Washington Editor

WASHINGTON - The FDA will stay the course set by former Commissioner Mark McClellan and Health and Human Services Secretary Tommy Thompson, acting FDA Commissioner Lester Crawford said here Thursday.

Crawford, a veterinarian who temporarily headed the agency before McClellan came on board in late 2002, is back at the helm as McClellan has accepted the leadership role at the Centers for Medicare and Medicaid Services (CMS).

Nevertheless, both officials served as keynote speakers at the Food and Drug Law Institute's 47th annual Science, Regulation, Business and Law Conference, this year themed "Transforming Challenges Into Opportunities." As expected, McClellan spent the bulk of his time discussing positive aspects of the new Medicare law, which he will be in charge of implementing as CMS administrator.

But the FDA isn't a distant memory for McClellan, who spent about 30 minutes warming up the audience of about 650 by addressing topics like the slowdown in new medical products reaching patients despite growing research and development investments and the tremendous progress in the basic biomedical sciences.

Around Washington, people say it costs roughly $800 million to bring a drug to market (figure includes failures), but Thursday, McClellan said he hears the figure actually is hitting $1 billion.

McClellan and Crawford said the FDA does not want to be part of the bottleneck that costs drug companies more money via delays caused by poor or limited communication between the industry and government.

Before leaving the FDA, McClellan, Crawford and Janet Woodcock, the agency's acting deputy commissioner for operations, set up a task force charged with creating a new generation of performance standards and predictive tools aimed at providing better and quicker results regarding the safety and effectiveness of investigational products. The project is referred to as the critical path initiative. (See BioWorld Today, March 19, 2004.)

"Making the critical path [of drug development] less costly and more predictable has long been a goal of the FDA," said McClellan, who encouraged attendees to visit the agency's website to review the task force's white paper on the subject.

"We are hopeful that as we come together to improve the critical path, we can see more technologies developed in the lab become breakthrough products on the market," McClellan said.

The fact that technology is not rapidly transforming into medicine was apparent back in 2000, the year that scientists were celebrating the mapping of the human genome, he said. "That year, the number of [drug] applications at the FDA were at an all-time low," McClellan said.

While application traffic has increased since, Crawford said it is too early to tell whether it's a trend toward the positive.

Whatever the case, FDA officials have vowed to fix the problem on their end.

As for the critical path proposals, Crawford said each year the agency expects to have new guidance on different diseases or indications.

For example, he said, if an obesity drug were the subject of a critical path, the FDA would provide descriptive guidance about what is expected in the clinical and regulatory process from concept to bedside. Also, he said, under the initiative, the FDA would begin to better provide scientists, investors and companies with information on the types of diseases needing new treatments and on research grants available through the National Institutes of Health.

The initiative also calls for the FDA to work with the industry, academia and other government agencies to develop the "Critical Path Opportunities List," designed to identify areas that would benefit the most from a modernized path of medical product testing and manufacture.

Crawford said the critical path initiative would be discussed in greater detail at the agency's annual science forum scheduled May 18-19 in Washington.