The delay could indicate the court is not unanimous in how to handle its first major abortion-related controversy since overturning Roe v. Wade’s constitutional guarantee of abortion rights last year. Behind-the-scenes negotiations may be continuing, or a majority of the court may have reached a decision, while one or more justices have decided to write dissents and want more time.
The Biden administration, abortion providers and antiabortion activists, drugmakers and the Food and Drug Administration have engaged in a rapid and at times confusing legal battle over mifepristone, which is used in more than half of the nation’s abortion procedures. The drug, which currently can be obtained by mail and administered at home, has become even more important as states limit or ban elective abortions following the Supreme Court’s ruling last June in Dobbs v. Jackson Women’s Health Organization.
The justices are now considering a decision of the U.S. Court of Appeals for the 5th Circuit that rolled back the FDA’s actions since 2016 liberalizing access to mifepristone — allowing patients to get the drug through the mail, authorizing prescriptions by medical professionals other than doctors and approving the drug’s use up to 10 weeks into a pregnancy, instead of seven.
The appeals court action followed U.S. District Judge Matthew Kacsmaryk’s recent ruling in Texas to undo altogether the FDA’s approval of mifepristone more than two decades ago. More than 5 million women have since used the drug — in combination with a second pill, misoprostol — to end their pregnancies.
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 confusion and uncertainty for abortion providers and have devastating consequences for the pharmaceutical industry’s ability to bring new drugs to market.
The challengers, an association of antiabortion doctors and others, said the FDA had succumbed to political pressure in approving the drug and then lifting restrictions over its use.
Patients can terminate pregnancies using misoprostol alone, although that process can involve more cramping and bleeding. Abortion providers have said they will continue offering medication abortions regardless of what happens with mifepristone.
The group behind the Texas challenge, the Alliance for Hippocratic Medicine, filed the lawsuit in Amarillo, where Kacsmaryk, a nominee of President Donald Trump with long-held antiabortion views, is the sole sitting judge.
Kacsmaryk agreed with the alliance’s claim that the FDA did not follow proper procedure or sufficiently consider safety concerns when it cleared mifepristone for use in the United States in 2000. The judge’s April 7 ruling was the first time a court had ordered the suspension of a long-approved medication, and medical experts said the decision ignored hundreds of scientific studies attesting to the drug’s safety.
The appeals court, which has scheduled oral arguments in the case on May 17, declined to undo FDA approval of mifepristone for now. But it agreed with Kacsmaryk that the FDA failed to examine relevant data when it loosened regulations and eliminated certain safeguards in 2016. The FDA “relied on zero studies that evaluated the safety-and-effectiveness consequences” of the overall changes, according to the opinion by Judges Andrew Oldham and Kurt D. Engelhardt, both Trump nominees.
In response, Solicitor General Elizabeth B. Prelogar told the Supreme Court that the challengers were disregarding the “mountain of evidence and experience validating the judgment of FDA and other regulators around the world,” and ignoring the significant chaos a ruling in their favor would cause for patients, prescribers and the health-care system.
Further complicating the 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 directed the FDA not to make any changes to the availability of the drug in 17 states and D.C., all of which joined the litigation.
The cases before the Supreme Court are FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.
