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Regulatory News | 10 November 2014 | By Alexander Gaffney, RAC
There's no shortage of pharmaceutical advertising on US television stations. Watch a TV show for long enough, and chances are good you might even see the same drug ad several times. Now the US Food and Drug Administration (FDA) says it's interested in studying whether consumers who view the same drug ad multiple times perceive the safety or efficacy of the advertised drug differently than those who view it only once.
FDA frequently undertakes studies on direct-to-consumer (DTC) advertising, and specifically how consumers view and interpret advertising. A brief overview of studies undertaken by FDA is as follows:
FDA's various studies have focused in large part on the ways in which consumers view DTC advertising, and how a wide range of factors can impact their assessment of a drug's benefits and risks.
FDA's latest proposed study, announced in a 10 November 2014 Federal Register announcement, isn't much different in this regard.
The study, entitled "Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads," seeks to test FDA's hypothesis that consumers who view the same drug advertisement multiple times will have a slightly different view of the product each time.
FDA's Register notice explains that various studies on consumer behavior have indicated that an advertisement viewed twice "generates better recall that a message broadcast only once." Other studies have shown that ads viewed multiple times also serve to "improve product attitudes and recall for product attributes."
For regulators, that information is potentially concerning. Drug advertisements are intended to portray an accurate assessment of a product's benefits and risks, which is ensured through FDA's enforcement of its "fair balance" standard. Under the standard, companies must devote equal time, prominence and space to a drug's benefits and risks.
That stands in stark contrast to most advertising for consumer products, which focuses exclusively on a product's benefits.
Implied by FDA in its notice is a concern that if a drug company bombards consumers with advertisements, it might succeed in making its product seem safer than it actually is.
That implied hypothesis, though, may not be correct. FDA notes that the prominent presence of risk information in its advertising may serve to blunt the potentially positive effects or repeated advertising. After all, each repeat advertisement is not only serving up information about a drug's positive attributes, but also its most serious safety risks as well.
As FDA explains, it just doesn't know how repeat pharmaceutical advertising affects consumers, because research in this area has never before been conducted.
Accordingly, the agency says it is proposing to study the issue with a three-arm trial involving a 42-minute TV program embedded with either one, three or six advertisements for the same drug ad. The 620 study participants will then be asked questions designed to assess their "perception, memory and judgments about the ad," FDA said.
Tags: DTC Advertising, Study, FDA Study on DTC Advertising