FDA LOSING ITS GRIP ON DRUG SAFETY, REPORT CHARGES

Pharmacy Times, Volume 0, 0

The Institute of Medicine (IOM) has raised serious concernsabout the FDA's ability to ensure the safety andintegrity of the US drug supply. In a report to the USDepartment of Health and Human Services, the IOM concludedthat "serious resource constraints" have "weakenedthe quality and quantity of the science that isbrought to bear on drug safety."

The IOM warned that "a perception of crisis has compromisedthe credibility of the FDA and of the pharmaceuticalindustry."

The institute called for a series of steps, including a"large boost in funding and staffing for the agency" anda heavier emphasis on monitoring the safety of drugsafter they have been approved for marketing. The reportalso called for stricter labeling requirements and advertisinglimits for new medications, as well as "mandatoryregistration of clinical trial results to facilitate publicaccess to drug safety information."

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