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US Food and Drug Administration’s (FDA) Prescription Drug User Fee Reauthorization Act 

04-19-2012 17:49

The Senate Health, Education, Labor and Pensions (HELP) Committee led by Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) introduced the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Reauthorization Act, which includes a section on preventing and mitigating drug shortages (click here to access the legislation. The drug shortages provision would require manufacturers to notify the FDA at least 6 months in advance of discounting or interrupting the manufacturing of a drug. The provision also requires distribution of information to stakeholders in the physician community so they can plan and adjust care accordingly.

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