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Mar 22, 2004
 |  BioCentury  |  Politics, Policy & Law

FDA's path less traveled

FDA has launched a "critical path" initiative that is intended to identify ways to use its expertise - and its access to proprietary information - to help make the drug development process shorter, better and cheaper. Specifically, the agency wants to enable sponsors to design more informative clinical trials, to minimize late-stage failures, to better predict potential safety issues, and to manufacture products more efficiently.

According to FDA, critical path research focuses on the stages from "selection of a laboratory prototype to delivery of an effective treatment to patients."

The agency released a report last week explaining the concept, providing examples of work the agency has performed that has removed obstacles to product development, and soliciting collaboration in identifying a list of critical path opportunities.

The agency says the critical path has been little traveled because it falls outside traditional areas of federal funding and is beyond the scope of most product-focused industry research. In addition, to work best it would require the pooling of data from a wide variety of in vitro, preclinical and clinical experiments, much of which is proprietary and inaccessible to individual companies.

Little federally funded research is directed at the kinds of nuts and bolts issues that would speed drug development. Congress has allocated about $27 billion to NIH for fiscal 2004, mostly for basic biomedical research. FDA's research budget, intended to support its regulatory work and a handful of applied areas such as bioterrorism countermeasures and orphan products, was about $1.5 million - less than the rounding error on the budgets of any of NIH's 20 centers.

The disparity in federal funding for basic and applied biomedical research would make sense if the biopharmaceutical industry's investment in R&D meshed well with NIH's work. The declining number of applications to market new...

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