The federal 340B program has faced criticism from pharmaceutical companies over its growth and lack of oversight. Johnson & Johnson proposed changes to the program that would require covered entities to pay full price for certain drugs and then submit rebates. However, the Health Resources and Services Administration (HRSA) deemed the proposed changes inconsistent with the statute. In response, J&J suspended the implementation of the rebate model pending resolution of the issues. Meanwhile, there were various FDA regulatory decisions including drug approvals and clinical hold updates. Pfizer voluntarily withdrew Oxbryta from the market due to safety concerns.
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J&J Backs Down From 340B Rebates, But Maintains They’re ‘Legally Permissible’ Per Statute
