WASHINGTON — Partially in response to survey findings showing the public's low confidence in the Food and Drug Administration, Congress is considering giving the agency more authority over the pharmaceutical companies it deals with, but some legislators are warning against doing too much too fast.
The survey of 1,000 adults nationwide was performed by pollster Celinda Lake and sponsored by a coalition of consumer groups. The results showed that only 14% of respondents had a great deal of confidence in the agency's ability to ensure the safety of prescription drugs. And 48% of respondents believed the FDA was too influenced by the industries over which it has jurisdiction.
Sandra Kweder, M.D., deputy director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, told the Senate that in order to ensure drug safety, it would be helpful if the FDA had more clout. At a hearing on FDA oversight she noted that it took more than a year and a lot of back-and-forth haggling just to get warnings added to the Vioxx label.
Sen. Edward Kennedy (D-Mass.), also spoke in favor of giving the agency greater labeling authority. “The FDA needs clear authority to require relabeling of a drug after approval once a risk is found,” he said.
Some observers noted that such changes would only go so far. “We all know product labeling does not change provider behavior very much,” said Arthur Levin, director of the Center for Medical Consumers in New York and the consumer representative on the FDA's Drug Safety and Risk Management advisory committee. Even if FDA does get more labeling authority, “we shouldn't count on it protecting the public from harm,” Mr. Levin said at a teleconference on the survey results.