March 27, 2024

Mifepristone

The Supreme Court on Tuesday signaled that it was likely to allow mifepristone, one of two drugs used in medication abortions, to remain widely available in the United States. During roughly 90 minutes of oral arguments, a majority of the justices appeared ready to throw out the dispute over the FDA’s expansion of access to the drug in 2016 and 2021 because the challengers in the case – several individual doctors and groups of doctors who are opposed to abortion on religious or moral grounds – do not have a legal right to sue, known as standing…

“The case began in November 2022, when several individual doctors and groups made up of doctors opposed to abortion went to federal court in Texas. They challenged both the FDA’s initial approval of mifepristone in 2000 and a series of decisions by the FDA in 2016 and 2021 that expanded access to the drug… The U.S. Court of Appeals for the 5th Circuit ruled that the challenge to the initial approval of the drug had come too late. But it rolled back the FDA’s 2016 and 2021 decisions.” SCOTUSblog

Here’s our prior coverage of the case. The Flip Side

See past issues

From the Left

The left argues that the lawsuit should fail on standing concerns and also that mifepristone is safe.

“[The plaintiffs] are a group of anti-abortion physicians who do not prescribe mifepristone. Rather, they worry that someday, some patient who has taken mifepristone prescribed by a different doctor might have serious adverse complications and end up in their care—forcing them to be ‘complicit’ in abortion simply by treating the patient…

“These physicians claim that the only solution to their speculative fear is a nationwide ban on mifepristone, achieved through a judicial order that revokes the FDA’s approval of the drug for everyone…

“In a saner judiciary, the case would have been booted out of the courthouse with prejudice, because the plaintiffs have neither sustained nor suffered an injury: They are merely speculating about the possibility of a future harm, which does not establish standing under Article 3 of the Constitution. And that possibility really is quite remote, since mifepristone has been proved safe in more than 100 scientific studies.”

Dahlia Lithwick And Mark Joseph Stern, Slate

“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…

“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.”

Editorial Board, Washington Post

“Several justices pointed out that doctors who object to participating in an abortion can already abstain under separate conscience exceptions in federal law, which led to the obvious follow-up of why they are seeking a sweeping ban when the doctors can simply opt out…

“Why wouldn’t the remedy in this situation be to ensure doctors like the ones bringing the suit do not participate in abortion care, rather than stopping all women throughout the country from taking mifepristone?”

Pema Levy, Mother Jones

From the Right

The right is critical of the FDA’s 2016 and 2021 expansions, arguing that they endanger women.

The right is critical of the FDA’s 2016 and 2021 expansions, arguing that they endanger women.

“In 2016 the FDA allowed nonphysicians to prescribe mifepristone and removed the requirement that the prescriber see patients for follow-up visits to evaluate them for potential complications, making it far less likely that an ectopic pregnancy would be diagnosed before it became life-threatening. In 2021 the agency eliminated the requirement that women be evaluated in person by any medical professional…

“An ectopic pregnancy—when an embryo implants outside the uterus—is fatal for the baby and can threaten the mother’s life if it isn’t swiftly treated. It is the leading cause of maternal death in the first trimester… Given that the FDA warns of this risk in the drug label, its changes in protocol were arbitrary and capricious—the legal standard the Fifth Circuit applied in ruling against the agency. The justices should uphold that decision.”

Christina Francis, Wall Street Journal

“A woman who thinks she is nine weeks pregnant can easily be eleven weeks pregnant, and this has major implications in a chemical-abortion situation. Without ultrasound and physician oversight, she will be prescribed mifepristone based on her mistaken dates, and her fetus will be well beyond the FDA’s ten-week limit, resulting in a far riskier and more traumatic abortion

“[Studies show] that if a chemical abortion happened after 84 days of gestation, 38.5 percent of those women required follow-up surgery and 4 percent sustained significant infection. In fact, all the original studies the FDA used to establish the REMS included an ultrasound in the protocol to properly date the pregnancies…

“We know mifepristone is not, as is widely and wrongly reported: ‘safer than Tylenol.’ How could it be, if up to 4.6 percent of women have to visit the emergency room after taking it?”

Grazie Pozo Christie, National Review

Some argue that, “Merits aside, the threshold question for the Court is whether the doctors have legal standing to sue, which requires a concrete injury that is traceable to a defendant’s actions… How does letting a nurse practitioner rather than a doctor dispense the pill increase the likelihood that a woman will need emergency care? The risks of injury that plaintiffs claim they would suffer are speculative…

“The pro-life doctors’ arguments for standing would eviscerate any limiting principle… Agencies often don’t have ‘perfect empirical or statistical data,’ and the APA ‘imposes no general obligation on agencies to conduct or commission’ their own studies. Yet that is essentially what the plaintiffs want the Court to force the FDA to do.”

Editorial Board, Wall Street Journal

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