FDA Releases Strategic Plan to Address Drug Shortages

November 21, 2013
by Dimitrios Tsipanitis

In October the Food and Drug Administration (FDA) released a strategic plan to prevent and resolve drug shortages.  Drug shortages are a major public health issue in the United States, denying the much needed treatment of certain drugs to patients.  When there is a shortage of a needed drug, physicians must prescribe therapies that might be less effective or even a long shot.  The drug shortages are occurring for many reasons including natural disasters, profitability, and other reasons but everyone can agree that it’s important to stop these drug shortages from occurring.

This strategic plan was called for as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.  The FDA does not control drug manufacture production, or have the authority to force any drug company to make a certain drug.  However with the strategic plan, the FDA will work to improve communications with drug manufacturers.  For example if a certain drug manufacturer knows that there will be a shortage they will contact the FDA ahead of time.  That way the FDA can work to prevent and resolve the shortage.  This could happen by the FDA reaching out to other manufacturers to increase production or providing funds to the manufacturers if needed to complete their work.  The main goal of the strategic plan is to improve communication between the FDA and drug manufacturers to resolve the drug shortage issue and make sure patients get the drugs they need.

Figure 5. FDA’s Key Supply Chain Information Sources
FDA report graphic
Food and Drug Administration, (2013). Strategic plan for preventing and mitigating drug shortages. Retrieved from website: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf

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