Novo Files Suit Over IRA As It Joins Others In Signing On To Price Negotiations
The nine drug manufacturers with products selected for Medicare drug price negotiations have agreed to participate in the program. Seven of them now have pending suits challenging the Inflation Reduction Act program with Novo’s recent complaint, which objects to the aggregation of its insulin products.
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Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.
People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.
Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.