Supreme Court preserves access to key abortion drug as appeal proceeds

As is typical in emergency actions, the majority did not explain its reasoning for putting the lower court decision on hold. In the only noted dissents, Justices Clarence Thomas and Samuel A. Alito Jr. said they would not have granted the Biden administration’s request for a stay of the decision by a panel of the U.S. Court of Appeals for the 5th Circuit.

Thomas did not explain his reasoning. Alito said the administration and the public would not have been harmed by agreeing with the lower court, which wanted to reimpose restrictions loosened by the FDA in recent years.

“It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations,” Alito wrote. He disputed that the court’s intervention at this time would have sent a signal: “Contrary to the impression that may be held by many, that disposition would not express any view on the merits of the question whether the FDA acted lawfully in any of its actions regarding mifepristone.”

The 5th Circuit next month will review the merits of the case brought by antiabortion groups against the FDA’s regulation of mifepristone — a review that will be conducted by a separate, and likely different, three-judge panel than the one that made the initial ruling. That merits decision will almost surely be appealed to the Supreme Court no matter the outcome. But until then, the justices’ Friday order says the status quo will remain in place: Mifepristone will be available under existing FDA regulations nationwide.

President Biden quickly praised the court’s action. “I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.” he said in a statement. “The stakes could not be higher for women across America. I will continue to fight politically-driven attacks on women’s health. But let’s be clear — the American people must continue to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v. Wade.”

The court’s order Friday was the latest development in what has been a rapid and at times confusing legal battle over mifepristone, which is used as part of a two-drug regimen in more than half of the nation’s abortion procedures. The second drug, misoprostol, can also be used on its own to terminate early pregnancies, but the two drugs in tandem reduce cramping and bleeding.

Medications to terminate pregnancy have increased in importance as states limit or ban abortions after the Supreme Court’s ruling last June in Dobbs v. Jackson Women’s Health Organization, in part because the drugs can be sent by mail and taken at home.

Drugmakers, the Biden administration and abortion providers say all the agency’s decisions are science-based and proper, based on two decades of accumulated clinical studies of the drug’s use. Antiabortion groups have attacked the FDA’s approval of mifepristone, as well as more-recent changes making the drug more accessible.

Both sides vowed to fight on after Friday’s order.

“The FDA must answer for the damage it has caused to the health of countless women and girls and the rule of law by failing to study how dangerous the chemical abortion drug regimen is and unlawfully removing every meaningful safeguard,” Erik Baptist, senior counsel for the Alliance Defending Freedom, which represents the antiabortion groups, said in a statement. “We look forward to a final outcome in this case that will hold the FDA accountable.”

The justices were considering a temporary but broad 5th Circuit order reversing several FDA actions since 2016 that increase access to mifepristone. The agency had approved the drug’s use through 10 weeks of pregnancy instead of seven, allowed patients to get mifepristone through the mail and authorized prescriptions by medical professionals other than doctors.

The appeals court action followed U.S. District Judge Matthew Kacsmaryk’s recent ruling in Texas to suspend the FDA’s approval of mifepristone altogether. More than 5 million women have used mifepristone to end their pregnancies since it was first cleared for use in the United States in 2000.

The Biden administration and drugmakers called Kacsmaryk’s decision an unprecedented attack on the expertise of the FDA, which relied on data from dozens of clinical trials when it approved the drug. They told the Supreme Court that the lower court rulings would create chaos for abortion providers and upend the FDA’s regulatory authority, with far-reaching repercussions for other, non-abortion-related drugs.

Shortly after the ruling, several abortion providers emphasized that access to mifepristone will remain the same, and said there will be no changes in their protocols as the case winds its way through the courts. For days, providers had been bracing for the possibility that the process for medication abortions could be upended.

“The greatest feeling right now is relief,” said Melissa Grant, the chief operations officer of Carafem, a group of abortion clinics and telehealth services. “We were poised and ready to potentially react to one of many possible outcomes, all of which potentially decreased access to what amounts to life-changing medication for women across our country.”

But, she added, “we are aware this is not the end, and that there’s still a great deal of concern about the future of abortion care in our country.”

The Alliance for Hippocratic Medicine, an association of antiabortion doctors and others, filed its lawsuit in Amarillo, where Kacsmaryk — a nominee of President Donald Trump with long-held antiabortion views — is the sole sitting judge. The group has a mailing address in Tennessee, records show, and incorporated in Texas several months before submitting its legal challenge. The group says the FDA succumbed to political pressure in approving mifepristone and then lifting restrictions over its use.

Kacsmaryk agreed with the alliance’s claim that the FDA did not follow proper procedure or sufficiently consider safety concerns. The judge’s April 7 ruling was the first time a court issued an order to suspend a long-approved medication. His language echoed terminology used by antiabortion activists, referring to abortion providers as “abortionists” and to fetuses and embryos as “unborn humans.”

The Justice Department and Danco Laboratories, the pharmaceutical company that makes mifepristone, appealed the ruling to the 5th Circuit.

The appeals court panel, which was charged with considering the government’s request for a stay, agreed 2-1 with Kacsmaryk that the FDA failed to examine relevant data when it eliminated certain safeguards in 2016. The panel also said the individual doctors and antiabortion associations probably have sufficient legal grounds to proceed with their challenge because there are instances when a medication abortion is unsuccessful and requires additional treatment.

A different panel of judges is expected to hold oral arguments on Kacsmaryk’s decision on May 17.

In the government’s request for a stay of the 5th Circuit decision, Solicitor General Elizabeth B. Prelogar told the Supreme Court that challengers should not be granted legal standing because they do not take or prescribe mifepristone. The challengers, she wrote, were ignoring the significant chaos a ruling in their favor would cause for patients, prescribers and the health-care system.

“Nor do they justify the harm of denying women lawful access to a drug under conditions FDA determined are safe and effective and instead requiring them to undergo invasive surgical procedures,” Prelogar wrote.

Adding to the complex legal situation, on the same day that Kacsmaryk ruled, a federal judge in Washington state issued a contradictory decision in a separate mifepristone-related lawsuit filed by Democratic attorneys general. The judge ordered the FDA not to make any changes to the availability of the drug in 17 states and the District of Columbia, all of which are part of the litigation.

In his four-page dissent, Alito criticized some of his colleagues for agreeing to put the lower court decisions on hold without more consideration, singling out past opinions on that issue from Justices Sonia Sotomayor, Elena Kagan and Amy Coney Barrett.

He discounted the FDA’s argument that the rulings from Texas and Washington would have created “chaos,” and expressed skepticism that the regulatory agency would not have found a way to keep mifepristone on the market.

“The FDA has previously invoked enforcement discretion to permit the distribution of mifepristone in a way that the regulations then in effect prohibited, and here, the Government has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases, much less that it would choose to take enforcement actions to which it has strong objections,” Alito wrote.

The cases are FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.

David Ovalle, Rachel Roubein and Caroline Kitchener contributed to this report.