Manufacturing problems and shortages of cancer drugs

The Government Accountability Office (GAO) has released its report on the state of shortages for cancer drugs and other conditions and has highlighted manufacturing problems as a major cause.

Following current news reports on the shortages of many drugs used for cancer and other conditions, the Senate Committee on Health, Education, Labor and Pensions asked the GAO to examine the reason for the shortages, including the Food and Drug Administration’s response to the growing problem.

Key findings from the report cite problems with factories, as well as access to drug ingredients, are a major cause of the shortages. Often, drugs are made by a handful of manufacturers, and if production is interrupted for one of the companies, it can be difficult for the others to quickly increase production to make up the difference.

A lack of stringent guidelines and requirements for reporting to the FDA accounts for many manufacturers not informing the Administration of the shortages. The GAO noted that, currently, the FDA must rely on voluntary reporting by physicians, hospitals and even patients for much of their information about drug availability.

The GAO concluded that the number of drug shortages has substantially increased in recent years, including those for life-saving medications like oncology drugs—a situation that has jeopardized the public health. While the FDA may not always be able to prevent shortages from occurring, the agency’s response is often constrained by its lack of authority in requiring manufacturers to report shortages.

The report recommends that Congress consider requiring drug manufacturers to document any changes that could affect the drug supply, and to increase resources for the FDA Drug Shortage Program, including an improved information system for data tracking. According to the report, with advanced warning the FDA has demonstrated it can prevent a majority of such shortages from occurring.