FDA’s Removal of Safeguards on Abortion Drugs Placed Women in Danger

The federal agency responsible for ensuring the safety of our food and drugs made a decision impacting hundreds of thousands of Americans based on studies it conceded were “not adequate.” Yet the U.S. Food and Drug Administration (FDA) plowed ahead anyway, pushing the use of mifepristone, a high-risk drug. That’s why the U.S. Supreme Court will hear oral arguments in a lawsuit against the agency later today.

The FDA’s drug label warns that roughly one in 25 women will end up in the emergency room after taking mifepristone. For that reason, the FDA initially required women seeking this abortion drug (taken as part of a protocol that includes another drug, misoprostol) to receive in-person care with a licensed physician: once before taking the drugs to check for life-threatening conditions like an ectopic pregnancy, and then two follow-up appointments to check for serious complications, including severe bleeding and life-threatening infections. These were common-sense, basic safety standards.

In 2016 and again in 2021, however, the FDA permanently eliminated its requirements that women receive ongoing in-person medical care when taking mifepristone, even though the drug comes with a Black Box warning noting it can cause “serious and sometimes fatal infections and bleeding.” The agency concluded in its 2021 decision that even the initial visit between a woman and a health care professional was “no longer necessary.” It based this decision on data and published studies it admitted were unreliable and inadequate.

The FDA relied on its Adverse Event Reporting System (FAERS) database to “conclud[e] that there d[id] not appear to be a difference” in adverse events when the in-person requirement had not been enforced. But this contradicts the agency’s official position that “the FAERS data by themselves are not an indicator of the safety profile of the drug” and that the “number of suspected reactions in FAERS should not be used to determine the likelihood of a side effect occurring.”

What’s more, the FDA did not acknowledge its 2016 decision to eliminate the requirement that prescribers report all non-fatal serious adverse events, leaving only the drug manufacturers to report these complications. How, one might wonder, would far-removed manufacturers learn about adverse events from OB-GYNs and emergency room doctors who are under no obligation to report? The FDA provides no answer to this fatal flaw in the data.

The agency also claimed support for its decision to eliminate in-person care from published literature evaluating mail-order dispensing of abortion drugs. But even the FDA admitted those studies suffered from serious limitations and raised red flags.

For example, one study showed an alarming rate of women needing hospitalization, which the FDA disregarded. Some studies were limited in their usefulness, often because of the lack of follow-up information, and some were largely irrelevant because they had evaluated outcomes for dispensing abortion drugs “after in-person clinical assessment.”

Most troubling, other studies the FDA cited revealed that participants had a significantly higher number of “unplanned clinical encounters,” and, in one, the “telemedicine plus mail group” had emergency department visits at a rate almost three times higher than “the in-person group.”

All this led the FDA to concede that “the studies [it] reviewed are not adequate on their own to establish the safety of the model of dispensing mifepristone by mail.” The agency also acknowledged that “the literature suggests there may be more frequent [emergency department]/urgent care visits related to the use of mifepristone when dispensed by mail.”

When the FDA relies on studies to remove critical drug safety standards, one would expect those studies to support its decision. Yet, in this case, they did not. But the FDA still authorized women and young girls to self-administer abortions at home or in a dorm room, leaving them at greater risk for serious and life-threatening complications.

Indeed, the FDA failed to engage in the reasoned decision-making the Administrative Procedure Act requires and American women deserve.

Not everyone thinks the FDA should be able to get away with jeopardizing women’s health. Alliance Defending Freedom attorneys, including me, helped doctors, medical associations, and their members—who are witnessing firsthand the harms inflicted by the agency’s recklessness and are regularly called upon to treat emergencies caused by abortion-drug complications—file the lawsuit challenging the FDA that has now reached the Supreme Court.

These doctors are perfectly positioned to challenge the FDA’s actions. In an unprecedented agency action, the FDA conscripted OB-GYN hospitalists, emergency room doctors, and on-call OB-GYNs to help fix the problems the agency created. From the beginning, the FDA identified emergency medical care as the backstop for expected abortion-drug complications.

No agency is above the law. We are urging the Supreme Court to hold the FDA accountable. The American people deserve a federal government that engages in reasoned decision-making, especially when removing common-sense health and safety standards. The FDA cannot be allowed to harm women with its pre-drawn conclusions and insufficient rationales.

Erin Hawley is senior counsel and vice president of the Center for Life and regulatory practice at Alliance Defending Freedom (@ADFLegal). She will argue before the Supreme Court on March 26 in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine.

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