Rx-360 Summary of the GAO Drug Shortage Report

In 2012, FDASIA provided FDA with additional authority to address drugs shortage and also required GAO to study the drug shortage situation. The GAO recently published a report: DRUG SHORTAGES, Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability. In this report GAO evaluates the high level causes of drug shortages and their impact on public health, evaluates the effectiveness of actions that FDA has taken to prevent and mitigate the impact of drug shortages, and makes recommendations for FDA to enhance its oversight of drug shortages. 
 

The GAO report also reviews economic causes of drug shortages, particularly for generic sterile parenteral products.  GAO acknowledges the progress that FDA has made in preventing shortages and mitigating their impact and suggests that FDA use their data to “…proactively identify drug shortage risk factors.”

To view or download the GAO Report, click here

To view or download the Rx-360 Summary of the GAO Report, click here