340B Manufacturer Fines Outlined In Rule, But HRSA Expects To Use Them ‘Very Rarely’
This article was originally published in The Pink Sheet Daily
Proposed rule would implement how civil monetary penalties will be applied to manufacturers that “knowingly and intentionally” deny 340B prices to eligible health care providers.
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Pharma pushback pays off as HRSA requests additional public comment on key issues, including 340B ceiling prices and manufacturer civil monetary penalties.
HRSA's proposed rule on civil monetary penalties conflicts with statute's requirement that penalties be imposed only for knowing and intentional program violations, trade groups say.
Manufacturers pinpoint flaws in and outline alternatives to HRSA's plan to codify the now non-binding policy of charging a penny per pill for certain products. Concerns are raised about stockpiling and drug diversion, in addition to fair payment.