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FDA seeks authority to demand warnings on drug labels

WASHINGTON—Users of the painkiller Vioxx were kept in the dark for more than a year about the drug's potential dangers because the Food and Drug Administration lacked the authority to demand safety-related changes in the product's labeling, an agency official told Congress on Tuesday.

In testimony before the Senate Committee on Health, Education, Labor and Pensions, Sandra L. Kweder, the FDA's deputy director for new drugs, said it would be "very helpful" if Congress gave the FDA the authority to require drug makers to include cautions on a drug's label when problems are first documented.

Kweder also recommended that the FDA be allowed to require drug companies to conduct clinical trials when concerns arise about the safety of drugs already on the market.

Alan Goldhammer, a regulatory affairs specialist at the Pharmaceutical Research and Manufacturers of America, the drug industry's Washington trade group, said in an interview that drug companies generally agree to label changes promptly, so no new FDA authority is needed. He said the industry was still considering its position on FDA-required clinical testing for drugs already in use.

The FDA has faced fierce criticism in recent months for waiting nearly a year to require stronger warning labels for antidepressants after studies indicated the drugs caused suicidal tendencies in children and teens. The agency was also accused of ignoring concerns about the side effects of Cox-2 inhibitors such as Merck & Co.'s Vioxx and other such painkillers linked to heart problems and strokes.

Kweder said the FDA had safety concerns about all Cox-2 inhibitors, particularly Vioxx, when applications for the drugs began coming into the agency in the late 1990s. Popular with arthritis sufferers, Cox-2 inhibitors, such as Celebrex and Bextra by Pfizer, are designed to be easier on the stomach than older pain relievers.

But when a 2000 study suggested that Vioxx might increase the risk of heart attack and stroke, it took from February 2001 until April 2002 for the FDA and Merck to agree on a warning, Kweder acknowledged.

"They rejected many of our proposals and we similarly rejected many of the proposals they sent to us," Kweder said. "We don't have the authority to tell a company, `This is how your label has to look. This is the language that needs to go into your label.'"

In addition, Kweder said the agency did a poor job of informing doctors about Vioxx's possible side effects after the warning label was required.

Sen. Mike Enzi, R-Wyo., the committee chairman, and Sen. Edward Kennedy, D-Mass, the panel's senior Democrat, are considering legislation to strengthen the FDA's regulatory powers. They want to balance the need for safe drugs with patients' need for a variety of drug therapies.

"We will not pre-determine our response," the senators said in a joint statement. "Overreacting could be as dangerous as doing nothing, so we must take extraordinary care to find the right approach."

On Tuesday, Sens. Christopher Dodd, D-Conn., and Charles Grassley, R-Iowa, introduced a bill to require public disclosure of all new clinical drug trials. It's intended to thwart drug company efforts to hide or downplay studies that reveal safety problems with their products.

The FDA recently proposed launching a drug watch Web page that would provide consumers with information on drug safety, risks and possible side effects. Had that been available in 2000, Kweder said, consumers would have been alerted to concerns about Vioxx "well in advance of the labeling change being worked out. It would have been very, very useful."

The FDA is also considering creating a drug safety oversight board that would be independent of the agency's drug approval offices.

Kweder denied that the FDA's recent focus on faster drug approvals had hurt its efforts to protect patients. She also defended the agency's selection of members for a recent advisory panel on Cox-2 inhibitors who had financial ties to drug makers.

Kweder said the FDA had picked a fair panel but that conflicts were hard to avoid because 31 companies make Cox-2 inhibitors or the painkillers that compete with them.


(c) 2005, Knight Ridder/Tribune Information Services.

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