By Lisa Seachrist

Washington Editor

WASHINGTON - If FDA Commissioner Jane Henney has her way, reviewers at the agency will have more opportunities to expand their scientific skills and will have more neutral, information-based interactions with industry scientists.

Henney outlined her plan to ensure decisions made at FDA are based on the "very best science" at the 2000 FDA Science Forum, titled "FDA and the Science of Safety: New Perspectives." Her plan is designed to ready the agency to meet the challenges encountered with new technologies.

"FDA's work force must be flexible and adaptable," Henney told her audience of regulators and members of industry. "The trouble with the future is it usually happens before we are ready for it."

In order keep abreast of changing science, Henney said all agency scientific reviewers should reserve at least 10 percent of their time to expand their skills and knowledge base. She noted, "This means we must have at least 110 percent staffing. This will not only require time but financial support as well."

In addition to making sure the scientific staff has the ability to conduct original research and attend important scientific meetings, Henney is taking a look at the scientific staff to make sure its expertise will match the demands of reviews coming in the future. She said the office of human resources has hired a contractor to help the agency determine "the configuration of the scientific work force, not just for the next year, but what it should look like five years from now."

Ensuring the agency has the most comprehensive in-house science base possible means recruiting and retaining the best scientists possible. Henney said, "Since my tenure of commissioner began, I've been repopulating the scientific work force with an eye to retaining quality scientists and establishing a consistent process of peer review for science at FDA."

In addition to a top-notch in-house staff, Henney noted the agency must sometimes go outside in order to apply the latest scientific thinking. While many of those contacts are of the informal variety, she maintained formal interactions with industry are vital to keeping up with science. Henney said the agency had recently sponsored a joint training session with FDA reviewers and Merck & Co. Inc. scientists on core barrier isolation technology, and other such interactions were in the works.

"It is in the interest of FDA to meet with industry on a neutral basis to explore the scientific milieu," Henney said. "We are looking at such interactions for drugs, devices and biotechnology."

"We do have a clear vision of our priorities," Henney said. "It is to our benefit to develop stronger linkages to NIH in order to be able to handle the new technologies. It is FDA's responsibility to maintain a science-based assessment of the risks associated with the products we regulate."

Henney noted the agency had challenges with food safety in preventing the spread of food-borne illness. In addition, she noted the agency had to face new challenges with biotech foods and ensuring the safety of these products.

In attempting to deal with the possibility of bioterrorism, Henney noted the Department of Defense, the Centers for Disease Control and Prevention and FDA would have to work together "to ensure adequate vaccine is stockpiled."

Henney noted the agency's agenda was "very full." While safety is the first goal of FDA, she noted safety doesn't mean the absence of risk. "Safety means the judicious weighing of the benefits and the risks," she said.