Supreme Court weighs challenge to abortion pill’s availability

The Supreme Court on Tuesday tackles whether to maintain widely available access to the abortion pill mifepristone as it weighs a high-stakes challenge to the Food and Drug Administration’s drug approval process.

The court, which has a 6-3 conservative majority, hears oral arguments on the Biden administration’s appeal of lower court rulings that restricted access to the pill, including its availability by mail.

Mifepristone is used as part of a two-drug FDA-approved regimen for the majority of abortions nationwide.

The case is a major test for the conservative-majority court, which in 2022 overturned Roe v. Wade, the landmark ruling that established a woman’s constitutional right to end her pregnancy.

A group of anti-abortion doctors represented by Alliance Defending Freedom, a conservative Christian legal group, is leading the legal challenge, claiming that the FDA failed to adequately evaluate the drug’s safety risks.

The FDA has the backing of the pharmaceutical industry, which has warned that any second-guessing of the approval process by untrained federal judges could cause chaos and deter innovation.

Danco, which makes the brand version of the pill, Mifeprex, is arguing alongside the FDA in the oral argument.

The oral argument comes almost a year after Texas-based U.S. District Judge Matthew Kacsmaryk issued a sweeping ruling that completely invalidated the FDA’s approval of the pill, leading to panic among abortion rights activists that it would be banned altogether.

The Supreme Court last April put that ruling on hold, meaning the pill remains widely available for now.

The New Orleans-based 5th U.S. Circuit Court of Appeals in August then narrowed Kacsmaryk’s decision on appeal, but left in place his ruling finding that the FDA’s move to lift restrictions starting in 2016 was unlawful.

Both sides appealed to the Supreme Court. The court in December took up the Biden administration’s appeal in defense of the later FDA decisions, but it opted against hearing the challenge to the original approval of mifepristone in 2000. That issue is therefore not before the justices.

The court will instead focus on the later FDA action, including the initial 2021 decision that made it available by mail, which was finalized last year.

The court will also consider decisions in 2016 to extend the window in which mifepristone could be used to terminate pregnancies from seven weeks’ gestation to 10 weeks and reduce the number of in-person visits for patients from three to one. In another 2016 move, the FDA altered the dosing regimen, finding that a lower dose of mifepristone was sufficient.

One way the court could dispose of the case would be to conclude that the challengers do not have legal standing to bring their lawsuit, which would mean the justices would not wrestle with the question of FDA approval. If the court takes that route, it would leave the door open to a future case.

In court papers, the FDA has argued that the doctors and others who filed the lawsuit do not have legal standing because they cannot show any injury that can be traced to the drug approval process.

The doctors do not prescribe mifepristone, but they argue that they are injured because they could be required to treat patients who have taken the pill and have serious side effects. As they oppose abortion, any actions they are forced to take to help a woman complete the process would make them complicit, the plaintiffs argued in court papers.

The outcome of the case could have sweeping practical effects if access to the drug is restricted, with many states seeking to restrict abortion access in the wake of the Supreme Court’s decision to overturn Roe v. Wade.

There are 14 states where abortion is effectively banned altogether, according to the Guttmacher Institute, a research group that backs abortion rights.