GAO Study Finds FDA Actions Have Reduced New Drug Shortages, Recommends Additional Action

Steps taken by FDA have successfully reduced the number of new drug shortages, and a new study from the Government Accountability Office (GAO) urges the agency to take additional steps to reduce the number of overall drug shortages. The report acknowledges the impact of recent FDA actions, including implementation of FDA Safety and Innovation Act regulations and requirements previously recommended by GAO in 2011.

The number of new drug shortages declined from 255 in 2011 to 195 in 2012. However, the total number of ongoing shortages, defined as shortages that began in previous years, has increased each year from 2007 to 2012. In order to enhance its ability to respond to shortages, GAO advised FDA to strengthen its internal controls for the agency’s drug shortage data so that that such data can be analyzed and used to proactively identify drug shortage risk factors. The Department of Health and Human Services agreed with the recommendation.

The study was based on analyses of FDA and the University of Utah Drug Information Service data. The GOA interviewed officials from FDA, other federal agencies, organizations representing health care providers and patients, and drug manufacturers. In addition to reviewing FDA’s progress in addressing drug shortages, the report also reviews the trends in recent drug shortages and describes what is known about their effect on patients and providers and examines the causes of drug shortages.