Practical Insights for Drug Development Using the Animal Rule

Abstract

The Food and Drug Administration’s (FDAs) Medical Countermeasures Initiative was launched in 2010. The initiative is intended to coordinate health care responses to potential chemical, biological, radiological, nuclear, and emerging infectious disease threats by ensuring that the medical countermeasures (eg, drugs, vaccines, and diagnostic tests) that are developed are safe, effective, and secure. The incentives for developing these medical counter-measures include the potential to secure a Priority Review Voucher under the 21st Century Cures Act and the potential for an extended 5 years of exclusivity for the chemical entity. These incentives have increased interest in medical countermeasures and in the use of the Animal Rule to demonstrate substantial evidence of efficacy. This Mini Review offers practical insights into the purpose, challenges, and benefits of using of the Animal Rule as the regulatory route for new drug approval. The information presented is derived from the FDAs Guidance document [1].