The U.S. Government Accountability Office (GAO) recently issued a report evaluating drug shortages and the associated public health threats, including prolonged duration of a disease, permanent injury, and death.1 This report follows a recommendation by GAO in 2011 that the U.S. Food and Drug Administration (FDA) enhance its ability to respond to shortages.
In the recently released report, GAO has reviewed trends in drug shortages, effects on patients and providers, causes, and FDA progress in addressing shortages. GAO has recommended that FDA strengthen its internal controls over its drug shortage data, and that the Agency conduct periodic analyses to routinely and systematically assess drug shortage information to proactively identify drug shortage risk factors.
According to the GAO report, there is a high number of drug shortages, and although new drug shortages declined in 2012, the total number of shortages active during a given year has increased since 2007. This includes both new shortages reported and ongoing shortages that began in a prior year.
Many shortages are of generic sterile injectable drugs and result from a manufacturer halting or slowing production to address quality problems, triggering a supply disruption. In other cases, manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity. Quality and economic issues also were reported to be factors causing drug shortages.
The report noted that although shortages have persisted, FDA has prevented more potential shortages in the last 2 years by improving its responsiveness and implementing recommendations made by GAO in 2011. FDA has also developed procedures to enhance coordination between headquarters and field staff. However, according to the GAO report, shortcomings in its management of drug shortage data are inconsistent with internal control standards.
For example, FDA has not created policies or procedures governing the management of the data and does not perform routine quality checks on its data. In addition, FDA has not conducted routine analyses of the data to proactively identify and evaluate the risks of drug shortages.
In response to the GAO report, ASCO has issued a statement in support of strengthening the FDA’s current capacity to monitor the adequacy of the nation’s drug supply for the benefit of people with cancer and other conditions (see sidebar on page 15). ■
1. U.S. Government Accountability Office: Drug shortages: Public health threat continues, despite efforts to help ensure product availability. Report GAO-14-194, published February 10, 2014. Available at www.gao.gov/products/GAO-14-194. Accessed February 11, 2014.
“The GAO report identifies production lapses due to quality problems and constrained manufacturing capacity as being the central causes of the widespread incidence and persistence of drug shortages.
“The report also emphasizes that the FDA has made significant progress in preventing shortages...