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America’s Essential Hospitals Supports Orphan Drug Rule

America’s Essential Hospitals and two other national organizations filed an amicus brief Dec. 20, 2013, supporting the Health Resources and Services Administration’s (HRSA’s) final rule allowing hospitals to purchase certain drugs at discounted prices through the 340B Drug Pricing Program.

The July 22, 2013 final rule stated that new covered entities added to the 340B program under the Affordable Care Act (ACA)—i.e., critical access hospitals, rural referral centers, sole community hospitals, and freestanding cancer hospitals—may receive 340B discounts on orphan drugs when the drugs are used for a disease or condition outside of the indication for which the drugs received their designation. Drugs designated as “orphan” are intended to treat, diagnose, or prevent rare diseases or disorders.

In their amicus brief, America’s Essential Hospitals, Safety Net Hospitals for Pharmaceutical Access, and the National Rural Health Association argued that the U.S. District Court for the District of Columbia should deny a request from the Pharmaceutical Research and Manufacturers of America for a preliminary injunction to bar implementation of the rule.

While the groups said that the rule is consistent with the ACA’s language, regardless, HRSA’s interpretation is reasonable because it is consistent with the intent of the 340B statute, which is to support providers that treat vulnerable patients. They noted that the rule is also consistent with HRSA’s application of the orphan drug designation in other contexts, in which it is also treated in a disease-specific, rather than drug-specific, manner. The groups also said an injunction would increase hospital drug costs, which could lead to “reduced services and increased costs for patients.”


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