Public Health Preparedness: Medical Countermeasure Development for Certain Serious or Life-Threatening Conditions

Past bioterrorist attacks, such as the anthrax attacks of 2001, highlight the threats posed by chemical, biological, radiological, and nuclear agents—and the importance of medical countermeasures to treat people in the aftermath.

FDA established the Animal Rule in 2002 to allow for the approval of medical countermeasures based on animal studies when human clinical trials are not ethical or feasible.

We found that FDA has provided guidance to support development of medical countermeasures under the rule, such as by clarifying the types of data needed to demonstrate product efficacy.

FDA has approved 16 medical countermeasures under this rule.

FDA Human Clinical Trials

What GAO Found

The Department of Health and Human...