Congress Mulls Increase in FDA Authority

Joyce Frieden

WASHINGTON -- Congress is considering giving the Food and Drug Administration more authority over the pharmaceutical companies it deals with, but some legislators are warning against doing too much too fast.

"Changes to drug safety ... must be carefully considered to make sure they don't unduly impact patient access," Sen. Mike Enzi (R-Wyo.), chair of the Senate Health, Education, Labor, and Pensions Committee, said at a hearing on FDA oversight.

"Congress needs to engage in strong oversight to maintain public confidence in the FDA," he added.

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 committee that in order to ensure drug safety, it would be helpful if the FDA had more clout.

She noted that it took a lot of back-and-forth haggling just to get some earlier warnings added to drug labels.

"The most important lapse [with the safety concerns surrounding Vioxx] was the delay it took to get the information into the labeling; it took over a year," she said. "I think stronger ability to require changes in labeling would be very helpful."

The committee's ranking member, 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. "Negotiations with the drug company should never delay [that]."

Some observers said that although giving the agency more authority over label changes is a good idea, it only goes 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.