The court agreed to hear FDA v. Alliance for Hippocratic Medicine after two panels of judges on the U.S. Court of Appeals for the 5th Circuit ruled to impose significant restrictions on health providers prescribing mifepristone — the first part of the two-drug regimen used in more than half of all abortions in the United States. Whether patients can access mifepristone at all isn’t at stake; courts have agreed that the statute of limitations is up to challenge the FDA’s 2000 approval of the drug. But when and how they can do so is still challengeable: The 5th Circuit nixed changes the agency made in the past eight years that made it possible for women to obtain mifepristone more easily — later on in their pregnancies, for example, or by mail or without three separate visits to health facilities.
The Supreme Court must now consider whether to side with the 5th Circuit judges or with the doctors and scientists at the FDA on a subject about which judges generally know little and doctors and scientists a lot. But before the justices even reach that debate, they must settle another: Does the litigant in this case even have standing, the legal right to sue? Resolving this question is simpler than it sounds.
To have standing, the Alliance for Hippocratic Medicine must show existing or imminently impending injury caused by the broader availability of mifepristone. Yet they, emergency room doctors, neither use nor prescribe mifepristone. So they’ve settled on claiming hypothetical injury: If some unspecified member of their group has to treat patients who have taken mifepristone, that member could suffer harm. It should be no great harm to doctors, who have sworn to care for those in need, to treat those suffering side effects from any duly prescribed medication.
The speculative injury the Alliance for Hippocratic Medicine claims is even more dubious considering complications from mifepristone are exceedingly rare. For this same reason, the plaintiffs’ case is weak — even if the Supreme Court does decide that they have standing to challenge the FDA. The 5th Circuit, agreeing in part with U.S. District Judge Matthew Kacsmaryk, said the FDA violated crucial safeguards when it loosened regulations on mifepristone. The FDA says it has merely updated the approved conditions of use for a drug deemed safe and effective for almost a quarter century, and for millions of patients.
The science, unsurprisingly, is on the scientists’ side. Study upon study has shown that fewer than 1 percent of mifepristone patients need hospitalization. The FDA has received reports of 28 deaths out of the 5.6 million who have used the drug between its 2000 approval and last summer, and even these can’t be confidently attributed to the drug. The rest of the world has been engaged in similarly rigorous research and has come to the same conclusion. At least 94 countries have approved the pill, and increasingly they’re putting it on their essential medication lists.
Indeed, patients seeking abortions are in more danger without mifepristone than with it. Terminating a pregnancy with mifepristone’s usual companion pill, misoprostol, is possible — but results in more cramping and bleeding. The risk of severe complication from childbirth, meanwhile, hovers around 1.4 percent, according to the Centers for Disease Control and Prevention.
Compare the methodology underlying these conclusions, established by the global community carefully and over ample time, to the methods Judge Kacsmaryk relied on in his ruling that the 5th Circuit reviewed: Much of his data came from an antiabortion group whose very mission is to undermine the FDA’s policy. To prove that “chemical abortion” provokes a “negative change” in patients, he cited a study that relied on a collection of anonymous blog posts from — yes, really — abortionchangesyou.org.
The Supreme Court pronounced less than two years ago that courts have little business meddling in democratically decided abortion rules. Now, its justices are asked to decide whether courts have any business overruling the scientific judgment of an executive agency — and, in so doing, curb patients’ ability to access mifepristone regardless of their states’ laws. The answer should be obvious.
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