Keeping you updated on the latest Medicare and Part D news

FDA Unveils Plan to Address Prescription Drug Shortages

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Last week the FDA released several initiatives to prevent and address prescription drug shortages through improved notification and communication channels. Between 2010 and 2012, there were 546 shortages in the US, most of which the FDA attributes to quality and manufacturing issues, as well as a lack of inputs from suppliers. In 2010, shortages reached an all-time high, leading President Obama to issue an Executive Order in 2011 to address the issue. The new FDA measures include expanding early reporting requirements for manufacturers, launching a smartphone app to give consumers real time information on prescription drug shortages, and clarifying emergency roles and responsibilities for manufacturers.



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