Doctors Sue FDA Over Loosened Safety Regulations for Chemical Abortions


Americans should be alarmed by the current administration’s aggressive attempts to roll back pro-life protections for women and children while ignoring the various dangers associated with chemical abortion — which accounted for 642,700 abortions in 2023, the first full year after the Dobbs decision.   

This trend is not only ethically disturbing but highly troubling from a medical perspective. Thankfully, a group of doctors and medical associations has sued the FDA for its hasty decision to lift safety regulations related to chemical abortion drugs in one of the first cases since the Supreme Court overturned Roe v. Wade. The court is expected to release a decision in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine this summer. 

And despite the argument by some that the plaintiffs lack standing — which is no surprise given the no-holds-barred approach to abortion-on-demand from the media and the current administration — there are compelling reasons for the court to hear them out. 

Unable to get the FDA’s attention with citizen petitions sounding the alarm on the increasing dangers to women of chemical abortion drugs, four national medical associations and four individual doctors experienced in caring for pregnant and post-abortive patients sued the FDA. Federal district court Judge Matthew Kacsmaryk agreed with the doctors, ruling that when the FDA eased requirements for prescribing the drugs, its actions were unlawful under the Administrative Procedure Act. This ruling was subsequently affirmed by a panel of the Fifth Circuit Court of Appeals.

Predictably, the administration petitioned the Supreme Court for review. Its main claim is that the court should not even consider the merits of the case and throw it out because the plaintiffs lack standing — the legal right to sue in federal court.   

How convenient.  

Declarations submitted by the doctors and medical associations attest that, as a result of the loosening of guidelines, many more women and girls accessing this drug are suffering complications, often ending up in the emergency room. These doctors “feel complicit in an elective chemical abortion” when treating women suffering from acute complications.

Removal of necessary safeguards for women and girls who use chemical abortion drugs, they explain, “place physicians in higher-risk situations with less critical information about patients, thus increasing their exposure to allegations of malpractice and potential liability.”

They add, and this is crucial, that “with the increase in women and girls suffering emergency complications from chemical abortion or seeking to reverse the effects of the chemical abortion regimen, there is a direct correlation in the decrease in time, attention, and resources that emergency department doctors have to treat their other patients.”  

During oral argument, U.S. Solicitor General Elizabeth Prelogar tried to narrow the doctors’ declarations to a mere crisis of conscience that could easily be remedied by asking the hospital to allow them to opt-out of caring for a woman who is suffering complications related to medical abortion. “It’s speculative that any of those women would seek care from the two specific doctors who asserted conscience injuries,” she said. “And even if that happened, federal conscience protections would guard against the injury the doctors face.”

But the last thing these doctors want is to see women suffer complications of a chemical abortion. The even stronger conscience-based objection they make, and Prelogar ignores, is that because of the FDA’s action, an ever-increasing number of women are now unduly placed in harm’s way. 

Justice Clarence Thomas, whose questioning during oral argument is notably brief and always to the point, wasn’t willing to play along. He asked Prelogar, “Could you give us an example of who would have standing … to challenge these FDA actions?” Instead of answering the question, Prelogar argued that the doctors challenging the FDA “stand at a far distance from the upstream regulatory action they’re challenging.” 

Justice Samuel Alito, author of the court’s opinion in Dobbs, was not satisfied with this response. He followed up by asking, “Is there anybody who could challenge in court the lawfulness of what the FDA did here?” Prelogar responded: “In this particular case, I think the answer is no.” Even Chief Justice John Roberts, citing the “remote nature of the injury” and “small number of adverse effects,” followed up with a chilling question: “What percentage of adverse consequences would be enough? What percentage of emergency room visits would be enough?”  

It is ironic that for years, Big Abortion challenged the constitutionality of abortion restrictions on behalf of prospective clients but now argues that doctors caring for patients with abortion-related complications can’t complain. In addition to speaking on behalf of their future patients, the doctors and medical groups challenging the FDA’s erasing of safety guidelines clearly satisfy standing requirements, not only because they are made involuntarily “complicit in abortion,” but also because their attention to other patients is taxed by the onslaught of medical emergencies afflicting women undergoing chemical abortions. 

Judicial review of the FDA’s grossly irresponsible erasure of standards for chemical abortion is urgently needed. Otherwise, we’re betraying the growing number of vulnerable pregnant women and the principled doctors who are treating them when these “safe and effective” treatments go horribly wrong. 

Andrea Picciotti-Bayer
Andrea Picciotti-Bayer
Andrea Picciotti-Bayer is Director of the Conscience Project. A Stanford-educated lawyer, she has dedicated her legal career to civil rights and appellate advocacy. Andrea appears frequently in the media to discuss religious freedom controversies and legal victories. Her writing has been featured in the Wall Street Journal, National Review, Fox News, Newsweek, CNN en Español and other publications.

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