Abortion pill fight: Read transcript of Texas court hearing on mifepristone’s fate

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.

The hearing in Amarillo was open to the public on Wednesday, but was not livestreamed.

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

The Alliance Defending Freedom argued that mifepristone is unsafe and that the FDA did not properly follow its approval process when it approved mifepristone for use in 2000. The Justice Department strongly disputes those claims, arguing that the FDA used its congressionally authorized powers to approve the prescribed drug. Safe and effective.

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

Eric Baptiste, top attorney for the Alliance Defending Freedom, told the judge that he has authority to order the FDA to begin an internal process to withdraw the drug from the market, but argued that such action would be inappropriate in this case because it ” may take several years”.

Instead, Baptiste argued, the court could “of its own accord” order the FDA to withdraw the drug from the market rather than relying on the agency to initiate its own internal procedures to do so.

Baptiste told the judge, “Whatever relief you grant, Your Honor, it must be complete. The scope of the plaintiff—the scope of this relief must be universal and nationwide.”

Kacsmaryk asked Baptiste to explain why the court had such “broad authority”. Baptiste 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 cases of drug withdrawals that have been on the market for more than 20 years.

“My answer to your question is, no, I can’t,” Baptiste said, although he argued that this is because the FDA rejected previous petitions to remove mifepristone and impose stricter restrictions.

Julie Strauss Harris, a Justice Department attorney, said the statute of limitations bars the plaintiffs from challenging the FDA’s approval of mifepristone in 2000. Harris argued that the public interest would be “irreparably injured” by an order to remove mifepristone from the market.

“An injunction would result in significant public harm, 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 perpetuate the status quo and harm patients, doctors and the pharmaceutical industry’s reliance on FDA drug approval.

Kacsmaryk courted controversy prior to oral arguments after The Washington Post reported that he sought to keep the hearing date quiet. Cited death threats and harassmentKaczmarić told lawyers involved in the case during a telephone conference call last week that “the less advertising the better,” according to a court transcript.

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

“The attempt to delay notice of the court, and therefore, limit the ability of members of the public, including the press, to attend Wednesday’s hearing is unconstitutional, and undermines the important values ​​provided by public access to judicial proceedings and court records.” does less,” wrote Peter Stephenson of Southern Methodist University’s Deadman School of Law on behalf of media outlets.