FDA Urged to Toughen Diabetes Drug Tests

摘要：July 3, 2008 -- Drug companies should be required to conduct stricter safety tests before marketing new diabetes drugs, expert advisors tell the FDA。 “We heard they wanted us to have greater certainty and assurance before approval about the cardiovascular effects of the drugs, and that they ......

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July 3, 2008 -- Drug companies should be required to conduct stricter safety tests before marketing new diabetes drugs, expert advisors tell the FDA.

An expert committee has urged the agency to require companies to screen diabetes drugs for heart attack risk before they can be approved, or to require longer safety testing after the drugs are on the market.

The move comes after Avandia, a drug for type 2 diabetes, has come under scrutiny because of evidence it may raise heart attack risks by as much as 40%.

"We heard they wanted us to have greater certainty and assurance before approval about the cardiovascular effects of the drugs, and that they wanted us to ensure that the question was ultimately answered either before approval or after approval," says John Jenkins, who directs the FDA's Office of New Drugs. "It's a higher level of understanding and a higher level of assurance that you've excluded unacceptable cardiovascular risk."

The FDA put new warnings on Avandia last year. It was allowed to stay on the U.S. market despite calls -- including from some FDA officials -- that it be pulled from sales.

The experts' recommendations only apply to new type 2 diabetes drugs. Agency officials say they will have to decide whether to require longer safety studies before approval, more detailed follow-up trials once drugs are on the market, or both.

"It really will ultimately require us to look at each individual drug," says Mary H. Parks, MD, director of the FDA's Division of Metabolism and Endocrinology Products.

All drugs have risks. But FDA officials have not yet determined what would qualify as an "unacceptable risk" for diabetes drugs.

As many as 24 million Americans suffer from type 2 diabetes; it's a leading cause of death and disability.

Jenkins says some heart risk could be deemed acceptable if a drug is shown to be highly beneficial. Drugs with only "marginal" benefit likely won't be allowed on the market if testing shows they raise cardiovascular risks, he says.