- Judge Matthew Kacsmaryk of the U.S. Northern District of Texas heard oral arguments this week in a case challenging FDA approval of mifepristone.
- The hearing in Amarillo on Wednesday was open to the public but it was not livestreamed.
- You can read a full transcript of the hearing here.
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 on Wednesday was open to the public but it was not livestreamed.
Judge Matthew Kacsmaryk of the U.S. Northern District of Texas in Amarillo heard four hours of arguments. The anti-abortion group that filed the lawsuit, the Alliance Defending Freedom, presented their case against the FDA first. They were followed by Justice Department attorneys defending the FDA and then the abortion pill maker Danco Laboratories.
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The Alliance Defending Freedom argued that mifepristone is unsafe and the FDA did not properly follow its approval process when it cleared mifepristone for use in 2000. The Justice Department strongly disputed those claims, arguing the FDA used its congressionally authorized powers to approve a drug it determined is safe and effective.
Download a full copy of the hearing transcript here.
"This Court will issue an order and opinion as soon as possible," Kacsmaryk said at the hearing's conclusion.
Erik Baptist, the top attorney at Alliance Defending Freedom, told the judge that he has the authority to order the FDA to initiate its internal process to withdraw a drug from the market, but argued that such an action would be inappropriate in this case because it could take "many years."
Instead, Baptist argued the court can "on its own accord" order the FDA to withdraw the drug from the market rather than relying on the agency to initiate its internal procedures to do so.
"Any relief that you grant, Your Honor, it must be complete. The scope of plaintiffs'--of this relief needs to be universal and nationwide," Baptist told the judge.
Kacsmaryk asked Baptist to explain why the court has such "sweeping authority." Baptist said the court has the power to "take whatever action to prevent harm." The judge also asked Baptist if he could point to any other case of a court withdrawing a drug that's 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 this is because the FDA stonewalled previous petitions to pull mifepristone and impose tougher restrictions.
Julie Straus Harris, an attorney from the Justice Department, 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 pulling 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 such an order would upend the status quo and harm patients, doctors and the pharmaceutical industry's reliance on FDA drug approvals.
Kacsmaryk sparked controversy prior to oral arguments after The Washington Post reported that he sought keep news of the hearing's date quiet. Citing death threats and harassment, Kacsmaryk told attorneys involved in the case that "less advertisement is better" during a telephone conference call last week, according to a court transcript.
The court ultimately 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 Court's attempt to delay notice of 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 served by public access to judicial proceedings and court records," wrote Peter Steffensen of Southern Methodist University's Dedman School of Law on behalf of the media outlets.