WASHINGTON — The U.S. Supreme Court blocked a Texas judge’s restrictions on a widely used abortion pill from taking effect, keeping the drug fully available while a legal fight goes forward.
The highest court, without explanation and over two dissents, granted requests from the Biden administration and Danco Laboratories LLC, which makes the drug. The government said the restrictions, which were set to take effect at the end of Friday, would have created regulatory chaos and made it impossible to legally sell mifepristone across state lines in the near term.
The order applies while the government and Danco make their case before a federal appeals court and, if necessary, seek a full Supreme Court review.
The case was the Supreme Court’s first abortion test since it overturned the landmark Roe v. Wade ruling in June and let states enforce bans for the first time in a half century. Buoyed by that ruling, opponents of the procedure are seeking to go further, targeting a drug now used in more than half the nation’s abortions.
The focus of the fight now shifts to the New Orleans-based 5th U.S. Circuit Court of Appeals, which on May 17 will hear appeals by the Food and Drug Administration and Danco of U.S. District Judge Matthew Kacsmaryk’s order.
President Joe Biden welcomed the decision. “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.
Justices Clarence Thomas and Samuel Alito dissented, saying they would have let the restrictions take effect. Alito said the curbs wouldn’t have removed the drug from the market and simply would have reinstated the rules that applied until 2016.
Alito said the administration and company “have not shown that they are likely to suffer irreparable harm in the interim.”
The Christian legal advocacy group behind the suit, Alliance Defending Freedom, cast the decision as a procedural one.
“As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge to the FDA’s illegal approval of chemical abortion drugs and its removal of critical safeguards for those drugs moves forward,” Erik Baptist, a lawyer with the group, said in an emailed statement.
Jessica Ellsworth, an attorney representing Danco Laboratories, said in an emailed statement that the order “preserves crucial access to a drug relied on by millions of patients.”
Abortion-rights advocates said they weren’t declaring victory even as they breathed a sigh of relief.
“Make no mistake, we aren’t out of the woods by any means,” Jennifer Dalven, director of the American Civil Liberties Union’s Reproductive Freedom Project, said in an emailed statement. “This case, which should have been laughed out of court from the very start, will continue on.”
Kacsmaryk, a Donald Trump appointee who has written critically about Roe v. Wade, invalidated the FDA’s 2000 approval of mifepristone, saying the agency had given short shrift to safety issues. The 5th U.S. Circuit Court of Appeals then partially stayed that ruling, leaving mifepristone’s approval in force while blocking steps the FDA took to loosen restrictions starting in 2016.
Had they taken effect, the restrictions would have barred mifepristone from being prescribed after the seventh week of pregnancy, cutting its availability by three weeks. The lower court orders also would have required patients to make three visits to a clinic, eliminated delivery by mail and barred non-physicians from dispensing or prescribing the drug.
The orders also would have stripped the generic version of mifepristone of its federal approval. The generic version’s maker, GenBioPro Inc., told the court it supplies two-thirds of the mifepristone used in the U.S. GenBioPro filed its own lawsuit Wednesday, seeking to preserve its right to sell the drug.
Evan Masingill, the chief executive officer of GenBioPro, said Supreme Court’s order keeps mifepristone lawful and available. “The Texas order has no basis in law or fact,” Masingill said. “We urge the Fifth Circuit to overturn the order as this case goes to an appeal.”
How much further the restrictions would have gone was a matter of some dispute. The Biden administration and Danco said the orders would have immediately rendered existing doses of mifepristone mislabeled, forcing the company to go through a months-long process to bring the drug into compliance. Abortion opponents called that time estimate an overstatement.
In his dissent, Alito questioned the contention that Danco would be unable to sell the drug. That wouldn’t happen “unless the FDA elected to use its enforcement discretion to stop Danco, and the applicants’ papers do not provide any reason to believe the FDA would make that choice,” he wrote.
Thomas didn’t provide any explanation for his vote, saying only that he would have rejected the requests.
The Supreme Court order supersedes a temporary hold Alito had placed on Kacsmaryk’s decision to give the justices more time to decide what to do. Alito’s hold had been set to expire on Wednesday before he added a two-day extension.
Abortion opponents were able to hand-pick Kacsmaryk for their case by filing in the federal court in Amarillo, Texas, where he is the only judge.
The cases are Danco Laboratories v. Alliance for Hippocratic Medicine, 22A901, and U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, 22A902.
(Fiona Rutherford, Madlin Mekelburg, Justin Sink and Courtney Rozen contributed to this report.)
