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The Consumer Union advocacy group has petitioned the FDA to require television prescription drug advertisements to include a toll free number and a website address where consumers can report adverse events to the FDA. The petition was filed late in 2007 and has so far obtained 56,000 signatures of consumers in support of the petition.


A federal law passed last fall expands the FDA’s ability to police drug safety and included a tidbit on this front. It said print drug ads must include “in conspicuous text” the following: “‘You are encouraged to report negative side effects of prescription drugs to the FDA. Visit, or call 1-800-FDA-1088.’” It also called for the Department of Health and Human Services to conduct a study on whether such a statement would be appropriate in TV ads.


A survey released by the Consumer Union indicated that 35 percent of the polled consumers were aware that adverse reactions could be reported to the FDA. The aim of the petition is to in crease this number and provide consumers easier and more effective access to the channels used to report adverse events.

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