FDAnews Drug Daily Bulletin


March 20, 2006

The FDA has unveiled its long-awaited Critical Path Opportunities List, focusing on projects that will advance the use of biomarkers and streamline clinical trials.

The agency is planning an extensive review of 76 potential projects, with an eye toward whittling down the list over the next few weeks to a few plans the FDA will implement. The FDA is focusing on six key areas for Critical Path: better evaluation tools, biomarkers and disease models, streamlining clinical trials, harnessing bioinformatics, improving manufacturing processes, products that address urgent public health needs and at-risk populations.

Based on its outreach efforts, the agency has determined that the two most important areas for improving medical product development are biomarker development and streamlining clinical trials.

Most researchers agree that a new generation of predictive biomarkers would dramatically improve the efficiency of product development, help identify safety problems before a product is on the market (and even before it is tested in humans), and facilitate the development of new types of clinical trials that will produce better data faster, said Janet Woodcock, the FDA's deputy commissioner for operations and head of the Critical Path Initiative. "Similarly, researchers stressed that reforming the clinical trial process -- both trial design and trial conduct -- would dramatically improve the efficiency of product development, which means getting products to patients faster at less cost," she said.

One factor the agency will consider in choosing projects is whether it has sufficient funding for Critical Path. The FDA will begin in April to consider its ability to use agency funding to support selected Critical Path projects.

The agency has asked for $5.9 million in the fiscal year 2007 budget to help fund the program, Woodcock said.

The possibility that acting FDA Commissioner Andrew von Eschenbach may be confirmed as the permanent head of the agency will bolster the FDA's push for full funding of Critical Path, industry sources said. But the agency's delay in making a decision on the controversial Plan B contraceptive could slow his confirmation, sources say. Woodcock declined to comment on whether the agency would accelerate the Plan B review to help ensure that von Eschenbach is confirmed.

Meanwhile, the agency plans to work cooperatively with other government agencies and private entities to implement the Critical Path plans, which should help fund these programs, agency officials said. "The Critical Path is all about collaboration," said Woodcock. Critical Path is "a shining example of how we can share resources."

Cooperation was the watchword for the agency during the unveiling of the list of key areas. The FDA believes that greater cooperation among the public and private sector is essential to improve the drug development pipeline, which is the essential goal of Critical Path.