The Supreme Court will hear oral arguments Tuesday on the U.S. Food and Drug Administration’s (FDA) sweeping deregulation of chemical abortion in 2016 and 2021. A coalition of doctors convinced “all six judges that have opined on the merits of this case” (FDA v. Alliance for Hippocratic Medicine) that “FDA’s 2016 Major Changes and 2021 actions were unlawful,” according to the respondents’ (the alliance of doctors) brief.
FDA Changes
When the FDA first approved chemical abortion in 2000, it required, among other safeguards, that the drugs must be “be dispensed in person by or under the supervision of a doctor,” petitioners (the FDA) acknowledged. Respondents noted that chemical abortion’s approval was conditioned upon these safeguards “because the drug could not safely be approved without restrictions.”
“These pills take the life of a child every single time,” Senator James Lankford (R-Okla.) told The Washington Stand, “but it can also take the life of the mom or cause major side effects.”
However, in 2016, the FDA announced “major” changes to deregulate the abortion pill. Respondents pointed out that these changes were made “at Danco’s request.” Danco is the pharmaceutical company which manufactures abortion pills and was party to a separate lawsuit, which the courts consolidated with this one.
In the 2016 revisions, the FDA made 10 changes to the administration of chemical abortions. These changes included:
- “Increasing the maximum gestational age from seven weeks to ten,”
- “Allowing nondoctors to prescribe and administer chemical abortions,”
- “Removing the Day 3 in-person administration requirement for misoprostol,”
- “Eliminating the Day 14 in-person follow-up examination to identify complications,” and
- “Removing the requirement that prescribers report non-fatal adverse events.”
“In 2016, FDA stripped away many safeguards, failing to explain why it was proper to eliminate them all without a study showing their cumulative safety,” Respondents argued. “In 2021, FDA removed the last-remaining doctor’s visit, allowing mail-order chemical abortions despite admitting the safety studies on which it relied were ‘insufficient.’”
Procedural History
The coalition of doctors challenged these chemical abortion rule changes in 2022, as well as the FDA’s initial approval in 2000 and a few other administrative actions. The district court ruled against the FDA on all counts, holding that their actions were “arbitrary and capricious” and declaring a “stay” against their approval of chemical abortion pills.
On appeal, a panel of the U.S. Court of Appeals for the Fifth Circuit ruled that it was too late to challenge the initial approval of chemical abortion in 2000 but they upheld the district court’s ruling against the FDA’s more recent actions. The FDA and Danco then appealed to the Supreme Court, which temporarily put the district court’s order on hold without writing an opinion.
However, “after further briefing and argument” at the Fifth Circuit, that appellate court again suspended the FDA’s 2016 and 2021 actions, leading to another appeal to the Supreme Court. The Supreme Court will hear arguments Tuesday on three questions, respectively reviewing 1) standing, 2) the FDA’s actions, and 3) the district court’s order.
Chemical Abortion Context
The chemical abortion method has expanded rapidly in recent years to the point that, “today, more than half of American women who … terminate their pregnancies rely on mifepristone to do so,” as the petitioners’ brief put it.
The expansion of chemical abortion “was actually prior to” and “unrelated to Dobbs,” Lankford explained, but rather was due to “its being promoted online,” “its accessibility,” and “the fact that individuals can receive these drugs to do it at home.”
However, the Biden administration has worked to aggressively expand chemical abortion in the aftermath of Dobbs, acknowledged Lankford, who has pressured the Biden administration and pharmacies over chemical abortion. “What the Biden administration is doing is saying, ‘We want to get these chemical drugs to as many people as we possibly can. Even if they’re in states that do not allow abortion, we still want to be able to go around the state laws.’”
Dangers of Chemical Abortion
Besides circumventing state laws, the FDA is also omitting critical safety checks, Lankford argued. As evidenced by the drug’s conditional approval in 2000, “there are serious issues” with mifepristone “that just require a basic doctor check-in, just a basic sonogram,” he said. For instance, he said with an ectopic pregnancy or incorrect estimate of gestational age, a woman taking chemical abortion pills can wind up with severe complications or possibly even die.
“The FDA’s own label for mifepristone and misoprostol says that roughly one in 25 women who take the drug will end up in the emergency room,” warned Alliance Defending Freedom lawyer Erin Hawley, who represents the doctors’ coalition.
“If you take this pill, and you have an ectopic pregnancy, you’re going to really have a lot of hemorrhaging, and you’re going to end up in the emergency room. And if you don’t get there fast enough, it could take your life,” warned Lankford. This is one reason to require women to have an in-person visit with a doctor before commencing a chemical abortion, he argued. “If you don’t ever see a doctor, you can’t determine if you have an ectopic pregnancy.”
Additionally, “we need to know how far along the woman is,” Lankford said. The FDA previously approved mifepristone for a maximum gestational age of seven weeks, extended to 10 weeks in 2016, beyond which the drug is deemed unsafe for the mother. Beyond this point, the unborn baby grows rapidly, increasing the risk of severe complications. “If she miscounts the number of weeks she is pregnant, and she is actually farther along than she thought, then there’s a dramatic increase in the side effects, and … it could lead to death for her,” stated Lankford.
Lankford also objected to the FDA changing the rules to no longer require the reporting of adverse effects unless they are fatal. Such adverse effects could include severe bleeding, requiring an emergency room visit or a blood transfusion. “It is undisputed that complications result in emergency room visits for 2.9%–4.6% of women,” the respondents’ brief noted.
The FDA is charged with approving drugs that are safe and effective, its brief acknowledged, but with this change it is willfully ignoring evidence that chemical abortion drugs are not safe, Lankford argued. “It allows the Biden administration, the FDA, to say, ‘We don’t have any record of any bad side effects from this,’ when really what FDA is saying is, ‘Don’t tell us if there are any side effects unless she dies,’” he said.
“The challenge seems to be right now for the Biden administration is, how can they get abortions into states that don’t allow surgical abortions?” stated Lankford. “They’re looking for ways to say, ‘We’ll just mail you an abortion kit, and you can do it at home. And we’re not going to tell you about the possible side effects. We’re not going to tell you about the risks. In fact, we don’t even track those things.’”
“The focus of this administration has been very strong into increasing the number of abortions in America,” Lankford observed. “Whereas the past administrations — Republican and Democrat — were talking about decreasing the number of abortions, this administration is literally the opposite of that. … That’s ghastly in a million ways, but especially when it puts people at risk.”
Joshua Arnold is a senior writer at The Washington Stand.
