Johnson & Johnson proposed significant changes to the 340B program that would require eligible hospitals to pay full prices for medications first, then claim rebates for discounts. This drew sharp criticism from HRSA, which denounced the proposal as inconsistent with the statute. J&J contended it was necessary to prevent duplicate discounts, but faced strong backlash and potential consequences.
The Health Resources and Services Administration expressed concerns that J&J's proposed changes violated the 340B statute, warning that moving forward with the rebate would result in termination of J&J's pricing agreement. This indicates the strict regulatory environment that governs the program and the importance of adherence to its rules by drug manufacturers.
Despite facing pressure from pharmaceutical companies, the 340B program's aim has remained focused on assisting underserved communities by allowing significant discounts on outpatient medications, which serves as a crucial lifeline for hospitals and clinics serving low-income patients.
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