On February 10, 2025, WLF urged the District Court for the District of Columbia to reject HRSA’s position that drug manufacturer Johnson & Johnson cannot use a rebate model to provide 340B pricing to certain hospitals. In its amicus brief supporting Johnson & Johnson, WLF argued that HRSA’s recent threatened enforcement action improperly expands 340B’s well-intended cost-reduction program far beyond anything its statutory text can sustain. According to HRSA, a drug manufacturer must receive pre-approval from the agency before employing a 340B pricing model. But this claim is belied by the text of 340B, which requires no such pre-approval. Moreover, HRSA’s argument goes against its own historical 30-year practice of tacitly approving various 340B-compliant pricing models without requiring pre-approval. WLF’s amicus brief was prepared with generous pro bono assistance from Thad Westbrook and Jeff Wald of Nelson Mullins.
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