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Drug safety reform at the FDA
New England Journal of Medicine, 4-13-07

McClellan calls for an active drug surveillance system at the FDA that could help rapidly update patients and doctors on emerging safety concerns.

One key reason drugs may be used for years by millions of patients before risks become evident is that the United States has no active drug-surveillance system.

The FDA relies on its Adverse Event Reporting System (AERS), which involves the investigation of "spontaneous" adverse-event reports from health professionals, drug manufacturers, consumers, and others. AERS is important, but even with planned improvements, it captures only a small fraction of adverse events.

With almost all prescriptions now processed electronically, and with the availability of increasingly detailed data on health care utilization and outcomes for insured Americans, we could implement a routine, systematic approach to active population-based drug surveillance that could identify potential safety problems much more effectively and relatively inexpensively.

For example, Richard Platt, a professor of ambulatory care and prevention at Harvard Medical School, has noted that with a (now feasible) data network including information on 100 million patients, a statistically significant "signal" of serious cardiovascular risk could have been detected after less than 3 months of experience with rofecoxib. Such an electronic surveillance network would also help in targeting follow-up clinical studies to determine causality when necessary and follow-up actions to influence prescribing.

Although substantial disagreements remain about some aspects of reform, now is the time for Congressional action on drug safety. Several conclusions are clear. First, the FDA needs more resources, and the only feasible way to provide them this year is a combination of greater user fees and the maximum possible increases in federal appropriations.

Second, new regulatory authority or organizational changes may help, but the promise of such reforms should be weighed against their potential deleterious effects on access to treatments.

Finally, it is possible to implement a much more systematic approach to postmarket monitoring of drugs and to promoting the effective use of medications, by augmenting FDA resources with the rapidly growing array of electronic resources related to drug use. Such an approach will help to minimize the safety problems and scientific disagreements that accompany prescription drug use when evidence is limited—without pushing the pendulum toward excessive restrictions on access to valuable drugs.

Project FDA.
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