US Judge Hands Anti-abortion Groups Partial Win Over Mifepristone Pill

A federal judge on Friday halted federal regulators’ approval of the abortion pill mifepristone while a legal challenge proceeds, partially granting a request by anti-abortion groups and dealing another setback to abortion rights in the United States.

The 67-page ruling by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, allows the Biden administration one week to appeal the decision, according to court documents.

Representatives for White House could not be immediately reached for comment.

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 President Donald Trump, did not rule on the merits of the challenge. The injunction will remain in place until the judge makes a final judgment or it is reversed on appeal.

Some abortion providers have said that if mifepristone is unavailable, they would switch to a regimen using only misoprostol for a medication abortion. 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 U.S. Food and Drug Administration in November. They contended 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 in the United States for medication abortions, which account for more than half of all abortions in the country.

President Joe Biden’s 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 U.S. Circuit Court of Appeals, with the U.S. 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 U.S. 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 abortion.

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 another drug called misoprostol, it is approved to terminate a pregnancy within the first 10 weeks of a pregnancy.

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 has a 6-3 conservative majority.

Mifepristone is also the subject of lawsuits in West Virginia and North Carolina seeking to expand access to the drug by arguing that state restrictions conflict with federal law, and a lawsuit by Democratic state attorneys general seeking to remove federal restrictions on how it can be distributed.