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Following a year of controversy, the Health Resources and Services Administration is taking steps to penalize six large drug makers for ending discounts to a federal program that provides medicines to hospitals and clinics serving mostly low-income populations.

In a series of letters, the agency notified Eli Lilly (LLY), Sanofi (SNY), AstraZeneca (AZN), Novo Nordisk (NVO), Novartis (NVS), and United Therapeutics that their failure to comply with the 340B drug discount program was referred to the Office of Inspector General at the U.S. Department of Health and Human Services, which oversees HRSA. If assessed, penalties can total more than $5,000 per violation.


The program requires drug makers to offer discounts that are typically estimated to be between 25% and 50% — but could be much higher — on all outpatient drugs sold to hospitals and clinics serving low-income populations. There are approximately 12,400 so-called covered entities, including 2,500 hospitals, participating in the program.

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