Do consumers know where and how to report adverse reactions to the medications they take? Would listing a toll-free number at the end of drug commercials make it easier for them? Would having the number there hinder them from clearly hearing the laundry list of side effects at the end of such commercials?
That's all unknown, so the FDA will be completing a large study about placing a toll-free number for consumers at the end of all direct-to-consumer advertisements to which consumers can report side effects. As part of the study, the FDA will interview approximately 1,600 individuals after presenting them with ads for a fictitious blood pressure medication to determine if the additional information is too overwhelming for them.
Last September, a law passed for print ads that mandated inclusion of FDA contact information on the ads, but there isn't a similar requirement for television ads thus far. However, more severe legislation is under consideration. One example from last spring is a bill that says that during the first three years a drug is on the market, there can be no DTC advertising.
The FDA announced that it will accept comments for the next two months regarding the study, but did not clarify when the study would commence.
One concern: If reporting via toll-free numbers or using MedWatch become commonplace, will FDA and drug companies be inundated with reports of common and relatively harmless side effects? And perhaps a more important question: How will FDA act on the information it receives?