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FDA's Post-Market Drug Safety Program Called 'Broken'

Paul Brown, consumer healthcare advocate at the U.S. Public Interest Research Group, told CNBC’s “Morning Call” that the Food and Drug Administration’s post-market safety program is “broken.”

He made the comments after new data showed a risk for heart attacks among those using GlaxoSmithKline’s diabetes drug Avandia.

“I don’t know that you want to call it a crisis, but certainly there need to be reforms at the FDA,” Brown said. “(New legislation) requires that most clinical studies be published and available to the public and to researchers and doctors so they can take a look at the risks and benefits of the drugs. Now, if a study by a manufacturer shows the drug is not too beneficial for that company, they hide the study. That’s just plain wrong.”

But John Calfee, resident scholar at the American Enterprise Institute, said Congress might make things worse.

“We’ve been experimenting with getting more clinical trials into the public domain much faster and getting more warnings out,” Calfee said. “It doesn’t always work well. With anti-depressants, the net result of doing this has been to reduce the number of prescriptions and probably to increase the number of suicides.”

He said the FDA “already has so much power that it’s easy for it to do too much” and warned that the pending legislation “will regulate not only drugs, but also the way doctors prescribe drugs.”