FDA seeks greater power in writing drug label warningsThe FDA asked congress yesterday for the authority to dictate label changes for drugs to end the type of haggling with pharmaceutical companies that delayed heart risk warnings to users of Vioxx, the Associated Press reported.
The FDA's director for new drugs, Sandra Kweder, told a Senate Committee on Health, Education, Labor and Pensions that the ability to require changes in labels "would be helpful."
"The lapse from my perspective was the delay that it took to get that information into the labeling," Kweder told the panel. "We had to negotiate with the company how the specific language should be worded."
Kweder said it took more than a year for Merck and the FDA to craft a warning about heart risks for Vioxx. Merck rejected several FDA proposals, and the FDA turned down many of Merck's, she said.
The warning was added to the Vioxx label in 2002.
Merck removed Vioxx from the market in September after additional research linked the drug to heart attacks and strokes.
Senators said they are considering whether to give the FDA more authority or to restructure the agency so it can better respond to safety concerns of drugs after they win approval, a Reuters report said.
"Overreacting could be as dangerous as doing nothing, so we must take extraordinary care to find the right approach," Senator Mike Enzi, a Wyoming Republican and the committee's chairman and leading Democrat, Massachusetts Senator Edward Kennedy, said in a joint statement.