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Holes in U.S. Drug Safety Net

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

After Drug Approval: Patient Beware

When the FDA approves a drug, it sometimes asks the manufacturer to conduct further safety studies. Consumer Reports notes that in February 2005, companies agreed to 1,191 such studies. Yet as of September 2005, more than two-thirds of the studies were still "pending."

The most important drug-safety experiment comes in the years following drug approval. The subjects of this study: consumers who take the drug.

Preapproval studies enroll no more than a few thousand people -- usually healthier people than many of those who will take the drug after approval. And the studies usually last only a few months. Rare side effects, problems for people with multiple conditions taking multiple other drugs, and long-term side effects can only be seen in the years following approval.

And that, Lipman says, is where the U.S. system breaks down. Doctors are supposed to report any side effects that happen. But because there is no reliable system -- and, Gardner says, because these reports aren't easy to file -- only a small fraction of side effects actually get reported.

Compounding this problem, Lipman says, is direct-to-consumer advertising. Ads heavily promote new drugs. Yet there's a drug risk associated with every drug benefit. And the Consumer Reports article states the ads stress benefits but don't adequately identify risks. "It is impossible to monitor all the ads that are out there," Lipman says. "And more ludicrous, the ad goes into the media, and it takes FDA

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.

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