Abortion rights supporters gather in front of the J Marvin Jones Federal Building and Courthouse on March 15, 2023 in Amarillo, Texas.
Moises Avila | AFP | Getty Images
A federal judge in Texas this week heard arguments for the first time 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.
Judge Matthew Kacsmaryk of the US Northern District of Texas in Amarillo heard arguments for four hours. 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 attorneys who defended the FDA, and then abortion pill maker Danco Laboratories.
The Alliance Defending Freedom argued that mifepristone was unsafe and the FDA did not properly follow its approval process when clearing mifepristone for use in 2000. The Justice Department strongly denied these claims, arguing that the FDA used its Congressional-approved powers to approve a drug it determined is safe and effective.
Download a full copy of the hearing transcript here.
“This court will issue a decision and an opinion as soon as possible,” Kacsmaryk said at the end of the hearing.
Erik Baptist, Alliance Defending Freedom’s top attorney, told the judge he had the authority to order the FDA to begin its internal process to withdraw a drug from the market, but argued that such action would be inappropriate in this case because it the case could last “many years”.
Instead, Baptist argued that the court could “of its own accord” order the FDA to withdraw the drug, rather than relying on the agency to initiate its internal procedures to do so.
“Any relief you grant, Your Honor, must be complete. The plaintiffs’ scope of this relief must be universal and nationwide,” Baptist told the judge.
Kacsmaryk asked Baptist to explain why the court had such “broad authority.” Baptist said the court has the authority to “take all measures necessary to prevent harm.” The judge also asked Baptist if he could point to another case where a court had withdrawn a drug that has been on the market for more than 20 years.
“My answer to your question is no, I can’t,” Baptist said, although he argued that this was because the FDA had denied previous requests to withdraw mifepristone and impose tighter restrictions.
Julie Straus Harris, a Justice Department attorney, said the statute of limitations prevented plaintiffs from challenging the FDA’s 2000 approval of mifepristone. Harris argued that the public interest would be “irreparably harmed” by an order to take mifepristone off the market.
“An injunction would cause significant harm to the public and deprive patients and physicians of a safe and effective drug that has been on the market for more than two decades,” Harris said. She argued such an order would upend the status quo and harm patients, physicians and the pharmaceutical industry’s reliance on FDA approvals.
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Kacsmaryk sparked controversy ahead of oral arguments after the Washington Post reported that he had tried to keep news about the hearing’s timing private. Citing death threats and harassment, Kacsmaryk told lawyers involved in the case that “less publicity is better” during a conference call last week, according to a court transcript.
The court finally relented and announced the date Monday after media outlets, including NBCUniversal News Group, which owns CNBC, filed a letter criticizing the move as “unconstitutional.”
“The court’s attempt to delay notification and thereby the ability of the public, including the press, to attend Wednesday’s hearing is unconstitutional and undermines the important values served by public access to court proceedings and court records,” he wrote to Peter Steffensen of Southern Methodist University’s Dedman School of Law on behalf of the media.
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