publication date: Jun. 20, 2014


By Tessa Vellek

The Health Resources and Services Administration said it stands by its interpretation of the Affordable Care Act orphan drug exclusion, despite a recent court ruling that challenged its authority to engage in legislative rulemaking.

The ruling may have implications on another HRSA legislative rule, the “mega-rule,” which would clarify many of the fundamental definitions in the controversial 340B Drug Discount Program (The Cancer Letter, June 13).

Federal Judge Rudolph Contreras of the U.S. District Court of the District of Columbia vacated HRSA’s attempt to expand the 340B drug discount program to include some uses of orphan drugs May 23.

HRSA released a statement on its website June 18, reaffirming its original interpretation, regardless of the court ruling.

“The Court did not invalidate HRSA’s interpretation of the statute,” the statement reads. “HHS/HRSA continues to stand by the interpretation described in its published final rule, which allows the 340B covered entities affected by the orphan drug exclusion to purchase orphan drugs at 340B prices when orphan drugs are used for any indication other than treating the rare disease or condition for which the drug received an orphan designation.”

In addition, HRSA urged hospitals that take part in the 340B program to follow their posted guidelines for using discounts to purchase orphan drugs for non-orphan indications.

“HRSA…posted the Orphan Drug Designation List and the Orphan Selection File in order to assist the 340B stakeholders with complying with HRSA’s policy before the new quarter start July … Continue reading 40-25 HRSA Defends 340B Orphan Drug Rule

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