Judge reverses FDA approval of abortion drug after 23 years

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

US District Judge Matthew Kacsmaryk has decided to suspend the FDA's approval of mifepristone. The ruling was suspended for seven days so the federal government could appeal.

Kacsmaryk, Trump's nominee, held a hearing on the matter March 15 in Amarillo, Texas, where the conservative plaintiffs in the case argued that the Food and Drug Administration wrongly approved mifepristone.

Meanwhile, a Washington state judge issued a dueling order Friday in a separate case regarding the FDA's approval status of mifepristone.

In his ruling, Judge Thomas Rice of Washington's Eastern Federal District Court granted the initial order requested by the plaintiffs, who are made up of Democratic attorneys general, and prevented the FDA from “changing the status quo and rights relating to the availability of mifepristone.”

About half of all abortions in the US were drug abortions in 2020, according to data compiled 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 at Alliance Defending Freedom, the group that filed the Texas lawsuit, said after a March hearing that the judge needed to present a check on the FDA, which he said overlooked safety concerns with mifepristone – an accusation the government denies.

“The FDA has never had the authority to approve these drugs and it takes away important protections,” Baptist said.

Government lawyers defending the FDA told the hearing that the government had reviewed the data extensively and found no such safety concerns.

“The public interest will suffer dramatically” by siding with plaintiffs, said Julie Straus Harris, a Justice Department attorney, while Baptist urged judges: “Relief must be comprehensive and national.”

On the outside, pro-abortion access advocates are forthright. “There are a lot of reasons why this court should just drop (the lawsuit),” said Carrie Flaxman, senior director of litigation and public policy law at the Planned Parenthood Federation of America.

Appeal possible.