FDA Will Have New Drug Oversight Safety Board

On the close of the first day of governmental hearings on the safety of some of the nation’s most popular painkillers, the Health and Human Service Department has announced it will create a new body within the Food and Drug Administration to monitor the safety of drugs already on the market.

"The public has spoken and they want more oversight and openness," said Health and Human Services Secretary Michael Leavitt. "They want to know what we know, what we do with the information and why we do it."

The move comes from the FDA administration, the agency responsible for the regulation of prescription and over-the-counter drugs in the U.S., as they are facing intense criticism on its follow-through monitoring of drugs once they are approved for sale to the public.

A new, independent monitoring board within the FDA, called the Drug Oversight and Safety Board is being formed. The board will be comprised of experts from the FDA, research groups, patients, and consumer advocates. Medical experts from other government agencies will also sit on the new board.

Lawmakers such as Senate Finance Committee Chairman Senator Charles Grassley have urged a separate agency to keep track of approved drugs after they are in the marketplace.

"A new drug safety board may contribute to oversight of the Food and Drug Administration. It remains necessary that the drug safety office within the FDA be made a truly independent entity from the office of new drugs," said Grassley. "I'm drafting legislation to clearly establish this independence and provide the office the authority needed to do its job."

"The steps announced today… are an overdue step forward, but they don’t go nearly far enough. It is critical that FDA’s resources to monitor drugs be dramatically increased, and the FDA must be given the authority to require drug companies to initiate and complete appropriate safety studies," said Senator Edward Kennedy.

One problem is that the FDA cannot simply recommend that drug companies go and run clinical trials to study specifically whether a painkiller drug can trigger a heart attack or stroke.

This is because it is generally seen as being medically unethical to test a drug on patients where they would receive no real medical benefit and run the risk of being significantly harmed. And even if such drug trials were approved by the FDA, it would be very difficult to get doctors to recommend patients for such studies.

Because of this, many industry watchers now believe the FDA panels will recommend imposing new labeling on all Cox-2 painkiller drugs warning that long-term use can cause cardiovascular problems. Some even foresee the FDA recommending that all non-steroidal anti-inflammatory drugs (NSAIDs), even ibuprofen, be labeled as such.

"I think it will be very difficult for any of those drugs to remain on the market without some re-labeling, at least warning of cardio risks," says Robert Hazlett, an analyst for Sun Trust Robinson Humphrey.

If any one drug is in danger of being removed from the market, it will be Pfizer’s Bextra®, experts say, which already carries two black box warnings, one for a dangerous skin reaction and the other for cardiovascular risk to patients who have recently had heart surgery.

"The data for Bextra® is a little less convincing," said Hazlett, on the chances of Bextra® remaining on the market. "Bextra® is clearly at higher risk."

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