HRSA Releases New 340B Orphan Drug Rule; PhRMA Views Move As 'Power Play'

The Health Resources and Services Administration on Monday (July 21) issued an interpretive rule, expected by stakeholders, restating its view that orphan drugs used for non-orphan purposes are subject to 340B drug discounts -- a move the drug industry views as a “government power play” to get around a court ruling in PhRMA's favor and has asked the court to step in. Pharmaceutical Research and Manufacturers of America said in a court brief filed Friday (July 18) that regardless of...