Judge Refuses To Throw Out HRSA's New 340B Orphan Drug Rule; Says PhRMA 'Is Free To File' New Lawsuit

A federal District Court judge Wednesday (Aug. 27) rejected PhRMA's request that it throw out the Health Resources and Services Administration's new interpretive rule on 340B orphan drug exclusions, which is substantively identical to a rule the court vacated in May, but said the drug industry is free to file another lawsuit on the new rule. District court judge Rudolph Contreras said HRSA's July interpretive rule was a “new agency action” and therefore was not part of the Pharmaceutical Research...