Washington Editor

WASHINGTON - Acting FDA Commissioner Lester Crawford in the late fall expects to release the national critical path opportunities list, which will pinpoint areas of product development that could benefit most from innovative approaches and emerging technologies.

The list is part of the agency's critical path initiative set up to create a new generation of performance standards and predictive tools for providing better and quicker results in the drug review process. (See BioWorld Today, March 19, 2004.)

First announced in March, the project is meant to help the FDA address some of the issues facing the biomedical industry. Understanding that drug and medical product development has become more costly, lengthier and more uncertain than ever before, the FDA wants to improve its processes to help companies get efficacious products to the market and into the hands of the public more quickly.

In his speech before the National Press Club in Washington recently, Crawford outlined the FDA's priorities for the next six months, indicating that the chore topping the list is the agency's review of public comments related to the critical path initiative and insights on hurdles to therapeutic product development.

Beyond that initiative, Department of Health and Human Services (DHHS) Secretary Tommy Thompson named Crawford chairman of a task force on medical technology innovation created to look for opportunities throughout DHHS to streamline and promote faster access to new medical technologies. (The FDA is part of DHHS.)

In his position as chair, Crawford will host a series of public meetings throughout September, and is expected to forward a set of recommendations to Thompson by the end of the year.

Also among the priorities, Crawford plans to help increase patient access to drugs by continuing to make the generic drug program a priority.

The FDA is moving ahead on a new proposed rule for expanding the use of investigational drugs for patients facing serious and life-threatening diseases, and plans to expedite global access to treatments for HIV/AIDS.

On HIV and AIDS, in recent months the agency has issued guidance and is providing technical assistance to help ensure that the U.S. is providing safe, effective drugs to developing countries under the president's Emergency Plan for AIDS Relief.

In the area of patient and consumer protection and education, Crawford said over the next few months the FDA would finalize its proposed changes to prescription-drug labeling to make the label more user-friendly for patients and health care practitioners.

To view the entire list of priorities, several of which deal in food manufacturing and obesity, visit the agency's website at www.fda.gov.

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