On January 30, 2023, the Third Circuit rejected the Health Resources Services Administration’s (HRSA) claim under the 340B Program to broad regulatory authority that Congress never gave it. The appeal arose from a suit by prescription-drug manufacturer AstraZeneca against HRSA, challenging the agency’s recent enforcement action under the 340B Program. As the Third Circuit rightly concluded, HRSA’s recent regulatory overreach has no statutory support. “Congress never said that drug makers must deliver discounted Section 340B drugs to an unlimited number of contract pharmacies,” the court announced. “So by trying to enforce that supposed requirement, the government overstepped the statute’s bounds.” The court’s opinion largely tracks statutory arguments found in WLF’s amicus brief, which accused HRSA of trying to unilaterally transform the 340B Program from “a sensible cost-saving measure” into “a constitutionally dubious wealth-transfer scheme.”


Third Circuit opinion

WLF amicus brief