New FDA recommendations to speed drug development

On 12 January 2006, the US Food and Drug Administration (FDA) released guidance documents to help scientists speed the development of new medical treatments in clinical research, in an effort to accelerate the process by which new drugs are brought to market for potentially serious and life-threatening diseases of human patients^1,2,3.

In the first document, the FDA advises scientists who plan to conduct very early clinical studies in people on how to perform appropriate safety tests and produce small amounts of drugs safely, flexibly, and efficiently⁴. The second document provides guidance on how to comply with current good manufacturing practice (CGMP) requirements for drugs undergoing early (Phase 1) safety studies⁵.

Health and Human Services Secretary Mike Leavitt stated that “Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies.” The new FDA recommendations, he said, “will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs¹.”

According to Janet Woodcock, MD, FDA Deputy Commissioner for Operations, these new guidances will help researchers who conduct small studies to overcome the burdensome requirements for early Phase 1 studies, which previously required such investigators to implement the same procedures as manufacturers who produce and distribute large amounts of medicines¹