Drug Shortage Senate Draft: FDA Told To Look For Impact Before Leaping Into Enforcement
Proposal would require shortage consideration before FDA issues an enforcement action, which could ensure enforcement and shortage staff continue talking.
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CDER director says SPLMU proposal could open up antibiotics for resistant pathogens to orphan drug incentives, which could help prime the anemic development pipeline.
Democratic Senator has terse exchange with FDA at hearing and says Congress must do more than what is already in pending legislation. Blumenthal said he is willing to consider the Generic Pharmaceutical Association proposal calling for an independent third party to compile supplier data and predict coming shortages.
FDA would have 60 days to review major changes and could “deem” them compliant with current good manufacturing practices so long as the facility has a plan and resources to achieve full compliance and institutes quality control measures under draft legislation being developed by the House Energy and Commerce Committee.