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Three years ago, when we launched the Critical Path Initiative, it was conceived
as a way to bridge the gap between basic scientific research and the medical
product development process. The public and private sectors have made
massive investments in basic biomedical research over the past three decades.
At the same time, investment in development science, or what we call “regulatory
science,” needed to predict and evaluate product performance, has lagged
significantly. FDA researchers and reviewers tried to bridge this gap,
but resources were lacking, and we were never fully successful in explaining
the crucial importance of independent research into product characterization
and manufacturing, analytical and other test methods, animal models, toxicology,
biostatistics, clinical trial design, and other subjects that are crucial to
developing safe and effective products. And with the emerging application
of genomics, proteomics and other molecular technologies, advanced imaging
techniques, nanotechnology, robotics, etc. to medical uses, the gap was growing
wider.
The first Critical Path paper, published in March 2004, was intended as a wake-up call to all stakeholders: that without significant investment in development science, our ability to evaluate and predict product performance would continue to be quite limited, and the path to market and beyond, fraught with problems. We called for a collaborative cross-sector effort to modernize development by performing the research needed to incorporate new genomic, imaging, statistical, methodologic, analytical and informatics tools into the development and review processes and standards.
Since the initial report, we have broadened our thinking about the Critical Path Initiative to include veterinary medicines, generic drugs, and even foods. For all product areas, the basic idea is to reduce uncertainty about product performance throughout the product life cycle through scientific research. We have set up a large number of collaborations with partners to get this research done, in areas as disparate as drug manufacturing and clinical trial design.
Last year, after extensive FDA and public input, we published a list of 76 examples of promising and high-priority projects that we hoped this initiative would foster. (The report is available online at http://www.fda.gov/oc/initiatives/criticalpath/.) A number of these projects have started. Examples include work with the Juvenile Diabetes Research Foundation on standards for an artificial pancreas; a collaboration with Duke University on drug eluting stents; and safety biomarker research with the C-Path Institute’s Predictive Safety Testing Consortium. In all cases, we look to FDA reviewers and scientists to identify the most pressing problems and scientific issues, so that we can recruit partners to help us address them. In many areas, we are building on work that has already been started.
Thanks to the efforts of many within FDA – and our partners in academia, the non-profit sector, and industry – the Critical Path initiative is off to a very good start. What is perhaps the most remarkable aspect of this initiative is that our progress to date has been achieved by drawing on existing financial resources, collaborative relationships, and the considerable efforts of many dedicated FDA employees. I hope that our efforts will continue to receive support, because the Critical Path truly holds the potential to usher in a new era of certainty and predictability in the development and performance of products that we regulate. The ultimate beneficiaries of our efforts will be the public that we serve.
Janet Woodcock, M.D.