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in 340B Health News Releases

WASHINGTON, D.C.— Yesterday, the Health Resources & Services Administration (HRSA) referred an eighth drug company for potential fines for its continued violations of federal law requiring 340B drug pricing program discounts on eligible drugs dispensed at community pharmacies. HRSA sent a notice to Merck informing the company that the agency has referred its case to the Department of Health and Human Services Office of Inspector General (OIG). Merck is one of 18 companies that are restricting 340B pricing to safety-net providers through community pharmacy partnerships. HRSA previously referred AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Sanofi, and United Therapeutics to the OIG. HRSA has concluded these companies’ actions violate the 340B statute and is asking the OIG to determine whether the companies should receive civil monetary penalties (CMPs) for “knowingly and intentionally” overcharging 340B hospitals and other providers. If assessed, these penalties can total more than $6,000 per violation.

The following statement is attributed to 340B Health President and CEO Maureen Testoni:

“We applaud HRSA for referring Merck to the OIG for its continued refusals to follow federal law and restore 340B pricing to safety-net hospitals and health centers. Merck made nearly $49 billion in sales in 2021, driven in large part by sales of such blockbuster products as the cancer drug Keytruda, which has a list price of more than $10,000 per three-week dose. For more than a year, the company has been boosting its profits even more by depriving the health care safety net of crucial resources needed to care for patients in need.”

“The unlawful actions of these 18 companies are harming access to patient care, and they must stop. The OIG should finish reviewing the clear and convincing evidence that these companies are knowingly and intentionally overcharging hospitals and impose the steep financial fines that the 340B law requires.”

Contact: Richard Sorian at richard.sorian@340bhealth.org or 202-536-2285.