Drug Shortages Exacerbated by Supply Chain Woes
FDA Drug Shortage Report
In July 2012, the Food and Drug Administration Safety and Innovation Act became law. In addition to requiring drug manufacturers to provide timely notice of impending or unexpected medication shortages, FDASIA required the FDA to issue annual reports on pharmaceutical shortfalls.
The federal agency released its first "Annual Report on Drug Shortages" this month, with the research focusing on the first three months of 2013. The report notes a slowing in the rate of new medication shortages.
"While the number of new shortages… quadrupled from approximately 61 shortages in 2005 to more than 250 in 2011, after actions by the FDA working with stakeholders, that number significantly decreased in 2012 to 117 shortages. However, shortages continue to pose a real challenge to public health," the report states.
The FDA report indicates reforms in recent years such as FDASIA are having an impact.
"As a result of recent actions by the President, Congress, and FDA, manufacturers are notifying FDA about potential shortages earlier than in the past. Early notification of potential shortages gives FDA additional time to work with sponsors and other groups to identify ways to maintain treatment options and prevent a shortage," the report states.
"Using a range of available tools, including regulatory flexibility when appropriate, FDA's Center for Drug Evaluation and Research (CDER) worked with manufacturers to successfully prevent 140 shortages from January 1 to September 30, 2013. In addition, the number of new shortages tracked by CDER for this same time period is 38, compared to the 117 new shortages during calendar year 2012."
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