Judge reverses FDA approval of abortion drug after 23 years


(AMARILLO, Texas) — A federal judge in Texas on Friday ruled to suspend the abortion drug mifepristone, which was approved by regulators 23 years ago and has now become one of the most common methods of abortion in the country.

U.S. District Judge Matthew Kacsmaryk ruled to suspend the FDA’s approval of mifepristone. The ruling is paused for seven days so the federal government may appeal.

Kacsmaryk, a Trump appointee, held a hearing on the issue on March 15 in Amarillo, Texas, where the conservative plaintiffs in the case argued the Food and Drug Administration was wrong to approve mifepristone.

About half of all abortions in the U.S. were medication abortions as of 2020, according to data collected by the Centers for Disease Control and Prevention. Such methods usually rely on mifepristone in a two-drug regimen along with misoprostol.

Erik Baptist, senior counsel with Alliance Defending Freedom, the group that filed the lawsuit, said after the hearing that the judge needed to provide a check on the FDA, which he said ignored safety concerns with mifepristone — an allegation the government and most medical doctors refute.

“The FDA never had the authority to approve these drugs and remove important safeguards,” Baptist said.

Government lawyers defending the FDA said at the hearing that the government has reviewed extensive data and found no such safety concerns.

“The public interest would be dramatically harmed” by siding with the plaintiffs, said Julie Straus Harris, an attorney for the Justice Department, while Baptist urged the judge: “Relief must be complete and nationwide.”

Outside, pro-abortion access advocates were blunt. “There are a whole host of reasons why this court should just dismiss [the lawsuit] out of hand,” said Carrie Flaxman, senior director for public policy litigation and law with Planned Parenthood Federation of America.

An appeal is likely.

This is a developing story. Please check back for updates.

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