President Obama on Monday signed into law the Food and Drug Administration Safety and Innovation Act, including provisions to help alleviate drug shortages, according an AHA News Now report.
The bipartisan-backed bill requires drug makers to report production interruptions and discontinuations to the FDA in advance. The new law also gives the FDA authority to speed approval of applications for drugs in short supply and lifts certain caps on narcotic ingredients to ensure sufficient supply for pain management, anesthesia and other uses.
Additionally, the legislation creates a user fee program for generic drugs, intended to jumpstart FDA approval of generics. It also allows hospitals within health systems to share repackaged drugs when they are in short supply.
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The bipartisan-backed bill requires drug makers to report production interruptions and discontinuations to the FDA in advance. The new law also gives the FDA authority to speed approval of applications for drugs in short supply and lifts certain caps on narcotic ingredients to ensure sufficient supply for pain management, anesthesia and other uses.
Additionally, the legislation creates a user fee program for generic drugs, intended to jumpstart FDA approval of generics. It also allows hospitals within health systems to share repackaged drugs when they are in short supply.
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