Read the Texas Court Transcript on the Fate of Mifepristone

Abortion rights advocates gather in front of the Federal Building and the J. Marvin Jones Courthouse in Amarillo, Texas, on March 15, 2023.

Moises Avila AFP | Getty Images

A federal judge in Texas heard arguments for the first time this week in a closely watched case challenging the Food and Drug Administration’s approval of mifepristone.

Wednesday’s Amarillo hearing was open to the public but was not broadcast live.

Judge Matthew Kachsmary of the Northern District of Texas in Amarillo heard arguments for four hours. The anti-abortion group that filed the lawsuit, the Alliance Defending Freedom, was the first to present its case against the FDA. They were followed by Justice Department lawyers defending the FDA and then the abortion pill maker Danco Laboratories.

The Freedom Alliance argued that mifepristone was not safe and that the FDA did not properly follow its approval process when it approved mifepristone for use in 2000. The Justice Department strongly disputed these claims, arguing that the FDA used its powers granted by Congress to approve the drug it had identified. is safe and effective.

Download the full transcript of the hearing here.

“This court will issue a ruling and an opinion as soon as possible,” Kachmari said at the conclusion of the hearing.

Eric Baptiste, chief legal officer for Alliance Defending Freedom, told the judge he had the right to order the FDA to initiate an internal withdrawal process, but said such action would be inappropriate in this case because it could take “many years.”

Instead, Baptist argued that the court could “at its own discretion” order the FDA to withdraw a drug from the market, rather than relying on the agency to initiate its own internal procedures to do so.

“Any assistance you provide, Your Honor, must be complete. The scope of this assistance to plaintiffs should be universal and nationwide,” Baptist told the judge.

Kachmari asked Baptist to explain why the court has such “broad powers”. Baptist said the court has the power to “take any action to prevent harm.” The judge also asked Baptiste if he could point to any other court recall of a drug that has been on the market for over 20 years.

“My answer to your question is: no, I can’t,” Baptiste said, though he claimed it was because the FDA had blocked previous petitions to end mifepristone and impose tighter restrictions.

Julie Strauss Harris, a Justice Department attorney, said the statute of limitations barred plaintiffs from challenging the 2000 FDA approval of mifepristone. Harris argued that the public interest would be “irreparably damaged” by an order to withdraw mifepristone from the market.

“An injunction would cause significant public harm by depriving patients and doctors of a safe and effective drug that has been on the market for more than two decades,” Harris said. She argued that such an order would change the status quo and hurt patients, doctors, and the pharmaceutical industry’s reliance on FDA drug approval.

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Kachmari caused controversy ahead of the oral argument after The Washington Post reported that he sought to cover up news of the hearing date. Citing death threats and harassmentAccording to court transcripts, Kachmari told lawyers involved in the case that “the less publicity, the better” during a conference call last week.

The court eventually relented and set the date Monday after media outlets, including the NBCUniversal News group of which CNBC is a part, filed a letter criticizing the move as “unconstitutional.”

“The Court’s attempt to delay notice and therefore limit the ability of members of the public, including members of the press, to attend Wednesday’s hearings is unconstitutional and undermines the important values ​​of public access to court proceedings and court records,” wrote Peter Steffensen of the Legal Southern Methodist University’s Dedman School on behalf of the media.