Healthy Skepticism Library item: 13444

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Taylor L.
FDA told: 'TV drug ads must include side effects info'
Pharma Times 2008 Apr 7
http://www.pharmatimes.com/WorldNews/article.aspx?id=13212&src=EWorldNews

Full text:

US legislators have asked the Food and Drug Administration to require all television advertisements for prescription drugs to include information on how consumers can report any serious side effects with the advertised drug to the agency, including a toll-free phone number.

The FDA is currently “failing to serve its most vital supervisory responsibility” by not providing this information, said the legislators, Democratic Representatives Rosa DeLauro and Jan Schakowsky, who have both sponsored legislation aimed at placing curbs on direct-to-consumer advertising.

They also point out that a recent survey by Consumers Union (CU) found that only 35% of the public were aware that they could report serious drug side effects to the FDA, while just 7% of respondents named the agency as somewhere to which they could report such a problem.

Late last year, the CU presented a citizens’ 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. CU is now collecting petitions to support this requirement, and says it has received 56,000 signatures so far.

Last September, Congress approved a major drug safety bill requiring that all drug print ads should 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.” However, this legislation left it to the Department of Health and Human Services to conduct a study to determine if such information should also be included in TV ads. This study is now underway, and the agency is reviewing CU’s request, Bloomberg has reported.

“Drug ads are everywhere; shouldn’t giving people an easy way to report a problem with their medications be equally available?” said drug safety campaigner Kim Witczak, who co-authored the petition, while CU spokeswoman Liz Foley pointed out that “the average TV viewer spends about 100 minutes watching drug ads for every minute spent in a doctor’s office.”