Panel says new steps needed to ensure drug safety

WASHINGTON — Two years after the withdrawal of the painkiller Vioxx, a dysfunctional Food and Drug Administration (FDA) still can't adequately track the safety of new drugs or respond quickly to problems, a panel of experts said Friday in a long-awaited report.

The report, requested by the FDA, found that Congress, agency officials and the pharmaceutical industry shared responsibility for the problems and bear the burden for implementing solutions.

The 15-member panel of experts in medicine, pharmacology, law and other fields issued a call for change. Included in the panel's 25 recommendations are establishing a fixed term for the FDA commissioner, restricting drug commercials and placing a caution symbol on the packaging for newly approved medications. Some of them would require congressional action.

Consumer groups and advocates of overhauling the FDA hailed the report, while the drug industry was cautious. "Though there is always room for improvements; it would be a mistake to accept the notion that the FDA drug-safety system is seriously flawed," said Caroline Loew, vice president of the Pharmaceutical Research and Manufacturers of America.

The report said the FDA needs more money, people and power to ensure it maintains focus on the safety of the drugs it regulates. The agency needs cultural changes, too, to avoid the tensions that can upset the weighing of drugs' risks and benefits, the panel said.

Problems in FDA oversight were highlighted when the popular painkiller Vioxx was pulled from the market in 2004, five years after its approval, after long-term use was linked to an increased risk of heart attack and stroke.

The report painted the picture of a lopsided agency, with less-than-adequate amounts of time and money being spent on monitoring the safety of drugs once people begin using them in great numbers.

"We found an imbalance in the regulatory attention and resources available before and after approval," said Sheila Burke, chairwoman of the panel. "Staff and resources devoted to preapproval functions are substantially greater."

While praising the panel's effort, Acting Commissioner Andrew von Eschenbach said it will take time to review the findings. "We are at a point where we are assessing and analyzing the report," he said.

The panel operated under the auspices of the Institute of Medicine, part of the National Academy of Sciences, which provides scientific advice to the government.

Material from The Washington Post, The Associated Press and L.A. Times is included in this report.