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Expert Analysis

PhRMA V. HHS Scales Back HRSA Rulemaking Power

Law360, New York (June 10, 2014, 12:08 PM EDT) -- On May 23, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia ruled[1] that the Health Resources and Services Administration ("HRSA") did not have the statutory authority to promulgate its orphan drug final rule.[2] HRSA's Rule, "Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program," implemented a provision of the Affordable Care Act that excludes orphan drugs from 340B pricing for the covered entities added to the 340B program by the ACA.[3] Under the final rule, orphan drugs were excluded from the 340B ceiling price only when the drugs were used for the indication for which they were granted the orphan designation....

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