ASCO remains alarmed about the high number of drug shortages and supports strengthening the FDA’s current capacity to monitor the adequacy of the nation’s drug supply.
—Richard L. Schilsky, MD, FACP, FASCO
“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 by improving its responsiveness to emergent supply chain disruptions in the past 2 years. However, the GAO report determines that current FDA efforts to prevent and resolve shortages suffer from lapses in data availability and quality that prevent FDA from improving its response to drug shortages. These shortcomings hinder the FDA’s ability to understand the causes of specific shortages and proactively develop strategies to prevent them from occurring.
“ASCO remains alarmed about the high number of drug shortages, particularly of sterile injectable chemotherapy and supportive care products, and supports 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.” ■
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...