Drug Shortages Endgame: FDA Goes On Offensive As Legislative Plot Thickens
FDA press conference on alleviating shortages shows how the agency works with industry to advance legislation that firms may not be particularly fond of themselves. But the agency still seems to face an uphill legislative battle.
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The public’s acceptance of generic drugs is at an all-time high. But manufacturing issues, shortages of life-saving medications and questions about the overall quality of generics are testing the system like never before. FDA’s tough love message to industry: fix the manufacturing problems—or risk your reputation.
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.
FDA says it likely will oppose the provision because it would create more administrative complexity and increase fees paid by individual firms, but many provider and professional associations think waivers could help prevent and alleviate drug shortages.