GOTTLIEB: FDA OVERSIGHT NOT AFFECTED BY CRITICISM OF SAFETY DECISIONS
Recent criticism of the FDA's handling of drug-safety issues has not made the agency too conservative in its oversight of drugs, but attacks on advisory committee members could affect the FDA's ability to hold frank scientific discussions, says a top agency official.
Scott Gottlieb, the FDA's new deputy commissioner for medical and scientific affairs, rejects claims that the FDA has responded to critics with a new sense of caution and that the agency has changed its drug regulation strategy.
A recent report in The New York Times suggested the FDA has tightened enforcement, noting that so far this year the agency has issued twice the number of public health advisories on drug risks than it did during all of last year. Drug applications in the first half of 2005, meanwhile, took almost twice as long to win approval as they did a year ago, according to the Times.
"I don't think you can extrapolate from anecdotal data to try and draw a conclusion that the agency is skewed in one direction," Gottlieb told FDAnews. "I don't think the agency moves in a sort of monolithic fashion in one direction or another."
FDA divisions typically face different problems and make decisions based on the information they have, he said. "I don't get the sense that there has been a dramatic change in the internal environment in terms of the careful work people do and the science-based approach they bring to the job."
Still, firms have expressed concern the FDA will raise approval standards and lower the threshold for withdrawing drugs when safety issues arise. Other top FDA officials have tried to allay such fears, noting the FDA's top priority is to strike the right balance between evaluating risks and benefits, not follow the fashion of the moment.
What concerns Gottlieb the most, however, is the recent criticism aimed at FDA advisory committees. "I worry that attacks on [panel members] could inhibit their ability to have frank, open scientific discussions in public," said Gottlieb, who declined to give specific examples.