow-up visit to diagnose and treat complications, allowing non-doctors to prescribe the drugs, and eliminating the requirement that providers report non-fatal adverse events to the FDA Adverse Event Reporting System.

In doing so, the 5th Circuit found that the “FDA failed to address several important concerns about whether the drug would be safe for the women who use it.” For instance, the agency “failed to consider the cumulative effect of removing several important safeguards at the same time.” It also failed to consider whether changes it admitted were “‘major’ and ‘interrelated’” might alter the drug’s risk profile, so that the FDA should continue to require reporting of non-fatal adverse events. And to add insult to injury, the agency “failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”

With respect to the 2021 decision to allow mail-order abortion, the court criticized the FDA for giving dispositive weight to the adverse-event data in FAERS after eliminating that very same provider-reporting requirement in 2016. As the prior 5th Circuit panel put it: it’s “unreasonable” for an agency to get rid of a reporting requirement and then “use the resulting absence of data to support its decision.” To compound its error, the agency also relied on studies that it admitted did not support its decision to allow mail-order abortion.

Women and girls deserve the very best our country can give them. It’s high time the federal government—and that includes the FDA—recognizes that their health and wellbeing matters more than a political ideology or padding the coffers of abortion providers and drug manufacturers. It’s time to hold the FDA to the rule of law.

—Erin Hawley argued before the U.S. Court of Appeals for the 5th Circuit in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.