[Ip-health] HHS to Move Forward With 340B Drug Rule on Orphan Drugs

Sean Michael Flynn sflynn at wcl.american.edu
Wed Jun 18 15:38:38 PDT 2014

HHS to Move Forward With 340B Drug Rule
Posted June 18, 2014, 2:45 P.M. ET
BNA, Inc. Pharmaceutical Law & Industry Report - Breaking News
The Department of Health and Human Services June 18 said it plans to move
forward with a rule that allows hospitals participating in the 340B
program to purchase discounted ³orphan² drugs when the drugs aren't used
to treat a rare disease or condition, despite a recent court ruling that
the agency didn't have the authority to do so.
In May, Judge Rudolph Contreras vacated the HHS rule authorizing discounts
for rare-disease, or orphan, drugs bought by certain safety-net providers,
finding that there wasn't any statutory authority for the HHS orphan drug
But the court said it would consider the HHS's alternative request to
uphold the rule as interpretive rather than legislative if the agency
submitted additional briefing for the court to consider. On June 12, the
HHS said it wouldn't submit additional briefing in the case.
In the June 18 statement
>, HHS and the Health Resources and Services Administration (HRSA) said
>they continue to stand by the interpretation described in the 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 of
>condition for which the drug received an orphan designation.

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