FDA Mulling Side Effects HotlineNov 26, 2008 | Parker Waichman LLP The Food and Drug Administration (FDA) will be interviewing over 1,500 consumers, says the Associated Press (AP), in order to determine if television drug advertisements should be required to include a toll-free number consumers can use to report side effects associated with their medications.
And, while this appears to be a sound requirement, opponents feel that the information could “distract” consumers away from important drug safety data, reports the AP. Print ads contain the FDA’s toll-free information, which is now required by law. According to the AP, that law, which was passed last September, called for the FDA to report to Congress about making such information mandatory in TV drug ads. The requirement was supposed to have been met last March; however, the FDA asked for an extension and is expected to begin its study shortly, the AP reported.
In May, MedicineNet.com wrote that health experts serving on an FDA advisory panel suggested that all direct-to-consumer television drug ads include a toll-free phone number for consumers to report adverse side effects. At that time, FDA spokeswoman Rita Chappelle said the FDA would “look at the panel's recommendations and incorporate them into the design of a study to determine the best way to include a toll-free number in TV ads.” MedicineNet.com noted that Chappelle stated that once the study was complete, regulations would be issued and Congressional approval would be needed. "It could take some time. It could take a couple of years," Chappell said at the time.
The AP reported that the FDA discussed plans to conduct a large-scale study to determine if adding reporting instructions would be overwhelming to the viewing public when watching ads that contain medical information. The FDA, in documents it posted online, says that drug "ads are already quite dense when compared with ads for other products …. The risk information should not be compromised by the addition of the toll-free statement," according to the AP.
In the May MedicineNet piece, Chappelle explained that additional study was required since television and print are different mediums. Issues such as at what point in the ad the number should appear, how long the number should remain on the screen, and where on the screen the number should appear, need to be addressed. Consumer comprehension seems to be of most concern.
The FDA plans on showing fictitious ads to the consumer group, who would then be interviewed to determine comprehension levels, said the AP. The study’s launch date has not yet been announced.
According to the AP, critics say current advertising practices create situations in which medications are over-prescribed before full effects are known. They believe that if consumers are told how to report side effects to the FDA, steps can be taken sooner to address safety problems. Right now, notes the AP, consumers generally tell their prescribing physicians of a drug’s problems, but that information is not always carried over to the FDA.