This inaugural report to Congress (PDF-200KB) summarizes the major actions FDA has taken to prevent or mitigate drug shortages in the United States from Jan. 1, to Sept. 30, 2013, and information about shortages that occurred. This report is required under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA).
Preventing and mitigating drug shortages (PDF-380KB) continues to be a top priority for FDA. Drug shortages can have serious and immediate effects on patients and health care professionals.
We work with a wide range of stakeholders to prevent and mitigate drug shortages. Early notification of potential shortages gives FDA additional time to work with manufacturers and other groups to identify ways to maintain treatment options and prevent a shortage. FDA is also working to promote and sustain manufacturing quality in an effort to prevent or mitigate drug shortages.
FDA will continue using every available tool to ensure patients have access to the medications they need.