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Critics say FDA in danger of losing public trust

The FDA was criticized for under-reacting to safety concerns about Vioxx, and is now under fire for perhaps over-reacting to Aleve. Has the agency that's supposed to protect the public lost its way? NBC's Tom Costello reports.

Dr. Jerry Avorn wears many hats at Harvard University. He's a veteran medical school professor and a published author on the drug industry. But right now, he fears the Food and Drug Administration is in danger of losing the public's confidence.

"We've gone from denying risks where they existed to worrying people about risks about some of the most commonly used drugs in the country," says Avorn. "[All] on the basis of data that no one has gotten a chance to take a look at."

The FDA has been under fire for months — from congressional hearings to a whistler blower who says the FDA isn't cautious enough.

"When the FDA says a drug is safe and effective, they've got it half right," says FDA whistle blower David Graham. "The drug works, but it's not necessarily safe."

And now — concern about anti-depressants, Vioxx, Celebrex and Aleve.

On Tuesday, former FDA commissioner David Kessler admitted he's concerned.

"Yes, there are real questions that go to the agency's credibility," says Kessler. "But there are very dedicated individuals that are trying very hard to protect the public health."

And, says Kessler, the FDA needs to do a better job of monitoring the drugs already on the market. Americans spend $216 billion each year on prescription drugs. Nearly half the population is on at least one medication. And as that figure has risen dramatically over the last ten years, Americans have come to rely on the FDA to ensure that the medicine they're taking is safe.

But the FDA's Dr. Janet Woodcock says the public needs to understand something very basic.

"You have to realize that all drugs have side effects," says Woodcock, the acting FDA deputy commissioner.

Woodcock says long-term drug studies can take 20 years — time many patients don't have.

"We are going to find new side effects of drugs after they're approved unless we're willing to wait 20 years before getting new drugs on the market," she says.

With 10,000 drugs currently available in the United States, the issue is the public'strust in the FDA.

"If that climate of trust has been contaminated, it's going to take years to get it back," says Avorn.