June 21, 2012 – The Food and Drug Administration (FDA) announced yesterday that it intends to study whether providing disease awareness information in branded full product advertisements affects consumer perceptions of the product.

In a June 20 Federal Register notice, the agency stated that although some research has shown that disease awareness advertising “is viewed by consumers as more informative and containing less persuasive intent than full product advertising,” when that information is included in branded product ads, “a full description of the medical condition may include information about specific health outcomes that are not part of a drug’s approved indication.”

“Although the FDA can investigate these matters, it might be better to study the behavioral response to both disease awareness and product advertising, as well as the value of ads to educate and better inform,” said Coalition for Healthcare Communication Executive Director John Kamp.

Arnie Friede, former Senior Corporate Counsel at Pfizer, Inc., and a former Associate Chief Counsel in the FDA Chief Counsel’s Office, told the Coalition that “there is an important opportunity here to stake out a position on the utility from a public health standpoint of advertising that couples disease awareness information and product promotion and to argue that FDA should revisit its enforcement policy on the matter even as it undertakes and evaluates the consumer survey,” he said. “This is also consistent with Commissioner Hamburg’s position that industry ought to consider doing more disease awareness advertising.”

The agency is concerned

that “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.” The FDA notes that if consumers have difficulty distinguishing between disease awareness information and branded drug product claims, consumers “may be misled.”

The study that the FDA is proposing to conduct will explore perceptions that result from including both disease information and promotional information about a specific drug in the same advertising piece. Two variables will be examined in the study: (1) the type of disease information (possible disease outcomes, versus non-outcome information, versus no information); and (2) the format of the information (integrated with drug information versus separated).

Although a comment sent in

response to an Aug. 16, 2011, notice for public comment requested that any survey questions related to behavioral intention be deleted, the FDA states in the notice that its  Risk Communication Advisory Committee (RCAC) has recommended that behavioral intention is an important variable to measure in research studies on promotion. [Editor's
note: The RCAC is slated to meet again on June 29 from 8 a.m. to 3 p.m.]

“What is most important now is developing public policies that enable optimal use of life enhancing and life saving medicines,” Kamp said. “It’s time to focus on more effective ads, leading to safe, effective use and better adherence, rather than just focusing on problems with ads.”

Comments regarding the proposed study are due to the FDA by July 20.