REGULATORY FOCUS: FDA Members Testify on Drug-Warning Labels

High-ranking agency officials disagree over need for increased authority.

Ben Van Houten, Managing Editor

Although a senior FDA official recently told Congress that the agency seeks more authority to author drug-warning labels, a higher-ranking commissioner within the organization has taken the opposite view.

Sandra Kweder, deputy director of FDA's Office of New Drugs, told Congress in March that more warning-label authority would likely help put a stop to label disputes with pharmaceutical companies, such as the one that reportedly delayed warnings to a popular arthritis drug's users about potential heart problems.

Kweder told the Senate Committee on Health, Education, Labor, and Pensions (HELP) that Congress would be "very helpful" if it gave FDA authority to issue mandatory drug-warning labels and to require tests of pharmaceutical products that are considered highrisk.

However, Janet Woodcock, FDA's acting deputy commissioner for operations, told the same committee that the agency in fact does not require such new authority from Congress. Instead, Woodcock stated that the agency wants to move faster to identify potential side effects of drugs in use and to work harder to get drug-safety warnings to patients and physicians.

Woodcock, speaking just days after Kweder, testified that FDA actually had no official position on whether it needed new drug-regulation authority. She also reported that the agency wanted to see the recommendations of an Institute of Medicine study panel on how to improve FDA drug-safety oversight. According to published reports, that panel is slated to begin its work later in 2005.

Woodcock also stepped back from two recent congressional reform proposals. One proposal would have allowed FDA to force drug companies to accept changes in warning labels. The other would allow the agency to require companies to conduct clinical trials when concerns arose about the safety of drugs already on the market. "We are now planning to put information out directly to the public on emerging safety issues," Woodcock said. This, she said, would probably eliminate the need for new warning labels or testing authority.

Woodcock added that FDA's proposed Drug Watch Web site would publish new safety data and test results prior to any label changes being made.

Woodcock added, "If there's a need for additional studies to be done, it's going to become quite apparent as we communicate the safety information."

Alan Goldhammer, regulatory-affairs specialist at the Pharmaceutical Research and Manufacturers of America (Washington, DC), thinks that Woodcock is correct in stepping back from Kweder's position on warning labels. "Pharmaceutical companies have generally agreed to label changes quickly, so no new FDA authority is needed," he says. "In addition, industry is still considering its position on FDA-required clinical testing for drugs already in use."

However, one prominent member of Congress, Senator Edward Kennedy, (D–MA), seems to agree with Kweder. Kennedy recently stated that he supported giving FDA the additional power to require product-label changes and more clinical trials of potentially unsafe medications already in use. Kennedy also said additional money should be given to FDA's budget to increase drug monitoring, and he encouraged allowing the agency to require postapproval studies.

FDA in general has had to deal with widespread criticism over the past few months. First, it has been criticized for waiting almost a year before requiring stronger warning labels for antidepressants after studies had shown links between some drugs to suicidal tendencies in children. The agency was also criticized for taking more than a year to finish negotiation of warning-label revisions with the maker of the arthritis drug that was linked to heart problems and strokes. However, FDA has also increased its staff for drug reviews, which currently take about 12 months for regular drugs and six months for priority drugs.

No votes yet