CORRECTED: HHS Sets Final Rule For Orphan Drugs Under 340B Program

Law360, Washington (July 22, 2013, 6:41 PM EDT) -- The U.S. Department of Health and Human Services is set to issue a final rule Tuesday that will detail how hospitals participating in the 340B drug-discount program can acquire so-called orphan drugs for cheaper prices, setting down guidelines that balance hospital and patient access with manufacturers' rights.

Under the 340B program, drug manufacturers are required to sell outpatient drugs at deep discounts to safety-net hospitals, such as those that care for a disproportionate share of poor patients. The program has long prohibited certain hospitals — disproportionate...
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