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FDA moves to toughen oversight of drugs

WASHINGTON—Responding to scathing criticism, the Food and Drug Administration offered a blueprint Tuesday to revamp the way it monitors prescription-drug safety.

The FDA recommendations include: establishing an office of chief medical officer to oversee its scientific operations; developing new scientific tools to assess a drug's benefits and risks; improving the collection of data on adverse drug-reaction reports; and creating an electronic system to monitor the safety of drugs that already are on the market.

Other proposals call for finding ways to predict the possible heart risks of new medications, using research on patients' unique genetic makeup to reduce overdoses and publishing a newsletter on findings from studies about drug safety.

Despite the breadth of the changes, health experts said they didn't go far enough to protect people from possibly dangerous drugs.

FDA Commissioner Andrew C. von Eschenbach said these and other proposals weren't "the whole story, nor are they the final chapter." Rather, they represent a "pathway to the future of enhanced drug safety."

While many of the proposals mirror recommendations that the Institute of Medicine, a federal advisory panel, made in a September report, the FDA didn't address some key institute suggestions that would require congressional action.

Notable omissions include recommendations that labels on newly approved drugs display black triangles for two years to warn people that the products' safety is more uncertain than that of older drugs. The FDA also didn't address the institute's call to restrict drug advertisements on these products during the two-year period.

The institute also recommended that drug companies publicly register the results of clinical trials and that the FDA be empowered to require studies on medications already on the market.

"If we're serious about protecting consumers from unsafe drugs, Congress has to give FDA the authority to hold drug companies accountable and perform the safety studies," said Bill Vaughan, a senior policy analyst for Consumers Union.

Von Eschenbach said the proposals addressed "things that were directly within our purview and our sphere of responsibility and influence, while the Institute of Medicine report took a much broader perspective and made recommendations that Congress must approve."

Many found the agency's failure to take a position on some of the institute's key suggestions disappointing.

"The FDA has the ability to go before Congress if they wish and get things done, but instead they chose to dismiss (the suggestions) and say, `They're not for us,'" said Peter Lurie, the deputy director of the Health Research Group at Consumers Union.

While Lurie applauded some of the FDA's proposals, he said that many—such as calls for meetings, pilot programs and advisory committees—"form a guide to bureaucratic stonewalling in Washington."

The FDA did call for a pilot project to analyze the safety of new drugs that have been on the market for 18 months, but critics said those reviews would be inadequate because drug-safety concerns typically emerge after five years.

"Reviewing drugs for safety after 18 months is a good start, but we need periodic, consistent reviews of drugs on the market to catch these major safety issues," said Vaughan, of Consumers Union.

The FDA's proposals follow criticism from health experts and lawmakers that the agency's safety reviews for previously approved drugs are inadequate and endanger public health. That criticism peaked as reports emerged about the FDA's failure to address safety concerns about heart complications posed by popular painkillers such as Vioxx, which was pulled from drugstore shelves in 2004.

In response, the FDA called for the Institute of Medicine to recommend solutions. Its often-scathing report highlighted disagreements about drug safety among FDA scientists, questioned the agency's coziness with the drug industry and said the FDA was poorly funded and lacked the regulatory authority to ensure that prescription drugs were monitored for safety once they'd been approved for sale.

"The agency needs a more nuanced set of tools to signal uncertainties, to reduce advertising that drives rapid uptake of new drugs or to compel additional studies in the actual patient populations who take the drug after its approval," the report said.

Sens. Christopher Dodd, D-Conn., and Charles Grassley, R-Iowa, will re-introduce legislation this week to revamp the safety-review system for previously approved drugs and to expand public access to clinical drug-trial results. Both proposals are in the Food and Drug Administration Safety Act of 2007 and the Fair Access to Clinical Trials Act of 2007. Grassley and Dodd authored similar legislation after the Vioxx incident.

"A mountain of evidence has amassed about the need to improve the way the FDA operates," said Grassley, ranking member of the Senate Finance Committee.


(c) 2007, McClatchy-Tribune Information Services.

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