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MedWatch info for DTC ads

Executive Summary

Reps. Janice Schakowsky, D-Ill., and Rosa DeLauro, D-Conn., stress the need for FDA to include a toll-free number and Web site in TV drug ads at a media briefing April 2, following the same-day release of a Consumers Union petition. Consumers Union cites the agency's failure to complete a study on whether TV ads should contain MedWatch reporting information, initially due at the end of March. DTC provisions in the FDA Amendments Act require adverse event reporting information on print ads, though pending legislation by the representatives may subject TV ads to tighter regulations (1"The Pink Sheet," March 3, 2008, p. 10)

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