FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure
Friends of Cancer Research proposes realignment of medical product functions by disease area without regard to modality; former commissioners give some support but new drugs Director Jenkins warns about unintended consequences that could negatively impact innovation and approvals.
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Products like Amgen's viral therapy for melanoma could benefit under proposals to replace FDA's modality-based organization with disease-specific centers. FDA's biologics center proved itself capable of reviewing the oncologic, but the drugs center already had extensive recent experience with the fast-changing melanoma market.
Commissioner Califf says review staff reorganization based on disease will go ahead regardless of what other headway VP Biden's initiative makes.
The former commissioner says FDA has to think about getting biggest bang for the buck when considering a reorganization to disease-focused teams, particularly aimed at combination product reviews, which have been problematic because the drug and device review schedules often do not mesh.