/publications/issue/2006/2006-11/2006-11-5990

FDA LOSING ITS GRIP ON DRUG SAFETY, REPORT CHARGES

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The Institute of Medicine (IOM) has raised serious concerns about the FDA's ability to ensure the safety and integrity of the US drug supply. In a report to the US Department of Health and Human Services, the IOM concluded that "serious resource constraints" have "weakened the quality and quantity of the science that is brought to bear on drug safety."

The IOM warned that "a perception of crisis has compromised the credibility of the FDA and of the pharmaceutical industry."

The institute called for a series of steps, including a "large boost in funding and staffing for the agency" and a heavier emphasis on monitoring the safety of drugs after they have been approved for marketing. The report also called for stricter labeling requirements and advertising limits for new medications, as well as "mandatory registration of clinical trial results to facilitate public access to drug safety information."

After Vioxx and several other high-profile drugs were pulled from sale despite being cleared for safety by the FDA, confidence in the agency's abilities has wavered.