FDA head sees changes but no slowdown

By Lisa Richwine

WASHINGTON (Reuters) - The U.S. Food and Drug Administration can improve its monitoring of drug safety without slowing the approval of new therapies, FDA Commissioner Dr. Andrew von Eschenbach said on Monday.

Von Eschenbach, in his first media interview since winning Senate confirmation last month, also said he felt the agency had adequate authority to watch for problems with drugs already on the market. Some lawmakers have said the FDA needs more power to police the pharmaceutical industry.

Keeping up with advances in technology while assuring safety will require more rigorous but efficient FDA oversight, von Eschenbach told the Reuters Regulation Summit in Washington.

"Rapid does not mean reckless. I really believe when you apply rigor, discipline and precision, the processes by their very nature don't necessarily need to be slower ... I think we can do it even better and faster," he said.

He said his philosophy was to make the FDA "a bridge, not a barrier" to advances in health care that will be driven by a growing understanding of how medicines work at the molecular level and affect individuals differently.

Von Eschenbach is a cancer surgeon, former National Cancer Institute director and a cancer survivor. At the FDA, he runs an agency that regulates nearly one-quarter of the U.S. economy, including medicines, most foods and medical devices.

The FDA has been battered in recent years by drug safety controversies. Criticism mounted after Merck & Co. Inc. (MRK.N: Quote, Profile, Research, Stock Buzz) pulled arthritis drug Vioxx from the market in 2004 because of a link to heart attacks and strokes.

An Institute of Medicine (IOM) report last September called for an overhaul of the FDA's surveillance of medicines after approval, recommending internal changes and new authority from Congress such as the power to fine companies that fail to comply with requests for post-approval studies.

Von Eschenbach said he believed the FDA had "ample authorities" to assure the safety of drugs and he would look for ways to use the agency's existing power more effectively.

The FDA still is preparing its response to the IOM report, he said, adding that he would announce some organizational changes in the coming months.

At the same time, von Eschenbach said he saw no current need to overhaul the agency's review of drug company television commercials and other advertising, which critics say can venture into hype. He said the FDA could provide more guidance about appropriate ads before they run to help the industry police itself.

"Prevention is far better than trying to fix something or remedy something after the fact ... I think the industry has a role and a responsibility here," he said.

(Additional reporting by Susan Heavey)