SIX DRUG COMPANIES REFERRED FOR PENALTIES FOR CONTINUED VIOLATIONS OF FEDERAL LAW ON 340B PRICING
WASHINGTON, D.C., SEPT. 22, 2021— Earlier today, the Health Resources & Services Administration (HRSA) referred six drug companies for potential fines for their continued violations of federal law requiring 340B drug pricing program discounts on eligible drugs dispensed at community pharmacies.
HRSA sent notices to Eli Lilly, AstraZeneca, Novartis, Novo Nordisk, Sanofi, and United Therapeutics informing them that the agency had referred their cases to the Department of Health and Human Services Office of Inspector General (OIG). The matter involves the companies’ ongoing refusals to offer 340B pricing to safety-net providers through community pharmacy partnerships. HRSA has concluded these actions violate the 340B statute, and the OIG now will determine whether the companies are liable for civil monetary penalties (CMPs) for “knowingly and intentionally” overcharging 340B hospitals and other providers. If assessed, these penalties can total more than $5,000 per violation.
The following statement is attributed to 340B President and CEO Maureen Testoni:
“The safety-net hospital community applauds HRSA for taking this crucial enforcement step against drug companies that are denying 340B discounts to covered entities. Despite unequivocal determinations from the government that these drugmaker actions are unlawful, the companies continue to ignore federal law and refuse to offer 340B pricing on drugs dispensed at community pharmacies. We ask the OIG to undertake an expeditious review of the substantial evidence that these companies are knowingly and intentionally overcharging safety-net providers.”
“The longer these drugmakers refuse to follow the law, to stop overcharging for 340B drugs, and to repay the denied savings, the greater the harm will be to patient care. This must end.”
Contact: David Glendinning at david.glendinning@340bhealth.org or 202-536-2289.