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    Holes in U.S. Drug Safety Net

    Consumer Reports: Drug Approval, Follow-Up 'Flawed'

    After Drug Approval: Patient Beware continued...

    three to six months to catch up with the ad. By that time, the damage is done. You need an approval system before, not after the ads hit the media. They should submit copy for vetting by the FDA, and the FDA needs resources for this. They don't have the personnel or the money."

    The Consumer Reports article notes that PhRMA in August 2005 announced guiding principles for direct-to-consumer ads, including a wait before advertising new drugs. As of November, the article reports, most of PhRMA's 33 members had signed on.

    Independent Drug Safety Board Needed?

    Currently, the FDA's drug-safety office is one of 12 subgroups reporting to the director of the FDA's Center for Drug Evaluation. It's been lacking a permanent chief for some time.

    Lipman says there should be a drug safety office -- with regulatory teeth -- outside the FDA.

    "What is really needed, in our opinion, is an independent office of drug safety: nonbiased safety experts not part of either the pharmaceutical industry or the FDA," he says. "The same people can't be responsible for drug approval and drug safety. It just makes it that much harder for a drug to be withdrawn by the people who approved it."

    Gardner isn't so sure. He thinks that a drug safety office would be no better than the expert advisory panels that currently advise the FDA. Instead of a new layer of bureaucracy, he would like to see more power given to these panels of experts.

    PhRMA's Trewhitt doesn't see the need for any of this. "Simply put, the FDA still has the world's best drug safety record," he says.

    Institute of Medicine to the Rescue

    Lipman, Gardner, and Trewhitt all praise one thing about the FDA. The agency already has asked for help. Last year, it turned to the independent Institute of Medicine (IOM) for advice. An IOM committee has since been holding hearings. Its recommendations are expected in July 2006.

    "The FDA has asked the IOM to thoroughly investigate the drug safety system," Trewhitt says. "It would behoove us to wait to see the results."

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