The Other Safety Dilemma

The FDA may soon be better at monitoring drugs.

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Legitimate drugs, too, can pose unexpected dangers, as people who suffered heart problems after taking Vioxx or Avandia can attest. The number of serious adverse drug reactions reported to regulators in 2005 was nearly three times the 1998 number, according to a study published last month—and it grew four times faster than the number of outpatient prescriptions. And experts warn that the current system, which relies on health professionals and others to voluntarily report drug problems, flags only a fraction of the total.

But the tide may now be turning. A new law signed by President Bush in September substantially expands the Food and Drug Administration 's power to take action after approval. The law directs the agency to routinely scan large private and government healthcare databases to identify drug safety problems. "This represents an entirely new approach," says Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices and the lead author on the adverse drug event study. "It would be a huge step forward if it can be done accurately." In addition, the agency gains authority to order drug manufacturers to make changes to labels—it's a negotiation now—and to fine them for false or misleading ads. Drug companies, for their part, will have to post clinical trial data for approved drugs and devices on the National Institutes of Health's clinical trials registry. Now, they can be selective.