Judge reverses FDA approval of abortion drug after 23 years

Judge reverses FDA approval of abortion drug after 23 years

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.

Used boxes of Mifepristone pills, the first drug used in a medical abortion, fill a trash at Alamo Women’s Clinic in Albuquerque, N.M., Jan. 11, 2023.

Evelyn Hockstein/Reuters, FILE

Meanwhile, a Washington state judge issued a dueling injunction on Friday in a separate case regarding the status of the FDA’s approval of mifepristone. In his ruling, Judge Thomas Rice of Washington’s Eastern Federal District Court granted the preliminary injunction requested by the plaintiffs, made up of Democratic attorneys general, and prevents the FDA from “altering the status quo and rights as it relates to the availability of 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 Texas lawsuit, said after the March 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.

PHOTO: In this Jan. 13, 2023, file photo, a patient prepares to take mifepristone, the first pill given in a medical abortion, at a reproductive clinic in New Mexico.

In this Jan. 13, 2023, file photo, a patient prepares to take mifepristone, the first pill given in a medical abortion, at a reproductive clinic in New Mexico.

Evelyn Hockstein/Reuters, FILE

“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.

ABC News has asked the FDA and DOJ for comment.

An appeal is likely in the Texas case. If the conservative 5th Circuit Court of Appeals upholds the Texas ruling — and the two federal orders remain in conflict — the issue is likely to be expedited to go before the Supreme Court.

Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America, said in a statement to ABC News that the judge’s decision in Texas “could threaten the FDA’s role in this country’s public health system, and — if allowed to stand — will have broad and unprecedented consequences that reach far beyond abortion.”

The decision “is an outrage and exposes the weaponization of our judicial system to further restrict abortion nationwide. However, I want to be clear that access to mifepristone remains safe for now,” the statement said. “But we should all be enraged that one judge can unilaterally reject medical evidence and overrule the FDA’s approval of a medication that has been safely and effectively used for more than two decades.”

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

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