The 67-page ruling by US District Judge Matthew Kacsmaryk in Amarillo, Texas, will not take effect for one week, in order to give the Biden administration a chance to file an emergency appeal.
A White House official said they are reviewing the abortion ruling.
Kacsmaryk’s ruling is a preliminary injunction that would essentially ban sales of mifepristone while the case before him continues. The judge, who was appointed to the bench by former Republican President Donald Trump, has not yet made a final ruling on the merits of the challenge.
However, in his ruling he found that the challenge is substantially likely to succeed. He said that the US Food and Drug Administration had ignored risks in approving the drug.
“The Court does not second-guess FDA’s decision-making lightly,” he wrote. “But here, FDA acquiesced on its legitimate safety concerns – in violation of its statutory duty – based on plainly unsound reasoning and studies that did not support its conclusions.”
Some abortion providers have said that if mifepristone is unavailable, they would switch to a regimen using only misoprostol for an abortion medication. However, the misoprostol-only regimen is not as effective, and it is not yet clear how widely available it would be.
Four anti-abortion groups headed by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the US Food and Drug Administration in November. They contend the agency used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug’s safety when used by girls under age 18 to terminate a pregnancy.
Mifepristone is part of the regimen for medication abortions, which account for more than half of all abortions in the country.
The Biden administration, responding to the lawsuit, has said the drug’s approval was well supported by science, and that the challenge comes much too late.
The judge’s ruling is likely to be appealed immediately to the New Orleans-based 5th US Circuit Court of Appeals, with the US Supreme Court as a next possible step after that.
During the hearing in the case, the judge raised questions about the regulatory process used by the FDA. Lawyers for the US Justice Department and an attorney for mifepristone’s manufacturer, Danco Laboratories, argued that the plaintiffs had no standing to bring the case and said mifepristone has an impressive safety and efficacy record.
The Justice Department also argued that a ruling in favor of the plaintiffs would undercut trust in the FDA, the agency that signs off on the safety of food products and drugs in the United States, and would increase the burden on surgical abortion clinics already overcrowded with women coming from states that now ban the procedure.
Since last year’s Supreme Court ruling, 12 of the 50 states now ban abortion outright while many others prohibit it after a certain length of pregnancy, according to the Guttmacher Institute, a research organization that supports abortion rights.
Mifepristone is available under the brand name Mifeprex and as a generic. Used in conjunction with misoprostol, it is approved to terminate a pregnancy within the first 10 weeks.
The FDA in January said that the government for the first time will allow mifepristone to be dispensed at retail pharmacies.
By choosing to sue in Amarillo, the plaintiffs ensured that the case would go before Kacsmaryk, a conservative former Christian activist. The Alliance for Hippocratic Medicine was incorporated in Amarillo just three months earlier.
The 5th Circuit has a conservative reputation, with more than two-thirds of its judges appointed by Republican presidents. The Supreme Court, which last year overturned the landmark 1973 Roe v. Wade ruling that had guaranteed the right to abortion nationwide, has a 6-3 conservative majority.
