FDA Quality Metrics Could Lead Market to Pay for Quality, Prevent Shortages, Woodcock Says
This article was originally published in The Gold Sheet
FDA aims to establish quality metrics that GPOs could use to choose the most robust, highest quality drug manufacturers, CDER Director Janet Woodcock says. Move could strengthen position of quality units as firms shift to compete on quality instead of price.
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One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”
High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.
Agency agrees with those who prescribe and buy drugs on need to incentivize quality. Except providers want it yesterday.