Defending Access to FDA-Approved Pharmaceuticals

Patient and provider groups including ACS CAN applauded the unanimous U.S. Supreme Court decision in Alliance for Hippocratic Medicine v Food and Drug Administration (FDA), which preserved the agency’s approval of the drug mifepristone.  The Court’s ruling was based on legal standing, finding the plaintiff doctors and their association could not prove damages in the case.  ACS CAN had joined an amicus brief at the US Supreme Court on the merits of the case as well as an amicus urging the high court to accept the petition prior. The briefs underscored the importance of deference to FDA’s scientific expertise in its determinations in drug approvals, and citical patient reliance on approved therapies.  The case is not over, however, as some states were permitted to intervene at the district court level and those plaintiffs were not in front of the Supreme Court in its  decision.

Mifepristone, which is used in many medical abortions, was approved by the FDA in 2000.  In 2016, the agency updated and approved a new evidenced-based regimen that expanded access to the drug.  Unfortunately, a district court stayed approval in 2023. The decision was put on partial hold by the US Court of Appeals for the Fifth Circuit, but then stayed in its entirety by the US Supreme Court, meaning it remains on the market throughout the course of the litigation.

The case has sweeping implications if it allows courts to undercut FDA’s scientific expertise when reviewing and approving products, posing a significant risk to the cancer patients ACS CAN represents. Allowing plaintiffs to undermine scientific determinations made by the agency could jeopardize access to any FDA-approved medications and other treatments. The result: patient access to evidence-based care would be compromised by shifting decisions about drug safety to judges, rather than the experts in science and medicine best equipped to determine the safety and efficacy of drugs and treatments.

ACS CAN and more than 30 other patient groups issued a statement of support when the US Supreme Court issued its stay on the lower courts’ orders, and both ACS and ACS CAN joined an amicus brief filed at the Fifth Circuit to help educate the court about the drug approval process and patients’ critical need to access approved therapies.