Richie Davis and Michael French Quoted in 340B Report Article on Johnson & Johnson’s Contested 340B Rebate Proposal
Richie Davis and Michael French, attorneys in the firm’s Health & Life Sciences Practice Group, were quoted in a 340B Report article on Johnson & Johnson’s contested 340B rebate proposal.
Davis and French discuss how Johnson & Johnson has not received government approval and that its policy is inconsistent with the 340B statute. They further comment that while the U.S. Department of Health and Human Services (HHS) has the authority to approve alternative rebate or discount models, it already has publicly rejected Johnson & Johnson’s proposed model.
An excerpt:
Multiple attorneys and provider advocates agreed with HRSA’s position that J&J’s rebate model was “inconsistent” with the 340B statute, while a drug industry consultant who until recently practiced law representing drug manufacturers told340B Report that J&J’s policy would likely hold up against a potential HRSA challenge.
J&J’s proposed rebate policy “appears to be squarely inconsistent with the 340B statute, which expressly requires that a manufacturer offer covered outpatient drugs‘ for purchase’ at or below the 340B ceiling price,” said Richard Davis and Michael French, attorneys Quarles, a law firm that represents 340B covered entities, pharmacies, wholesalers, and other industry stakeholders.
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“A plain reading of this statutory section indicates that the 340B price must be offered up front at the time the covered entity is actually buying the drug, and not through a retroactive rebate process,” Davis and French told 340B Report. “While the statute ostensibly gives [the U.S. Department of Health and Human Services (HHS)]the authority to approve alternative ‘rebate’ or ‘discount’ models, HHS has already publicly rejected J&J’s proposed model.”