US FDA Looks To Proactively Update Old Generic Drug Labels Under Pilot
Concept mentioned during Gottlieb’s 'star' turn at Davos may sound similar to now-withdrawn generic labeling rule, but actually appears based on a proposal from the Friends of Cancer Research to get current clinical guidelines reflected on labels.
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Under the Oncology Center of Excellence’s Project Renewal, agency has contracted with consulting firm Deloitte to establish subject matter expert research teams that will review published literature on off-patent drugs and suggest labeling updates.
Label updates for older generics are still planned, Commissioner Gottlieb says, but will depend more on sponsor collaboration as well as additional resources and authorities from Congress.
Agency has targeted 40 older generic chemotherapeutics for revised labeling; FDA will develop the new labeling, which will include currently accepted uses, but needs the cooperation of reference product holders who would actually have to submit the supplement.