Regulatory Focus™ > News Articles > Barraged by Drug Ads? FDA Wants to Know How That Makes You Feel—About the Drug

Barraged by Drug Ads? FDA Wants to Know How That Makes You Feel—About the Drug

Posted 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.

Background

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:

Date	Topic	Study Summary
January 2012	Corrective Advertising	Study to assess whether and how corrective advertising—used to correct information in a previous ad—works.
October 2012	Promotional Ads and Healthcare Professionals	Study to assess how advertisements and promotional materials affect prescribing habits.
May 2013	Composite Scores	Study to assess whether and how consumers understand "composite scores" used in DTC advertising.
July 2013	Health Information Availability	Assessment of how consumers find health information about prescription medication
October 2013	Adolescents and DTC Advertising	Study to assess how adolescents interpret drug risk in DTC advertising
February 2014	Alternate Format for Major Risks in DTC Drug Ads	Proposed study of whether FDA should allow DTC ads to contain only the major risks associated with a drug.
May 2014	Distractions in DTC Advertising	Study to assess whether "distractions" in DTC advertisements can make a drug seem safer than it is.

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.

New Study Proposed

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.