DoJ Formally Appeals Mifepristone Texas Order
The Department of Justice (DoJ) has officially appealed Texas federal judge Matthew J. Kacsmaryk’s 4/7 controversial court order (see earlier story) to undo FDA’s 2020 approval of mifepristone (Mifeprex). The 4/10-filed emergency motion to the Fifth Circuit Court of Appeals urges the court to immediately extend the current seven-day administrative stay and then stay Kacsmaryk’s order pending appeal.
DoJ’s filing argues that the lower court erred in holding that plaintiffs have standing. “Their asserted injuries rest on a ‘highly attenuated chain of possibilities’ that falls far short of demonstrating injury-in-fact,” it says. It takes issue with the court concluding that the plaintiff organizations have standing to sue on behalf of their members because they allege adverse events from mifepristone can overwhelm the medical system.
“But plaintiffs rely on only a handful of alleged incidents over two decades, none of which meaningfully interfered with a member’s medical practice,” the motion continues. “Under the court’s approach, doctors would have standing to challenge FDA approval of any drug; they would likewise have standing to challenge any other federal action that might injure third parties. An association of doctors could, for example, challenge the licensing of federal firearms dealers, or allegedly inadequate highway safety standards, on the theory that some individuals may be injured and seek treatment from the association’s members.”
DoJ’s motion also says Kacsmaryk’s order erred by holding that plaintiffs’ claims are timely. Claims brought by the plaintiffs have a six-year statute of limitations, but FDA approved the drug in 2000 and denied the plaintiff’s 2002-filed citizen in 2016. The court erred, DoJ says in concluding that FDA reopened those decisions and thereby restarted the statute of limitations when it modified the conditions of use, including the risk evaluation and mitigation strategies, in 2016.
Additionally, the DoJ appeal says the lower court “erred by overriding FDA’s eminently reasonable scientific judgments based on the court’s own interpretation of articles and studies, including many submitted by plaintiffs or their amici to the court but not to FDA. For example, in concluding that no women should have access to mifepristone because it is harmful to them, the court relied on an article that was based entirely on fewer than 100 anonymous blog posts submitted to a Website titled Abortion Changes You…”
And, the government’s filing argues that the lower court “fundamentally misunderstood” FDA’s accelerated approval authority. “FDA found that pregnancy 'can be a serious medical condition in some women,' and mifepristone avoided a surgical procedure for 92% of patients,” it says. “The court reasoned that pregnancy is not an ‘illness,’ but the preamble to FDA’s final rule explained that Subpart H [accelerated approval] was available for drugs that treat serious or life-threatening conditions… And while the court disagreed that avoiding a surgical procedure is a ‘meaningful therapeutic benefit,’ FDA reasonably determined that it is for many patients.”