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End Delay of 340B Program Ceiling Price, Civil Monetary Penalties Rule


WASHINGTON—We find entirely unacceptable today’s decision by the Health Resources and Services Administration (HRSA) to put off for more than a year rules to protect patients and hospitals from drug company overcharges.

Federal scrutiny of manufacturer pricing practices has found overcharges in the 340B Drug Pricing Program. These overcharges undermine the program’s ability to make drugs affordable for vulnerable patients and increase costs for their hospitals, which already operate with thin margins.

We have waited too long for simple measures to hold drugmakers accountable in the 340B program. Hospitals and other covered entities comply with significant program oversight, including more than 800 federal audits since 2012. Manufacturers have faced only 11 audits since 2015.

We need to level the playing field, and these rules on ceiling prices and civil monetary penalties are a reasonable first step toward that goal. We call on HRSA to revisit its decision and put these rules in place immediately.

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Carl Graziano


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