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Statement from FDA Commissioner Margaret Hamburg, M.D. and Assistant Secretary for Health Howard Koh, M.D., M.P.H. on Drug Shortages

September 9, 2011

Today, the U.S. Department of Health and Human Services convened a meeting of stakeholders to discuss and explore solutions to the drug shortages affecting patients in the United States. These shortages include cancer drugs, anesthesia drugs, and other critical medications in the U.S.

There is no quick solution that solves this critical public health issue; addressing it will require a multifaceted approach. FDA plays a unique role in responding to and helping to prevent drug shortages. Today's meeting was a constructive step in the right direction.

All parties involved in the supply of drugs to Americans have a responsibility to make sure patients have access to the drugs they need. There are many factors that contribute to drug shortages, and FDA will soon release a report which reflects an important analysis of the problem and recommendations with respect to its role. Promising solutions are also being rigorously examined. One suggestion is a mechanism for manufacturers to report impending supply disruptions and discontinuation of drugs, which could help to curb drug shortages and improve the continuity of the drug supply. The sooner the FDA learns of a drug shortage, the more effective it can be in helping to notify providers and minimizing the impact on patients.

Meanwhile, the FDA will continue its efforts to work with manufacturers to ameliorate shortages. For example, FDA already expedites requests to qualify new manufacturing sites, new production lines or new raw material suppliers to avert drug shortages. HHS remains committed to working with manufacturers, providers, patient advocates, and other stakeholders to help minimize drug shortages, protect patients, and identify solutions to this serious problem.

We look forward to continuing the dialogue at FDA's public meeting on September 26th.