Abortion is back at the supreme court: what is the mifepristone case about?
The supreme court has taken up a challenge to a federal appeals court ruling to curtail access to mifepristone, a key abortion pill.
A decision from the nation’s highest court in the case will likely arrive by summer 2024, months ahead of the presidential election and two years after the court’s 6-3 conservative majority overturned Roe v Wade, eradicating the national right to abortion and plunging US abortion access into chaos.
Mifepristone is one of two pills typically used in US medication abortions, which make up more than half of recent abortions in the United States. Late last year, a group of anti-abortion organizations and doctors sued the FDA, accusing it of overstepping its authority when it approved mifepristone in 2000. That case triggered several months of litigation and ultimately led to the supreme court’s decision on Wednesday to weigh in.
The pill remains on the market for now, but abortion rights experts say the tumult around abortion laws has led to “chaos and confusion” for patients and healthcare providers.
What is mifepristone?
In the US healthcare system, a patient typically takes two drugs, mifepristone and misoprostol, several hours apart in order to induce a medication abortion. While mifepristone generally stops a pregnancy from progressing, misoprostol makes the uterus cramp, bleed and empty out – similar to a miscarriage. Medication abortions, which make up more than half of US abortions, are usually performed within the first trimester of pregnancy.
Although the plaintiffs claim that mifepristone is unsafe or understudied, a New York Times analysis found that more than 100 studies conducted across three decades and more than two dozen countries has found that mifepristone is safe to use.
“Medical organizations across the board agree that this medication, mifepristone, is like the first-line treatment that we should give for people that are managing miscarriages, that are ending pregnancies for a lot of different reasons,” said Kristyn Brandi, the board chair of the group Physicians for Reproductive Health and a New Jersey OB-GYN.
Where is mifepristone legal?
Abortion pills generally remain legal wherever abortions are still allowed. Alabama, Arkansas, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas and West Virginia all have sweeping abortion bans that outlaw the procedure in almost all circumstances. (Wisconsin also has a 19th-century law on the books that some have interpreted to ban abortion, but a number of abortion providers have now resumed working there.)
Georgia, South Carolina, Nebraska, North Carolina, Arizona, Florida and Utah ban abortion at some point before viability, or the point where a fetus can survive outside the womb, which is generally pegged at about 24 weeks of pregnancy. Before Roe fell, it blocked states from implementing pre-viability abortion bans.
However, several states that do permit abortion have restricted the use of medication abortion. States like Kansas and Michigan say that medication abortions can only be provided by a physician. Arizona, which bans abortion past 15 weeks of pregnancy, also bans mailing abortion pills.
The Department of Justice, however, has said that it remains legal under federal law to mail abortion pills.
“Everyone should know that mifepristone remains FDA-approved, and medication abortion remains safe and effective,” said Kelly Baden, vice-president for public policy at the Guttmacher Institute.
How did the case come about?
The Alliance for Hippocratic Medicine, the association that originally accused the FDA of improperly approving mifepristone, includes several doctors who say they have treated people who have had complications from medication abortions. They’re being represented by the Alliance Defending Freedom, a powerhouse Christian law firm that has devoted itself to championing conservative causes like ending abortion rights.
The ADF filed the case in federal court in Amarillo, Texas, which guaranteed that only one judge would oversee it: US district judge Matthew Kacsmaryk, a conservative appointed by the former president Donald Trump. In April, Kacsmaryk ruled to suspend the FDA’s approval of mifepristone, peppering his decision with controversial rhetoric widely used by the anti-abortion movement, like calling fetuses “unborn humans” and claiming that women who get abortions “often” feel shame and depression. (A landmark study of nearly 1,000 women who had abortions found that, five years after the procedure, 95% of women say it was the right decision.)
In August, the conservative fifth circuit court of appeals narrowed Kacsmaryk’s ruling, deciding that, while it was too late to completely suspend the FDA’s approval of mifepristone, it was not too late to reverse more recent changes that the FDA has made in its regulation of the drug. If the appeals court ruling is upheld, it would block mifepristone from being dispensed through telemedicine, stop non-physicians from prescribing it, and tell physicians that mifepristone should be used only up until seven weeks of pregnancy.
The Alliance for Hippocratic Medicine, the Biden administration and Danco Laboratories, a manufacturer of mifepristone, all asked the supreme court to step in. The Alliance petition asked the supreme court to overturn the FDA’s 2000 approval of mifepristone, while the Biden administration and Danco’s petitions asked the supreme court to focus on the narrower appeals ruling rolling back the FDA’s later changes relaxing the regulation of mifepristone.
The supreme court on Wednesday agreed to consolidate and hear arguments in the Biden administration and Danco’s legal petitions, but rejected the Alliance’s petition. That suggests that the FDA’s original approval of mifepristone will remain intact, leaving the pill on the market in some form.
“We know it’s safe and effective,” said Brandi. “The data hasn’t changed, but whether or not the legality of the medication changes is a different thing.”
What does this case mean for other FDA-approved drugs?
If changes to mifepristone are allowed to take effect, this would be the first time a federal court has ever rewritten the FDA’s approvals process. That could open a Pandora’s box for both pharmaceutical companies and the supreme court, since any drug’s FDA approval could be called into question.
“If you’re Brett Kavanaugh, the question you have to be asking yourself is, ‘Do I want to be in the business of reviewing a lot of controversial drug approvals? Do I want to hear the case about Covid vaccines and [the HIV prevention medication] PrEP?’” said Mary Ziegler, a University of California, Davis School of Law professor who studies the legal history of reproduction.
What happens now?
A date for oral arguments has not yet been set in the supreme court case. Mifepristone will remain available until there’s a final order in the case.
If access to mifepristone is curtailed, several abortion clinics have already publicly said that they will pivot to provide misoprostol-only abortions. Although it’s also extremely safe, misoprostol alone is less effective than the two-drug medicaion abortion protocol and can cause more side effects.
Mifepristone will also likely to continue to flow through the US through the underground markets now helping people induce their own abortions, in a practice known as “self-managed” abortions. Medical experts widely agree that self-managing an abortion using pills early in pregnancy can be safe.
Regardless, the “legal whiplash” around abortion access since the supreme court overturned Roe v Wade has been especially harmful for patients seeking the procedure , said Baden, of Guttmacher.
“It’s wildly confusing for people who might need abortions, people who have abortion appointments right now, to yet again have another major news headline that kind of throws more chaos into an already confusing legal landscape and situation,” Baden said.