Manatt Health Partners Rachel Sher and Julian Polaris discussed the U.S. Supreme Court’s decision in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration (FDA), including its significance for access to medication abortion, as well as FDA’s authority over drug approvals more generally.
In its unanimous opinion, the Supreme Court concluded the plaintiff medical groups lacked “standing to sue” to bring this case, and so rejected an appeals court decision that would have restricted access to the medication abortion drug mifepristone through telehealth and pharmacy-based dispensing, according to a Law360 article. This unanimous decision “shows the court recognized the threat that this case posed to the integrity of the FDA drug approval system,” Sher said. Polaris added that the decision marks an example of “abortion exceptionalism”: the Court’s analysis of standing “will doubtless be very helpful to law students,” but “for lawyers who are already familiar with standing doctrine, there really isn't anything new here, which is not typically what the Supreme Court does."
Sher continued in a BioPharma Dive article, stating, “I think it shows the Supreme Court recognized the grave threat this case poses to the integrity of the entire FDA drug approval system. The court found that [AHM’s case] doesn’t demonstrate standing to challenge what was a decade’s old, scientifically-based decision by the FDA to approve this drug that has been demonstrated time and again to be safe and effective.”
Read the full Law360 articles here and here.
Read the BioPharma article here.
This news was also covered in Pink Sheet.