Debates on creating the independent FDA drug safety office

U.S. Sen. Judd Gregg said he's not keen on the idea of creating an independent office to monitor drug safety, because it would create "another layer of bureaucracy" at the Food and Drug Administration.

Gregg is stepping down as chairman of the Senate health committee at the end of the year. He said a bigger priority is getting more resources for reviewing and approving new drugs.

But other senators say there ought to be a distinct separation between the FDA office that approves new drugs and the one that monitors drug safety. Both offices currently operate under the purview of the FDA's Center for Drug Evaluation and Research, wrote The Union Leader.

"The scientific standards that (the FDA) applies to drug safety guarantee that unsafe and deadly drugs will remain on the U.S. market," said Dr. David Graham, a 20-year veteran drug safety officer with the FDA. He questioned the safety of five currently approved drugs. Dr. Graham went on to say that the FDA is too easily pushed around by pharmaceutical companies.

Dr. Graham complained that the FDA failed to heed warning signs that the blockbuster arthritis drug Vioxx caused heart problems. He estimated that as many as 55,000 Americans have died from stroke or heart attack as a result of taking Vioxx, which stayed on the market for at least four years after the problems first surfaced, reports Houston Chronicle.

In a sharp criticism of the current monitoring system, the editors of the Journal of the American Medical Association this week called for considering a new board, independent of the FDA, that would track the safety of drugs and medical devices once they were on the market and in wide use.

The system of FDA oversight "requires a long-overdue major restructuring," the journal said in an editorial. Until then, it said, "the United States will still be far short of having an effective, vigilant, and trustworthy system", informs Boston Globe.

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