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28 Feb 2014

Rx-360 Summary of the First Annual Report on Drug Shortages

On 5 February 2014, the FDA provided their First Annual Report on Drug Shortages to Congress as required by Section 1002 of FDASIA. FDA believes that the increased notifications resulting from action by the Administration, Congress and FDA has allowed them to respond more effectively to shortages and potential shortages. Pages 1–5 summarize the legal authority in this area and the guidances and actions FDA has taken so far to prevent and mitigate drug shortages.  


FDA provides data on actions in this area, including but not limited to

• 39 different manufacturers notified FDA of 202 potential drug shortages.

• The Office of Generic Drugs (OGD) expedited review of 118 applications including 62 ANDAs and 56 supplements; the office of biological products expedited review of 7 supplements; in total CDER expedited review of 177 applications that includes ANDAs/NDAs and supplements in the first three quarters of calendar year 2013.

• 56 inspections were prioritized based on the applications/supplements that were granted expedited review.

• Figure 1 shows the number of new drug shortages annually between 2005 and Q1-3 of 2013. These increased to a high of 251 in 2011, decreased to 117 in 2012 and 38 for the first three quarters of 2013. They conclude that “…in the first three quarters of 2013, we have prevented 140 shortages.”

To view or download the Rx-360 Summary, click here

To view or download the FDA report, click here

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