FDA asks if mix of product and disease info confuses consumers
In a Federal Register notice yesterday, the agency outlined a planned study (“Experimental Study: Disease Information in Branded Promotional Material”) looking into those questions. The study will feature print ads discussing three conditions – COPD, lymphoma and anemia – to be reviewed electronically by 4,650 American adults.
The Federal Register notice summed up the agency's concerns thusly:
“in some cases a full description of the medical condition may include information about specific health outcomes that are not part of a drug's approved indication …. When broad disease information accompanies or is included in an ad for a specific drug, 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. For example, the mention of diabetic retinopathy in an advertisement for a drug that lowers blood glucose may lead consumers to infer that the drug will prevent diabetic retinopathy, even if no direct claim is made. 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 …. If consumers are unable to distinguish [between product and disease info], then consumers may be misled into believing that a particular drug is effective against long-term consequences.”
The study will examine two variables: the type of disease information presented in an ad, whether discussing possible disease outcomes or not, or excluding disease information altogether; and how the information is presented, whether separate from or integrated into product claims. Some ads will contain info about disease outcomes for which the drug is not indicated, while others will see disease info that “mentions consequences of the disease that go beyond the indication of the advertised product.” A third group will see no disease information at all. Disease info may be presented in alternating paragraphs, on separate pages or in different fonts and colors from product claims.
The Office of Management and Budget is accepting comments on the proposed study through July 20.