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340B Orphan Drug Policy Is Binding On Manufacturers – HRSA

This article was originally published in The Pink Sheet Daily

Executive Summary

Despite a court’s ruling that the Health Resources and Services Administration does not have authority to issue an orphan drug rule for the 340B drug discount program, HRSA’s Krista Pedley says the agency considers its interpretation of the statue to be binding on manufacturers, so that they are required to offer discounts on non-orphan uses of orphan-designated drugs.

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