J&J Sues US Government Over Blocked 340B Rebate Plan, Seeking Judicial Approval

J&J's proposed rebate plan aimed to substitute upfront discounts with post-purchase rebates for hospitals purchasing certain drugs, including Stelara and Xarelto, through the 340B Drug Pricing Program[1][2]. The plan was intended to be implemented only for a subset of hospitals responsible for the majority of 340B purchases, emphasizing the verification of hospitals’ drug purchases and dispensing records to ensure program compliance[2]. Despite these intentions, HRSA blocked the proposal, leading J&J to file a lawsuit seeking judicial approval, citing the benefits of improved transparency and reduction of program misuse, such as duplicate discounts[1]. The company argues that their rebate model would mitigate risks and comply with goals to enhance program integrity[1].