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FDA seeks more say on drug labels

Regulators want greater authority to dictate warnings

The Food and Drug Administration asked Congress yesterday to give it more powers to dictate the warnings on drug labels, highlighting what critics call a weakness built into the US system for keeping drugs safe.

Sandra Kweder, deputy director of the FDA's Office of New Drugs, made the request at a hearing of the Senate committee that oversees healthcare.

The panel was examining how regulators dealt with Merck & Co.'s arthritis pain drug Vioxx, which remained on the market despite early evidence that patients taking the drug were subject to higher risk of heart attacks and strokes.

Among the focal points were labeling changes that took 14 months to make. In February 2001, an FDA advisory panel recommended stronger warnings on the Vioxx drug label to reflect possible increased risks of cardiovascular problems. But those changes were not made to the label until April 2002, after a round of negotiations with the company. Merck withdrew the drug from the market in September 2004 after a study of high doses of Vioxx affirmed the earlier indications of risk.

Kweder said the FDA needed more authority to dictate label changes in such cases.

''The lapse from my perspective was the delay that it took to get that information into the labeling," she told the Senate Committee on Health, Education, Labor and Pensions. ''A strong ability to require changes in labeling would be helpful."

Congress is considering legislation to tighten rules on how the government keeps track of the safety of drugs after the FDA approves them. The proposals include a bill unveiled Monday that would require drug and medical device manufacturers to report findings of clinical trials in a publicly available database, including potential side effects, funding, and information on test subjects.

As a practical matter, the FDA has strong authority to dictate labeling language before a drug is approved. In such a case, if a drug maker does not accept the FDA's warnings, the agency could drag out approval or reject the drug. But the company is in a much stronger position after it wins market approval.

''Once a product is on the market, it's like a property right," said Robert Nicholas, head of the FDA practice group at McDermott Will & Emery, a law firm in Washington.

The FDA still has strong negotiating clout for label changes, because if a drug company refuses its suggestions the agency could initiate legal proceedings to remove a drug from the market, or it could ask the secretary of the Department of Health and Human Services to declare a drug an ''imminent hazard." But short of those dramatic moves, the FDA's options are limited.

''There are lots of informal routes -- there is jawboning or discussions," Nicholas said.

But drug industry critic Sidney Wolfe, health director for the Washington consumer group Public Citizen, said even without FDA authority to dictate drug label language, the agency can in effect force change if it wants to. For instance, he said that if the agency publicly demanded a ''black-box warning," the most severe safety warning that can be placed on a drug, its manufacturer would have a hard time resisting. Wolfe said he called for a black-box warning for Vioxx in 2001.

''The FDA didn't want to take that seriously," he said.

The drug industry's lobbying and trade group, the Pharmaceutical Research and Manufacturers of America, said it was reviewing Kweder's remarks and did not have a specific reaction. But in general, said PhRMA spokesman Jeffrey Trewhitt, ''We do believe that FDA jurisdiction over product labeling is adequate."

Massachusetts Senator Edward M. Kennedy, ranking Democrat on the Senate committee, said the FDA needs more power.

''FDA needs clear authority to require relabeling of a drug if necessary after approval, once a risk is found," he said. ''Negotiations with a drug maker should never delay accurate information for patients and doctors."

Christopher Rowland can be reached at crowland@globe.com. Material from Globe wire services was used in this report.

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