FDA Chief Says His Agency Will Be More Proactive on Health Issues

WASHINGTON — The head of the Food and Drug Administration said Friday his agency plans to take a more proactive role in protecting the nation's health and called on Congress to adopt a series of reforms to safeguard food and drugs produced worldwide yet consumed in the United States.

"FDA can no longer simply be a gatekeeper assessing the benefits and risks of products brought before us," Commissioner Andrew C. von Eschenbach said in a speech to the National Press Club.

Instead, the agency intends to establish a worldwide inspection and regulation network that will monitor foods, drugs and medical equipment from production to consumption.

Von Eschenbach urged Congress to pass 10 legislative proposals by Memorial Day that include giving the agency the right to demand mandatory recalls of unsafe food products.

The FDA plans to establish five international offices starting with one in China, which has been the source recently of tainted products including toothpaste, dried apples, seafood and pet food, von Eschenbach said.

Other regional inspection sites will be established in Europe, India, Latin America and the Middle East, he said.

Noting that in the modern international economy seafood can be caught in Brazil in the morning and eaten in Chicago that evening, von Eschenbach said the FDA needs the authority and the means to "regulate products where they are produced, even before they arrive at our borders."

The 102-year-old agency, created at a time when food and drugs were beginning to be mass-produced, faces a critical turning point in its mission, von Eschenbach said.

"The FDA of the 20th Century is not adequate to regulate the food and drugs of the 21st Century," he said. "This is a time in which the winds of change ... are not a gentle breeze but a jet stream."

While advances in science and medicine offer "great promise," they also offer "great peril," von Eschenbach said.

Cloned animals, genetically altered crops and medicines that can alter the molecular structure of cells have the power to provide more food for the world and improve health, but also come with significant risks, he said.

One result of the agency's shift from one that reacts to proposed new drugs to one that takes a proactive role in the development of new drugs is that the number of manufacturers of flu vaccines has doubled from three to six in recent years, he said.

Asked about the aggressive marketing of prescription drugs, von Eschenbach said he was concerned about "inappropriate marketing" techniques and called for the creation of standards to determine what marketing was appropriate.

A former director of the National Cancer Institute and a cancer survivor who wears a yellow wristband sold by the Lance Armstrong Foundation, von Eschenbach reiterated his statement that he believes cancer can be controlled by 2015 if the United States pursues the effort in the way it pursued a Moon landing in the 1960s.

"It is yet to be attained, but it is attainable," he said.

Asked about a comment he previously made about possible tobacco regulation, von Eschenbach again warned that if the government forces tobacco manufacturers to reduce the amount of nicotine in cigarettes, some smokers may smoke more to attain the same nicotine level.