The Food and Drug Administration's seal of approval is looking a little tarnished these days, what with the painkiller Vioxx being withdrawn from the market three years ago for doubling the risk of heart attack and stroke and recent reports that the diabetes drug Avandia increases heart problems, too. Indeed, the number of serious drug reactions reported to regulators reached nearly 90,000 in 2005, nearly three times the number of 1998 reports, according to a study published last month. The number of events increased four times faster than the number of outpatient prescriptions. And experts say that those numbers don't come close to telling the whole story, since the current voluntary system—which relies on health professionals and others to report drug problems—flags only a fraction of the problems that occur. An Institute of Medicine report on the FDA released last fall painted a dire picture of chronic underfunding, insufficient data on drug risks and benefits after approval, and a lack of clear authority to tell the drug companies what to do.
But the tide may now be turning. A new law signed by President Bush in September and hailed by consumer advocates as the most significant drug safety legislation in more than 40 years substantially expands the agency's power at a time when the scope and complexity of its tasks are growing rapidly. New drugs are introduced more quickly, for example, and in addition to traditional chemical compounds the drug regulator must review and track biotechnology medications produced by living cells as well.
The new law directs the FDA to create a new computerized database that will routinely scan the records of insurers, doctors, and others to identify drug safety problems and monitor trends. "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 recently published adverse drug event study. "It would be a huge step forward if it can be done accurately."
The law also gives the FDA more control over the information consumers and providers receive about approved drugs. It gives the agency authority to order drug manufacturers to make changes to drug labels rather than negotiate them and to fine drug companies for false or misleading ads. The law also requires drug companies to post all clinical trial data for approved drugs and medical devices on the existing clinical trials registry.
Funding for the beefed-up safety monitoring will be provided in part by a jump in the annual fees drug companies pay the FDA to speed approval times, among other things. The fees are a bone of contention for many agency critics, who argue that using industry money to regulate the industry creates a conflict of interest. Consumer advocates agree. "We're going to start agitating on funding sources tomorrow," says Bill Vaughan, senior policy analyst with Consumers Union.