FDA to Congress: agency not 'root cause' of drug shortages

FDA argued that it is not the "root cause" of drug shortages in a letter responding to a congressional report last month that claimed the shortages were "largely sparked" by agency actions.

The report, issued by the House Committee on Oversight and Government Reform, says that of the 219 drugs listed on the American Society of Health System Pharmacists shortage list as of Feb. 21, at least 128, or 58%, were manufactured by at least one facility undergoing FDA remediation. The report also notes that the number of total warning letters issued by FDA increased 42% from 2009 to 2010 and 156% from 2010 to 2011. ...