Association member The University of Washington Medical Center, in Seattle, on Oct. 22 filed suit against the Health Resources and Services Administration (HRSA) for failing to comply with its guidelines for approving an audit request from pharmaceutical manufacturer Johnson & Johnson (J&J) under the 340B Drug Pricing Program.
This hospital joins four other hospitals that have independently sued HRSA for failing to comply with audit request approval guidelines, including association member Oregon Health & Science University, Children’s National Medical Center, the University of Rochester, and MaineGeneral Medical Center.
HRSA audit guidelines require manufacturers to offer 340B covered entities a 30-day window to resolve a suspected infraction in good faith before conducting an audit. Each hospital has alleged that HRSA inappropriately approved the manufacturer audit request after J&J’s failure to offer a good-faith resolution period. The University of Washington Medical Center additionally alleges that HRSA approved J&J’s audit request on an accelerated timeline, faster than the two-week window outlined in HRSA guidelines.
The hospitals each request an injunction, awarding of costs, and any further relief the court deems proper.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.