The FDA, Government Accountability Office (GAO), Congress, academia, and others, have thoroughly examined the issue of drug shortages and identified manufacturing problems, quality control issues, and barriers to getting new suppliers online as the primary causes of shortages. Here is what others are saying about drug shortages:
“Two factors [that contribute to drug shortages]—a decline in the number of suppliers and failure of at least one establishment making a drug to comply with manufacturing standards resulting in a warning letter—suggest that shortages may be triggered by supply disruptions.” U.S. Government Accountability Office, Drug Shortages: Certain Factors Are Strongly Associated with This Persistent Public Health Challenge (2016)
“The immediate cause of drug shortages can generally be traced to a manufacturer halting or slowing production to address quality problems.” U.S. Government Accountability Office, Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability (2014)
“There are a number of factors that can cause or contribute to drug shortages that are outside of the FDA’s control. Sometimes manufacturers have an unforeseen breakdown in manufacturing line that affects their production. Other times, shortages are caused by longstanding quality manufacturing issues.” FDA Drug Shortages Infographic
“There have been other reasons [for drug shortages] such as production delays at the manufacturer and delays companies have experienced receiving raw materials and components from suppliers.” FDA FAQ on Drug Shortages
“The majority of drug shortages, an estimated 70%, are the result of a breakdown in quality and manufacturing.”
Dr. Margaret Hamburg, Former FDA Commissioner
“GPOs are currently working collaboratively with manufacturers, distributors, the FDA and the Department of Health and Human Services to ensure that hospitals and patients have access to the life-saving drugs they need. They are also taking a variety of innovative steps to mitigate the impact of drug shortages.”
Former Members of Congress Phil English, Byron Dorgan, and Robert Bennett
“Phil Zweig and Physicians Against Drug Shortages saying that GPOs are the primary contributor to such market distortions is like the mall industry calling out bad weather as the cause for spikes in shoplifting. It’s like blaming Obamacare for Detroit going broke. It’s what statisticians refer to as a logical fallacy.”
Tom Finn, Healthcare Matter
For more information on GPO efforts to help combat critical prescription drug shortages, please visit www.drugshortage.org
For additional drug shortage resources, click here.
For more information on Physicians Against Drug Shortages or its Executive Director Phil Zweig, click here.