Federal Judge Orders FDA to Freeze Approval of Abortion Pill Mifepristone

A woman looks at an abortion pill—RU-486, or mifepristone—displayed on a smartphone in Arlington, Va., on May 8, 2020. Olivier Douliery/AFP via Getty Images

A federal judge in Texas, in an unprecedented move, has ordered the U.S. Food and Drug Administration (FDA) to temporarily halt its approval of mifepristone, a drug used for abortion.

U.S. District Judge Matthew J. Kacsmaryk, a Trump appointee in Amarillo, Texas, signed an injunction directing the FDA to stay mifepristone’s approval, while the lawsuit that challenges the safety and approval of the drug continues.

Kacsmaryk said the FDA had ignored risks in approving the drug. “The Court does not second-guess FDA’s decision-making lightly,” reads the decision Friday (pdf). “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.

“There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion—which was the ’whole idea of mifepristone.'”

Kacsmaryk’s decision will not take effect for one week, allowing time for federal lawyers representing the Biden administration and FDA to file an emergency appeal.

The case may possibly eventually end up at the U.S. Supreme Court.

There is essentially no precedent for a lone judge overruling the decisions of the FDA.

The FDA said on Saturday that it appealed the decision and insisted that the abortion drug was “safe and effective.”

“FDA approved Mifeprex more than 20 years ago based on a comprehensive review of the scientific evidence available and determined that it was safe and effective,” the agency said in a statement. “FDA stands behind its determination.”

The immediate impact of the ruling was unclear.

Mifepristone, which has been widely used in the United States since 2000, is part of a chemical abortion process designed to kill an unborn child in pregnancies up to 10 weeks. It is also sometimes used for women who have miscarriages.

Chemical abortion, also referred to by other terms such as “abortion by medication,” is the most popular method of abortion in the United States, comprising more than half of total U.S. abortions.

It involves a two-drug regimen. Specifically, mifepristone blocks progesterone, thereby depriving the unborn child of nutrients needed to stay alive, and stops the pregnancy from progressing. A second drug, misoprostol, induces labor to expel the unborn child.

Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a chemical abortion, are seen at the Women's Reproductive Clinic in Santa Teresa, N.M., on June 17, 2022. Robyn Beck/AFP/Getty Images

Mifepristone is for now available as a generic drug, and also available under the brand name Mifeprex. In January, the FDA said the Biden administration is allowing mifepristone to be dispensed at retail pharmacies. The move faced criticisms from attorney generals from 22 U.S. states, who called it illegal and dangerous.

Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.

Kacsmaryk’s ruling comes in a lawsuit filed in November 2022 by the Alliance Defending Freedom. The group alleged the FDA’s initial approval of mifepristone in 2000 was flawed because it did not adequately review its safety risks when used by girls under age 18 to terminate a pregnancy.

The Biden administration, in response to the lawsuit, said the FDA’s approval was supported by science, and that the legal challenge comes too late.

Alliance Defending Freedom Senior Counsel Erik Baptist called the decision Friday “a significant victory” for the health and safety of women and girls.

“By illegally approving dangerous chemical abortion drugs, the FDA put women and girls in harm’s way, and it’s high time the agency is held accountable for its reckless actions,” he said in a statement.

“Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they can pose serious and life-threatening complications to the mother, in addition to ending a baby’s life. The FDA never had the authority to approve these hazardous drugs and remove important safeguards.”

The case is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.

Currently, 16 U.S. states have laws targeting chemical abortion.

With limited exceptions, abortions are illegal or are unavailable in 14 U.S. states: Alabama, Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, West Virginia, and Wisconsin.

The Associated Press contributed to this report.