Defending Access to FDA-Approved Pharmaceuticals

February 5, 2024

A U.S. District Court decision out of Texas in the case of Alliance for Hippocratic Medicine v Food and Drug Administration (FDA)  stayed the agency’s approval of the drug mifepristone, which is used in many medical abortions. 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.

Mifepristone 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, in August of 2023, the Fifth Circuit ruled to reinstate pre-2016 restrictions.

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. PDF iconACS and ACS CAN joined an amicus brief filed at the US Supreme Court urging the Court to hear the government’s appeal of the case. Read our statement. After the US Supreme Court accepted the case, ACS and ACS CAN PDF iconjoined another amicus brief on the merits, providing the high court with similar background to the Fifth Circuit. Read our statement on our latest Supreme Court filing in the case.