Judge Matthew Kacsmaryk of the U.S. Northern District of Texas heard oral arguments this week in a case challenging FDA approval of mifepristone.
You can read a full transcript of the hearing here.
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."This Court will issue an order and opinion as soon as possible," Kacsmaryk said at the hearing's conclusion.
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. 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.
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