Pharmaceutical manufacturer Novartis on Jan. 15 filed a lawsuit in federal court against the Health Resources and Services Administration (HRSA), requesting the court authorize the company’s proposed rebate model for the 340B Drug Pricing Program.
Novartis asks the court to grant the manufacturer permission to require that disproportionate share hospital covered entities purchase all Novartis manufactured products at list price and only achieve the 340B ceiling price after the product has been dispensed. The suit makes Novartis the fifth manufacturer — joining Johnson & Johnson, Eli Lilly, Bristol-Myers Squibb, and Sanofi in separate lawsuits to allege that HRSA violates federal statute for prohibiting manufacturers from making unilateral changes to the 340B program.
Novartis requested permission from HRSA to implement a rebate model, which the agency declined, the filing says. Novartis argues that statute permits rebate models, as they already are used for state-managed AIDS Drugs Assistance Programs. Novartis alleges that HRSA is being “arbitrary and capricious” in denying the request. The manufacturer asks the court to authorize the model and provide injunctive relief to bar the agency from acting against implementation.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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