Abortion rights supporters gather outside the Federal Constructing and the J Marvin Jones Courthouse in Amarillo, Texas, March 15, 2023.
Moises Avila | AFP | Getty’s paintings
A Texas federal judge first heard the case this week in a closely watched case difficult the Food and Drug Administration’s approval of Mifepristone.
The Amarillo trial on Wednesday was open to the public but was not broadcast live.
Judge Matthew Kacsmaryk of the Northern District of Texas in Amarillo heard 4 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 lawyers defending the FDA, after which abortion pill maker Danco Laboratories.
The Alliance Defending Freedom argued that mifepristone was dangerous, and the FDA didn’t properly follow the approval process when it approved mifepristone to be used in 2000. The Department of Justice strongly disputed these claims, arguing that the FDA used its congressional authorization to approve the drug it specified it’s secure and effective.
“This court will issue a call and opinion as soon as possible,” Kacsmaryk said at the end of the hearing.
Erik Baptist, lead attorney at Alliance Defending Freedom, told the judge he had the authority to order the FDA to initiate an internal recall process, but argued that doing so can be inappropriate on this case since it could take “a few years.”
As a substitute, Baptist argued that the court could “voluntarily” order the FDA to withdraw the drug from the market, moderately than relying on the agency to initiate internal procedures to achieve this.
“Any redress you grant, Your Honor, should be complete. The scope of this redress for plaintiffs should be universal and nationwide,” Baptist told the judge.
Kacsmaryk asked the Baptist to clarify why the court has such “enormous power”. Baptist said the court has the power to “take all measures to stop damage”. The judge also asked Baptist if he could point to a different instance of a court recall of a drug that has been on the marketplace for greater than 20 years.
“My answer to your query isn’t any, I am unable to,” Baptist said, though he argued that this was because the FDA had rejected previous petitions to withdraw mifepristone and impose tougher restrictions.
Justice Department attorney Julie Straus Harris said the statute of limitations prevents plaintiffs from difficult the FDA’s approval of mifepristone in 2000. Harris argued that an order to withdraw mifepristone from the market can be “irreparably damaged” in the public interest.
“The injunction would cause significant public harm by depriving patients and doctors of a secure and effective drug that has been on the marketplace for greater than 20 years,” Harris said. She argued that such an order would undermine the established order and harm patients, physicians, and the pharmaceutical industry’s reliance on FDA drug approvals.
Kacsmaryk sparked controversy before oral argument after The Washington Post reported that he had tried to maintain quiet about the hearing date. Citing death threats and harassment, Kacsmaryk told lawyers involved in the case that “less promoting is healthier” during a conference call last week, in keeping with a court transcript.
The court eventually relented and set the date Monday after media outlets, including the NBCUniversal News group, of which CNBC is part, filed a letter criticizing the move as “unconstitutional.”
“The Court’s try and delay notification and thus limit the ability of members of the public, including the press, to attend Wednesday’s hearing is unconstitutional and undermines the essential values that public access to court proceedings and court records serve,” wrote Peter Steffensen of Dedman School of Law at Southern Methodist University on behalf of the media.