Read the transcript of the Texas court hearing on the fate of mifepristone

A Texas federal judge 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 on Wednesday was open to the public but it was not broadcast live.

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

The Alliance Defending Freedom has argued that mifepristone is unsafe and that the FDA did not properly follow its approval process when it authorized the use of mifepristone in 2000. The Department of Justice strongly disputed these allegations, arguing that the FDA used its powers authorized by Congress to approve a drug it determined. is safe and effective.

“This Court will render an order and an opinion as soon as possible,” Kacsmaryk said at the end of the hearing.

Erik Baptist, the lead attorney for Alliance Defending Freedom, told the judge he had the authority to order the FDA to initiate its internal process to remove a drug from the market, but argued that a such action would be inappropriate in this case as it could take “many years”.

Instead, Baptist argued that the court can “on its own initiative” order the FDA to remove the drug from the market rather than relying on the agency to initiate its internal procedures to do so.

“Any relief you award, Your Honor, must be comprehensive. The scope of plaintiffs – of that relief must be universal and national,” Baptist told the judge.

Kacsmaryk asked Baptist to explain why the court had such “absolute authority.” Baptist said the court had the power to “take any action to prevent damage.” The judge also asked Baptist if he could cite another case where a court took down a drug that had been on the market for more than 20 years.

“My answer to your question is no, I can’t,” Baptist said, though he argued that was because the FDA had blocked previous petitions to remove mifepristone and impose tighter restrictions.

Julie Straus Harris, a Justice Department attorney, said the statute of limitations bars plaintiffs from challenging the FDA’s 2000 approval of mifepristone. Harris argued the public interest would be “irreparably harmed” by an order removing mifepristone from the market.

“An injunction would cause 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 upset the status quo and hurt patients, doctors and the pharmaceutical industry’s reliance on FDA drug approvals.

Kacsmaryk sparked controversy ahead of closing arguments after the Washington Post reported he was seeking to keep news of the hearing date secret. Citing death threats and harassment, Kacsmaryk told attorneys involved in the case that “less publicity is better” during a conference call last week, according to a court transcript.

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

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