HHS Targets Six Drugmakers Over 340B Noncompliance

September 28, 2021

The Health Resources and Services Administration (HRSA) has sent letters to six pharmaceutical companies — AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi, and United Therapeutics — letting them know their failure to comply with the 340B drug discount program has been referred to the Office of Inspector General at HHS.

The move signals HHS getting serious about hitting the companies with penalties for their actions. The letters come five months after HRSA warned the drugmakers that they would be charged with fines of $5,000 per violation if they continued to decline to offer the discounts.

Under the 340B program, pharmaceutical manufacturers extend lower pricing to hospitals and clinics that treat significant numbers of low-income patients. The discounts are estimated at 25 percent to 50 percent.

Over the past 12 months, the six drugmakers and others began to disregard the 340B program, saying that duplicate orders and faulty rebates in the system, among other factors, justified their actions. They have issued statements, refuting the reference to the OIG.

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