Washington Editor

WASHINGTON - The challenges faced today by the FDA commissioner are unlike any his predecessors confronted in previous years, the agency's top chief said Friday.

"The simple truth as I see it today is that the FDA of the 20th century is not adequate to regulate the reality of the food and drugs of the 21st century," FDA Commissioner Andrew von Eschenbach said during a speech at the National Press Club.

The agency, which is responsible for regulating products that account for one-fifth of the nation's consumer spending, needs to be "recreated" to keep pace with the "radical and rapid changes" of the 21st century, he asserted.

"This is a time in which the wind of change in health care in terms of power and pace is not a gentle breeze, but a jet stream," von Eschenbach said. "We are now creating medicines that don't just treat the manifestation of disease but actually alter the biology of the living cell. The FDA must respond to these changes if it is to continue to fulfill its mission of protecting and promoting your health. Today the peril is great, but the promise is unlimited."

In a global economy, where foods are imported from around the world and the ingredients of drugs are produced in many foreign nations under a complex manufacturing supply chain, the "FDA can no longer simply be a gatekeeper assessing the benefit and risk of products that are brought before us before they will be allowed to be delivered to patients and the public," von Eschenbach said, noting the complexities involved in the agency's investigation of the blood-thinning agent heparin, for which there have been recent reports of four deaths and hundreds of allergic-type reactions tied to the drug.

The active pharmaceutical ingredients for Baxter International Inc.'s heparin are made in China, but the raw materials in those ingredients are first obtained through a complex system that involves pig farms and slaughter houses.

"We will no longer be able to simply rely on inspections to verify quality," von Eschenbach declared. "We must and are engaging in the philosophy of the total life cycle of the products we must regulate, whether it is food going from farm to fork or whether it is medical products going from production to consumption. Engaging the FDA in each stage of discovery, development and delivery of the products we regulate will enable us to better assure their quality."

As the FDA's responsibilities continue to grow, he said, the agency's funding must keep pace to ensure the agency can fulfill its duties.

"We are on a trajectory of increases," von Eschenbach said, which "must continue and, as justified, must accelerate."

Congress also must pass legislation to ensure the FDA has the authority it needs to continue to fulfill its regulatory mission, he said, calling on lawmakers to pass pending legislation by Memorial Day that affects the way the agency regulates and protects the nation's food supply.

Industry needs to be responsible, and the public needs to have trust and patience in the agency, von Eschenbach added.

"We can't transform this agency ourselves," he said.

Some of the actions the agency currently is undertaking to respond to the rapid and radical changes of the 21st century, von Eschenbach said, is an assessment of its work force.

"That assessment has demonstrated a critical need to expand the numbers and skill sets required for our regulatory mission," he said. "We've embarked on an aggressive recruitment effort targeting an additional 700 new individuals to FDA in 2008."

That recruitment process, he said, has been made responsible by the "incremental increases" in funding the agency will receive under the Food and Drug Administration Amendments Act of 2007.

The agency also plans to soon launch a fellowship program "that has the potential to attract up to 2,000 individuals for two-year training program at the FDA," von Eschenbach said, which is intended to bolster its work force.

The FDA also intends to renovate and modernize its information technology systems in the coming year, he noted.

"This year we will spend approximately $250 million to employ modern, high-performance servers and new software systems that will facilitate our interoperability across the agency and expansion of our electronic database."

Changes in programs and processes, von Eschenbach said, need to be accompanied by changes in policies.

"The realities of the radically and rapidly changing world require new ways of thinking as well as doing," he said.

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