340B Program: Orphan Drug Exception—A Timeline of PhRMA's Legal Challenge to HRSA's Final Rule

On Wednesday, August 27, 2014, the U.S. District Court for the District of Columbia entered final judgment in the legal challenge to the final rule on the treatment of orphan drugs under the 340B Drug Pricing Program. That legal challenge, commenced in September 2013, followed a circuitous route that involved not only court filings but also public remarks by a government official—and their subsequent retraction. The following timeline outlines important events related to the legal challenge and includes links to relevant filings and other documents.

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