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FDA asked to include side effects data in TV drug ads

www.pharmaceutical-business-review.com

US legislators have urged the FDA to include all the information regarding the ways to report to the Agency of the side affects of the advertised drug in all the television advertisements, according to PharmaTimes.

A Consumers Union (CU) survey in the US found that only 35% of the public were aware that they could report serious drug side effects to the FDA. In 2007, the CU presented a citizens's petition to the FDA asking it to require all TV ads for both prescription and over-the-counter medicines to include a toll-free number and web address so that the public could easily report adverse events.

In September, 2007, the US Congress approved a major drug safety bill that required all drug print ads to include, 'in conspicuous text', the statement: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088." But this legislation left it to the Department of Health and Human Services to carry out a study to determine if such information should also be included in TV ads.

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