The View From Here

Janet Woodcock, M.D.

The Critical Path Initiative: Where We’re Headed

The U.S. Food and Drug Administration unveiled the Critical Path Initiative with the intent of using scientific advances, such as genomics and advanced imaging technologies, to modernize drug development.

Published in March 2004, the first Critical Path paper was a wake-up call to stakeholders. It cautioned that the FDA’s ability to evaluate and predict product performance would continue to be limited and that the path-to-product approval likely would be difficult and problematic without a substantial investment in development (regulatory) science.

FDA product reviewers and scientists have done their best to keep up with expectations of product safety and efficacy in a time of vigorous drug and medical product development. But resources are limited.  The Critical Path Initiative was conceived as a way to bridge the gap between basic scientific research and the medical product development process.

Since the first paper, we have expanded our vision of the Critical Path Initiative to include veterinary medicines, generic drugs and foods. For all product areas, the idea is to use scientific research to reduce uncertainty about the performance of a regulated product throughout the product life-cycle.  We have set up a number of collaborations to get this research done in areas ranging from drug manufacturing to clinical trial design.

Projects already underway include work with the Juvenile Diabetes Research Foundation on standards for an artificial pancreas, collaboration with Duke University on drug eluting stents, and safety biomarker research with the C-Path Institute’s Predict Safety Testing Consortium.
The reviews presented in this issue of E-Choice provide a sampling of the many collaborative activities at the FDA. They also provide a glimpse of a not-too-distant future when a spirit of cooperation augmented by a new generation of tools – assays, biomarkers, better clinical trial designs, improved animal models, and others – will result in a more efficient medical product pathway with improved safety and efficacy.

Enjoy the read!

Janet Woodcock, M.D.
FDA Deputy Commissioner, Chief Medical Officer and Acting Director
Center for Drug Evaluation and Research

Dr Woodcock is a Deputy Commissioner and the Chief Medical Officer of the FDA. She oversees scientific and medical regulatory operations for Agency. Most recently, Dr. Woodcock served as the Deputy Commissioner for Operations and Chief Operating Officer, FDA 2005–2007.   She also served as Director of the FDA’s Center for Drug Evaluation and Research 1994–2005.  Dr Woodcock received her M.D. from Northwestern Medical School, and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco.  She joined FDA in 1986.