HRSA's Sanctions Warning to J&J Over 340B Rebate Scheme
Critical Response from HRSA Regarding J&J's 340B Modifications
The U.S. Health Resources and Services Administration (HRSA) has sent a stern warning to Johnson & Johnson, insisting the company discontinue its planned changes to the 340B drug pricing program. If J&J fails to scrap its proposed operational adjustments, it risks termination from the program and substantial monetary penalties.
Consequences of Non-Compliance
- Potential termination of J&J's participation in the 340B program.
- Possible civil monetary penalties for violations.
In its communication, HRSA highlighted that unless J&J adheres to its original obligations within the program, the consequences will be significant. As per HRSA's announcement, drug manufacturers, including J&J, must fully understand their responsibilities under the 340B statute.
Details of the Proposed Changes
- J&J plans to implement a new pricing strategy, requiring hospitals to purchase drugs at full price.
- Rebates are contingent upon retrospective validation of the purchase.
- This change affects key products, including Xarelto and Stelara.
Notably, hospitals seeking rebates would need to submit requests promptly, reflecting J&J's stringent new requirements. HRSA's communication follows J&J's announcement of these sweeping modifications, which are set to take effect on October 15, 2024.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.