Drug Side Effect Warnings May Be Cut From Future Television Ads

A new report suggests that those long lists of potential drug side effects announced during television advertisements, may actually work against the consumer and cause serious health risks to be overlooked.

As a result of the risk that consumers may tune out the warnings altogether, federal health regulators are now considering loosening requirements that all relevant side effects be listed in drug commercials and other advertisements.

Today, the FDA will ask for public comment on a proposed rule (PDF) that would only require drug manufacturers to only announce serious drug side effects in direct-to-consumer (DTC) ads.

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“There is concern that as currently┬áimplemented in DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects,” the proposal states. “At the same time, there is concern that DTC TV ads do not include adequate risk information or leave out important information.”

The FDA says those are conflicting viewpoints that could be solved by limiting the side effects portion of the ad, known as the “major statement” to just those that are “serious and actionable.” There would also be some sort of statement that alerts the consumer that there are more potential, less significant, side effects and that they should review them with their health care provider.

The proposal and call for public comments is scheduled to be published in the federal register today. The public will have 60 days to comment.

Eventually, the FDA plans to survey about 1,500 people on drug risks and see how well they understand the risks due to DTC ads. The pharmaceutical industry spent about $3.1 billion on such ads in 2012.


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