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HRSA Tells Drugmakers To Repay Hospitals for 340B Orphan Drug Overcharges

Agency says companies are not following the law or their agreements with the government
 

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October 16, 2014—The Health Resources and Services Administration has told an undetermined number of orphan drug manufacturers that they are out of compliance with 340B statutory requirements and their pricing agreements with the government and must notify it of their plans to repay affected rural and freestanding cancer hospitals for overcharges. It is HRSA’s most significant enforcement action affecting drug manufacturers in the 340B program’s 22-year history. 


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