Pharmaceutical Business review

FDA asked to include side effects data in TV drug ads

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.

Drug safety campaigner Kim Witczak, who co-authored the citizens’s petition, said: “Drug ads are everywhere; shouldn’t giving people an easy way to report a problem with their medications be equally available?”