Supreme Court action on mifepristone demonstrates abortion care is all about the courtroom

(CNN) — The Supreme Court’s acceptance of an appeal from the Biden administration on Wednesday opens a new front in the national controversy over access to abortion as states, including Texas, have been moving aggressively against women since the high court overturned Roe v. Wade last year.

Fourteen states have outright forbidden abortion and many others have significantly restricted when a pregnancy can be terminated since the June 2022 decision.

Texas, which bans it, also recently blocked a woman from aborting a fetus diagnosed with a fatal genetic condition, even though physicians said continuing the pregnancy could threaten her life and future fertility. (Lawyers for the woman, who was 21 weeks pregnant, said she had already left the state to seek the procedure elsewhere.)

More broadly, these cases demonstrate the new post-Roe world created by the Supreme Court.

The most personal choices of women (with their physicians) are now litigated in courtrooms, alongside new policy dilemmas, such as over government’s approval of mifepristone. Another pending federal dispute tests whether a near total abortion ban (in Idaho) is preempted by a US law that requires hospitals receiving Medicare reimbursement to provide emergency care for needy patients.

The new case accepted by the high court on Wednesday, Food and Drug Administration v. Alliance for Hippocratic Medicine, will determine abortion access and the power of federal regulators to assess the safety and effectiveness of drugs, whether related to abortion or treatment for cancer, epilepsy and other medical conditions.

The case, expected to be heard this spring with a decision likely by July, is destined to be a flashpoint in the 2024 presidential election and political races nationwide. It marks the first test of the justices’ sentiment on abortion since their 2022 reversal of Roe v. Wade. The 1973 case had been repeatedly upheld until the hard-right coalesced on the court, with the addition of three appointees by former President Donald Trump.

The FDA case will also be the first abortion-related dispute with Justice Ketanji Brown Jackson on the bench. She succeeded Justice Stephen Breyer in 2022. (The Democratic appointees support abortion rights.)

Reverberations from Dobbs v. Jackson Women’s Health Organization remain strong, including in the political sphere, where the consequences have generally given Democratic candidates leverage.

The new controversy at the court differs from Dobbs, which involved the fundamental right to abortion. At issue now are statutory rules that test whether the FDA’s actions regarding the drug’s use were sufficiently grounded in science and medicine.

Mifepristone, first approved by the FDA in 2000, is part of a two-pill protocol that has become the most common method in the US for women seeking to end a pregnancy.

A crucial threshold question for the justices is whether the challengers to the FDA – physicians who oppose abortion and do not prescribe mifepristone – have legal standing to bring the case. Lower federal court judges allowed the lawsuit and then invalidated various FDA rules for the drug’s use. The Supreme Court in late April put a hold on the earlier court action, and mifepristone remains available today.

Biden administration lawyers at the Department of Justice, whose appeal was accepted on Wednesday, argue that those physicians lack standing because they cannot show a concrete injury.

The physician and medical group challengers counter that some women who use medication abortion have complications and seek emergency treatment. The challenging physicians say they would be forced to provide care that violates their consciences and compromises care for their regular patients.

History of the drug

FDA approval of mifepristone goes back 23 years, but two sets of regulations for its use, from 2016 and 2021, are specifically in dispute in the new case. The question is whether those actions were “arbitrary and capricious,” rather than sufficiently justified. The court rejected a petition from the Alliance for Hippocratic Medicine directly challenging the core 2000 approval of the drug.

Before the court will be the 2016 action, when the FDA said the abortion medication could be taken up to ten weeks into a pregnancy, not just seven weeks as had been the gestational age limit. The agency also allowed certain non-physician healthcare providers to prescribe and dispense mifepristone. Five years later, in 2021, FDA dropped the requirement that the medication be dispensed in person, rather than

The Alliance for Hippocratic Medicine is represented by the conservative Christian legal group Alliance Defending Freedom. It filed the initial case in the Texas region covered by US District Judge Matthew Kacsmaryk, known to be sympathetic to the anti-abortion cause.

Kacsmaryk let the lawsuit proceed and said the FDA had failed to evaluate sufficiently the harms of mifepristone. “The Court,” he wrote of his determination last April, “does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns – in violation of its statutory duty – based on plainly unsound reasoning and studies that did not support its conclusions.”

Kacsmaryk wanted to reject FDA determinations back to its 2000 approval of mifepristone. But the 5th US Circuit Court of Appeals found that the deadline for a challenge to the 2000 approval had passed, even as it agreed with much of Kacsmaryk’s decision. The US appellate court similarly accepted the arguments that the FDA’s loosening of requirements since 2016 were not sufficiently supported by expert studies.

In appealing the case to the high court, US Solicitor General Elizabeth Prelogar said those lower court rulings “mark the first time any court has restricted access to an FDA-approved drug based on a disagreement with FDA’s expert judgment about the conditions required to assure that drug’s safe use.”

She said the 5th Circuit decision would severely disrupt the pharmaceutical industry, a position also emphasized by Danco Laboratories, which gained FDA approval for its drug Mifeprex in 2000. Danco separately appealed the 5th Circuit decision. The justices consolidated the cases.

The FDA’s defenders contend that the anti-abortion doctors and groups are not required to prescribe mifepristone and that their fears about emergency room problems are speculative.

As it urged the justices to reject the government’s appeal, the Alliance of Hippocratic Medicine told the court, “FDA has always known that those doctors would be needed to respond to harms caused by chemical abortion,” adding that “between 2.9% and 4.6% of women who take chemical abortion drugs end up in the emergency room, and (the physicians’) harms here are the furthest thing from speculative.”

A group of pharmaceutical companies, executives and investors submitted a “friend of the court” brief pointing up possible ramifications of the case. Avoiding the word “abortion,” the group said the 5th Circuit ruling would have consequences throughout the drug industry.

“Far from being limited to a single drug,” the pharmaceutical coalition wrote, “the logic of the decision below will create chaos for the drug development and approval processes. That decision casts a shadow of uncertainty over every FDA approval and invites spurious lawsuits challenging FDA’s safety and effectiveness determinations.”

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