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FDA Priority Review For Some Generics Urged To Address 'Market Failure'

 
• By Cathy Kelly

Senate Aging Committee hearing addresses generic drug priority reviews at FDA, compounding and publicizing a “watch list” of off-patent drugs with no competition as ways of deterring dramatic price increases for such products.

FDA should be able to establish a priority review process for generic drugs where there is minimal price competition for an off-patent drug, Gerard Anderson, professor of health policy and management at Johns Hopkins University, told the Senate Special Committee on Aging at a Dec. 9 hearing.

Such an approach would help to deter drug firms like Turing Pharmaceuticals AG and Valeant Pharmaceuticals International Inc. from purchasing an older off-patent drug that has no generic...

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