New GAO Report Says FDA Needs More Power to Address Drug Shortages

What GAO Found

In brief, we found that the number of drug shortages has grown substantially in recent years, and FDA is constrained in its ability to protect the public health from the impact of these shortages. (1) The number of drug shortages has grown substantially since 2006, and many shortages involved generic injectable drugs. In total, 1,190 shortages were reported from January 1, 2001, through June 20, 2011, according to UUDIS data. From 2006 through 2010, the number of drug shortages increased each year and grew by more than 200 percent over this period. A record number of shortages (196) were reported in 2010, and 2011 is on pace to surpass 2010’s record, with 146 shortages reported through June 20, 2011. (2) The drug shortages we reviewed in detail were generally caused by manufacturing problems and exacerbated by multiple difficulties. Twelve of the 15 drug shortages we reviewed in detail were primarily caused by manufacturing problems, including those that resulted in manufacturing shutdowns, according to information provided by FDA and by manufacturers. (3) FDA responds to known drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA officials explained that they respond to all of the shortages of which the agency becomes aware, and they determine how to address each shortage based on its cause and the public health risk associated with the shortage. (4) FDA is constrained in its ability to protect public health from drug shortages. Specifically, FDA is constrained by its lack of authority to require manufacturers to provide the agency and the public with information about shortages, or require that manufacturers take certain actions to prevent, alleviate, or resolve shortages.