The Alliance for Hioppocratic Medicine’s lawsuit seeking to force the Food and Drug Administration to revoke its approval of mifepristone, a widely used abortion medication, has received significant attention. (I’ve blogged on administrative law issues in the case here and here.) Less attention has been made to a parallel lawsuit filed by Demoratic state attorneys general seeking to force the FDA to move in the opposite direction.
Lawyers representing the FDA are expected in court on Tuesday to defend the agency’s authority to place certain restrictions on mifepristone, which is typically used to end a pregnancy during the first 10 weeks. The case before the U.S. District Court for the Eastern District of Washington was brought by more than a dozen Democratic state attorneys general who say the requirements around the drug, including a certification process for anyone prescribing it, place an undue burden on patients and providers. . . .
Oregon Attorney General Ellen Rosenblum is co-leading the lawsuit with Ferguson, and they are joined by the Democratic attorneys general representing Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.
The pill restrictions, the group claims, are burdensome for both patients and doctors and the documentation requirements put them at risk for harassment or violence.
Interestingly enough, this lawsuit faces some of the same administrative law obstacles as does the AHM suit. As the Justice Department points out in its brief, the state AGs failed to administratively exhaust their remedies before filing suit (such as by filing a petition calling upon the FDA to alter its regulation of mifepristone). Moreover, it is not clear how the state AGs have standing to raise their claims at all. The state AGs’ claims that their states are harmed by the maintenance of restricitons on prescribing mifepristone rest on speculative claims about the effect of such restrictions.
Another problem with the state AGs’ suit is that it is ostensibly challenging the mifepristone restrictions adopted by the FDA in January 2023, but those restrictions represented a loosening of the FDA’s restrictions on mifepristone. Accordingly, vacating the January 2023 policies would result in the reimposition of those restrictions previously in force, which would be more burdensome and thus do more harm to the interests the state AGs purport to represent.
As I understand it, this lawsuit was filed to try and blunt the impact of AHM v. FDA, either by creating a conflicting court order or nationwide injunction that would keep mifepristone on the market or merely by creating a circuit split on the question. Yet whatever the motivation of the suit, it seems to me it should founder on some of the same administrative law grounds that could frustrate the AHM case.
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