FDA's Ability to Respond Should Be Strengthened
GAO-12-315T: Published: Dec 15, 2011. Publicly Released: Dec 15, 2011.
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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 2010s 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.
Why GAO Did This Study
The testimony discusses the Food and Drug Administrations (FDA) response to prescription drug shortages. According to FDA, a record number of drugs were in short supply in 2010, and the number of drug shortages has continued to grow throughout 2011. A variety of factors can trigger drug shortages, such as disruptions in the supply of the active pharmaceutical ingredients required to manufacture the drug, manufacturing problems, manufacturers business decisions, and increased demand for products. Drug shortages directly threaten public health by preventing patients from accessing medications that are essential to their care. During shortages, physicians may have to ration their supplies, delay treatments, or use alternative medications that may be less effective for the condition, carry unwanted side effects, or cost more. Consistent with its mission of protecting the public health, FDA, an agency within the Department of Health and Human Services (HHS), established a Drug Shortage Program to help prevent, alleviate, and resolve shortages.
Drug shortages may be reported to FDA by manufacturers, health professionals, or the public. FDA also obtains information from the American Society of Health-System Pharmacists (ASHP), which tracks and makes information publicly available about nationwide drug shortages through a partnership with the University of Utah Drug Information Service (UUDIS).
This statement will highlight key findings from our November 2011 report, which is being released today, that reviews trends in prescription drug shortages and FDAs response. In that report, we (1) reviewed trends in prescription drug shortages that occurred from January 2001 through June 2011, (2) identified the reported causes of selected drug shortages that occurred from January 2009 through June 2011, (3) described FDAs response to drug shortages, and (4) evaluated the extent to which FDA is able to protect the public health through its response to drug shortages.