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HRSA Issues Follow-Up Letters to Drug Manufacturers in Violation of 340B Statute

September 24, 2021

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CONTACTS
Ivy Baer, Senior Director and Regulatory Counsel

On Sept. 22, the Health Resources and Services Administration (HRSA) sent follow-up letters to six pharmaceutical manufacturers that announced they would no longer supply 340B drugs that are dispensed through contract pharmacies at or below the 340B ceiling prices.

The letters state that “continued failure to provide the 340B price to covered entities utilizing contract pharmacies could result in civil monetary penalties.” Since the companies have failed to comply, the letters inform each company that HRSA has referred the issue to the Department of Health and Human Services (HHS) Office of Inspector General, which has the authority to impose civil monetary penalties. The penalty is not to exceed $5,000 per instance of overcharging.

HRSA had sent letters in May informing each manufacturer that they are in “direct violation of the 340B statute” by restricting “340B pricing to covered entities that dispense medications” through community pharmacies [refer to Washington Highlights, May 21].

The AAMC, along with four other hospital organizations, previously filed a lawsuit against HHS over the agency’s failure to prevent drug manufacturers from withholding 340B prices when the drugs are distributed at community pharmacies [refer to Washington Highlights, Dec. 18, 2020].

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