Drug shortages have been increasing in frequency and significance in the last few years. The majority of shortages have involved injectable drugs, most commonly those used to treat cancer, infections, and nutritional deficiencies. These shortages present a significant public health issue, as shortages can delay or prevent patients from receiving necessary medications.

Drug shortages can occur for a variety of reasons. The primary reasons behind recent shortages in the U.S. include problems with the facilities that manufacture the drugs, delays in manufacturing or distribution, or shortages in necessary starting materials. Other reasons may be unanticipated increases in demand or manufacturers leaving the market due to business or economic reasons.

This issue has attracted a significant amount of media and government attention around the world. In October 2011, President Obama issued an Executive Order directing FDA to take additional action to address drug shortage issues. In November, UK legislators launched an inquiry into drug shortage issues in response to pharmacists’ complaints that they have been unable to dispense certain drugs due to supply issues.

In response to this growing problem, FDA has taken an increasingly larger role in addressing and preventing drug shortages. Specifically, FDA may ask other firms to increase production to compensate, work with manufacturers to address underlying quality issues, and/or facilitate faster review of regulatory submissions. Refer to the FDA webpage on drug shortages for more information.

While the causes of drug shortages are multifactorial, it is clear that drug manufacturers can spend significant time and resources addressing shortages and related quality issues. This highlights the need for drug manufacturers to take quality concerns seriously throughout development and production, engage in proactive quality audits of manufacturing facilities, and enact preventive measures to mitigate the risk of quality issues that may lead to shortages. Additionally, ongoing, open communication with FDA is vital to ensuring that these issues are addressed as efficiently as possible.

Posted by Lauren Wind, Senior Consultant. For more information, please contact Lauren at lauren.wind@weinberggroup.com.