Abortion pill battle: 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.

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

U.S. Northern District of Texas Judge Matthew Koksmark heard arguments for four hours in Amarillo. The anti-abortion group that filed the lawsuit, the Alliance Defending Freedom, first presented its case against the FDA. After that, Justice Department lawyers defended the FDA and then the abortion pill maker Danco Laboratories.

Alliance Defending Freedom argued that mifepristone is unsafe and that the FDA did not properly follow the approval process when it cleared mifepristone for use in 2000. The Justice Department strongly disputed these claims, arguing that the FDA exercised powers granted by Congress to approve the drug it recommended. is safe and effective.

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

Eric Baptiste, a senior attorney with the Alliance Defending Freedom, told the judge that he had the authority to order the FDA to begin its own internal process to remove the drug from the market, but argued that in this case it could not. Such action would be inappropriate because it could take “several years”.

Instead, Baptiste argued, the court could “arbitrarily” 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. Do it.

“Any relief you grant, Your Honor, must be complete,” Baptiste told the judge.

Coxmark asked Baptiste to explain why the court had such “sweeping authority.” Baptist said the court has the power to “take whatever steps are necessary to prevent harm”. The judge also asked Baptist if he could point to any other court cases to withdraw the drug, which has been on the market for more than 20 years.

“My answer to your question is, no, I can’t,” Baptiste said, though he argued that’s because the FDA blocked previous requests to pull mifepristone and impose stricter restrictions. .

Julie Strauss-Harris, a lawyer for the Justice Department, said the statute of limitations prevents plaintiffs from challenging the FDA’s approval of mifepristone in 2000. Harris argued that ordering mifepristone off the market would cause “irreparable harm” to the public interest.

“An injunction would cause 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. He argued that such an order would perpetuate the status quo and undermine the reliance of patients, doctors and the pharmaceutical industry on FDA drug approvals.

Coxmark sparked controversy ahead of oral arguments when The Washington Post reported that he tried to keep news of the hearing date quiet. Citing death threats and harassment.Kacsmaryk told lawyers involved in the case that “less publicity is better” during a telephone conference call last week, according to court transcripts.

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

“The court’s attempt to delay notice and, therefore, limit the ability of members of the public, including the press, to attend Wednesday’s hearing is unconstitutional, and presented through public access to court proceedings and court records.” It undermines important values,” it wrote. Peter Stephenson of Southern Methodist University’s Dedman School of Law on behalf of media outlets.