The Supreme Court Preserves Abortion Pill Access—Temporarily

The US Supreme Court on Friday temporarily blocked a lower court’s order that would have banned the abortion pill mifepristone. The action means that the drug will remain available and legal under status quo regulations until the case works its way through the appeals process, which could take months.

The court’s ultimate ruling could be the most consequential decision on reproductive rights since its overturning of Roe v. Wade in June 2022.

Mifepristone has been available in the United States since 2000, when the US Food and Drug Administration approved its use. It’s the first dose of a two-drug series used in a medication abortion, which now accounts for over half of all abortions across the country. Access to medication abortion is already limited in 15 states.

But on April 7, Judge Matthew Kacsmaryk of the Northern District of Texas ruled to rescind the approval of the pill nationwide. The plaintiffs in the case, antiabortion doctors, argued that the drug is unsafe and the FDA’s authorization was improper because pregnancy is not an illness. However, the drug has a decades-long track record of safety, and a comprehensive review conducted by the National Academies of Sciences confirmed that it has a very low rate of serious complications.

The following week, the Fifth Circuit Court of Appeals partially blocked Kacsmaryk’s decision, allowing the pill to retain its FDA approval but rolling back several changes the agency has made in recent years to expand access to it. Among them: pandemic-era provisions that made mifepristone easier to prescribe online and distribute by mail and a 2016 change that allowed the pill to be taken up to the 10th week of pregnancy. 

The US Department of Justice, acting on behalf of the FDA, and New York-based Danco Laboratories, which makes mifepristone, asked the justices to intervene. Over the past week, the Supreme Court issued two separate short-term holds as it considered the matter. The court had given itself a deadline of Wednesday by midnight to decide whether the pill would face tighter rules while an appeal moves forward, but it extended that deadline to today. 

GenBioPro, the manufacturer of a generic form of mifepristone, entered the fray this week with a lawsuit against the FDA. If mifepristone’s approval is revoked, GenBioPro’s generic version would also be suspended. The company alleges that if the FDA complies with Kacsmaryk’s ruling, it would violate the established legal process for withdrawing a previously approved drug from use.

“There is a very detailed procedure of removing drugs from the market,” says Ameet Sarpatwari, a lawyer and assistant professor of medicine at Harvard Medical School. Kacsmaryk’s ruling circumvents that established process, Sarpatwari says. Manufacturers and the FDA have removed drugs from the market before, either because of low demand or dangers to patients, but a court has never stepped in to pull a long-approved drug from use.

Pharmaceutical companies and drug manufacturers say the lower courts’ rulings represent an unprecedented intrusion into the authority of the FDA. The agency is tasked with reviewing, approving, and regulating drugs for their safety and efficacy. They say if mifepristone is banned or restricted, it puts other drugs in danger, particularly ones vulnerable to political pushback, such as hormonal birth control, preventive HIV drugs, and vaccines.

More than 600 executives from biotech and pharmaceutical companies have signed a letter warning that pulling mifepristone off the market would have a chilling effect on innovation. Companies often spend billions of dollars to get a drug through the development pipeline, and they would hate to have their investment quashed by the courts. “You could see decreased investment because of uncertainty as to whether or not courts are going to take action on decades-old drugs,” Sarpatwari says.

There are a few scenarios in which mifepristone could remain available—or come back onto the market—even if the Supreme Court affirms Kacsmaryk’s ruling to pull its approval, Sarpatwari says. The FDA could exercise its “enforcement discretion,” meaning the agency wouldn’t prosecute manufacturers, distributors, or providers making the drug available. Another option is that the FDA could rapidly reapprove mifepristone based on decades of scientific studies that back up its safety and efficacy. 

Medication abortion is still possible even without mifepristone. It can be carried out with just misoprostol, the second drug taken in the two-step regimen. But misoprostol is less effective on its own. 

Alicia Hughes, visiting assistant professor and interim director of the Center for Civil Rights and Social Justice at Emory School of Law, said she had not expected the Supreme Court to uphold Kacsmaryk’s ruling. “That would be stunning,” she says. “That would mean judges would be in a position to essentially take on executive function through a court ruling.” 

But we could be waiting until next year for the final word from the Supreme Court, says Allison Whelan, assistant professor of law at Georgia State University. “While I could not be sure, I did think it was likely for the court to grant the stay and maintain the status quo while the case proceeds on the merits,” she says. “That said, I expect that the Supreme Court will have to address this issue once again on the merits once the case plays out in the lower courts.”

And in a statement to WIRED, Hughes points out that this legal battle could be only the first of many challenges to FDA drug approvals. “Today, it's an abortion pill we're challenging the FDA's authority to regulate. Depending on final outcomes at the High Court in this case, we may be facing challenges to invalidate medications approved by the FDA to treat, for example, cancer, another disease, or a vaccine tomorrow, simply because a group may not like what the drug does, or the impact it has on some other political issue to which they may be opposed," she writes. "Nothing would be off the table, and this is a dangerous precedent.”