Simplifying Global Compliance
FDAnews Drug Daily Bulletin
Rule Allows 340B Discounts on Some Orphan Drugs
Aug. 5, 2013
HHS has published a final rule specifying that orphan drugs are no longer entirely excluded from cost savings under the 340B program. The exclusion now applies only when used for the rare disease for which it received the designation, a move championed by hospitals and clinics but criticized by a pharmaceutical industry already unhappy with the federal discount-drug program.
Washington Drug Letter
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