FDA's role in responding to drug shortages.

The Drug Shortage Program at the Food and Drug Administration (FDA) is a division of the Center for Drug Evaluation and Research (CDER), one of the five centers within FDA. The four other centers include the Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine. At the Drug Shortage Program, we strive to ensure that safe and effective prescription, over-thecounter, and generic drugs are available to the American public. Other products, such as vaccines, biologicals, veterinary drugs, devices, radiological products, and nutraceuticals, fall into the jurisdiction of the other four centers. The Drug Shortage Program was developed to respond to drug shortages that have a significant impact on public health. Our program has expanded in the past two years because of the increasing number and complexity of drug shortages. In addition to two full-time project managers, individuals from the Office of Generic Drugs, the Office of Compliance, and CDER Drug Information share the responsibilities involving drug shortages. A coordinated effort is often required between manufacturers and various components within FDA to deal with a drug shortage. The purpose of this article is to discuss FDA’s role in resolving drug shortages.