RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > Disease-information Enhanced Advertisements May Be Misleading Consumers, Says FDA

Disease-information Enhanced Advertisements May Be Misleading Consumers, Says FDA

Posted 20 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) seems to be in favor of un-branded disease awareness commercials. In a Federal Register posting on 20 June, the agency says it is aware of research saying consumers find the advertisements both more helpful and less intrusive than branded product commercials, which is in line with the agency's goals to "encourage the communication of accurate health messages." What it's not supportive of, however, is when disease information is included in a branded drug's advertisement in a misleading way.

FDA explains, "consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad by making inferences that go beyond what is explicitly stated in an advertisement." As a result, "the advertisement may imply broader indications for the promoted drug than are warranted, leading consumers to infer effectiveness of the drug beyond the indication for which it was approved."

The agency said it is concerned about consumers becoming misled by the dual-use advertisements, and announced in August 2011 its intent to conduct a study on consumers to determine if they are able to distinguish between the disease information and the medicinal information portions of the advertisement.

FDA said in response to its original Federal Register posting, it received eleven comments regarding everything from the proper sample size, the scope of the survey's questions, the wording of potential questions, the survey population recruited, and the study's design.

After incorporating many of the suggestions, FDA said it now plans to recruit a "general population" of patients diagnosed with either Chronic obstructive pulmonary disease (COPD), lymphoma or anemia to study their knowledge of the outcomes and non-outcomes of a product after watching a "disease information plus" advertisement featuring a branded product for their condition. A control group of participants will watch a similar ad not containing the disease information portion of the advertisement.

Final comments on the proposed study are due by 20 July 2012.

Read more:

FDA - Experimental Study: Disease Information in Branded Promotional Material

Regulatory Focus newsletters

All the biggest regulatory news and happenings.