Once again, the 340B Drug Pricing Program is at the center of a controversy. The latest flap involves discounts that the US Health Resources and Services Administration established for a select group of hospitals in order for them to obtain orphan drugs, which are medications that were approved by the FDA to treat rare diseases. An HRSA rule governing orphan drug discounts went into effect this week. In response, the PhRMA trade group has filed a lawsuit against HRSA and accused the agency of erroneously interpreting a provision of the Affordable Care Act that defines the extent of the discounts to be made available for orphan drugs.
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