HRSA Defines "Orphan Drug" For 340B; Purchasing Prohibition Applies Only To Use In Rare Diseases
This article was originally published in The Pink Sheet Daily
Executive Summary
Manufacturers and safety net providers have been uncertain on how to interpret the Affordable Care Act's provision excluding orphan drugs from 340B discounts to newly eligible types of facilities.
You may also be interested in...
340B Final Rule Keeps Orphan Drug Exclusion Narrow, Counter To Manufacturers’ Request
HRSA’s final rule on the exclusion of orphan drugs from 340B discounts says the exclusion applies only to the FDA-designated orphan indication, not all uses of a drug with a rare-disease designation.
Bipartisan Bill Expanding 340B Discounts To Inpatient Drugs Introduced In House
Bill would also repeal the ban on 340B discounts for orphan drugs purchased by rural and free-standing cancer hospitals.
Bipartisan Bill Expanding 340B Discounts To Inpatient Drugs Introduced In House
Bill would also repeal the ban on 340B discounts for orphan drugs purchased by rural and free-standing cancer hospitals.