The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising.
The study, announced in a 24 June 2015 posting in the Federal Register, is somewhat similar to other direct-to-consumer (DTC) drug advertising studies proposed by FDA in the last few years, including studies on how adolescents understand risk in drug advertising and how one's spouse might affect one's understanding of drug risks and benefits.
As FDA explains in its Federal Register notice, the elderly often find themselves in a difficult situation: At a time when they are often taking an increasing number of prescription pharmaceutical products to counteract the effects of aging, their ability to understand the benefits and risks presented by those products is often diminished.
For example, the elderly may suffer from a loss of hearing, thereby affecting their capacity to understand speech.
That, FDA explains, is of potential concern to drug marketers, who rely on television advertising to reach many consumers.
"DTC television advertisements (ads) contain large amounts of complex information about prescription drug treatments that may be particularly relevant to a population that is experiencing some level of hearing loss," FDA wrote in its notice. "Moreover, much of the information in these ads is conveyed by voiceover, meaning that the audio channel is the only way to receive the information."
While "closed captioning" options may benefit some consumers, it does not always work (or is not always engaged for) television advertising. Other patients may not realize they are experiencing hearing loss, FDA noted.
While pharmaceutical companies are admittedly not able to control the hearing of their intended audience, FDA said there may be several options available to advertisers to help them "influence the understanding of speech in individuals who experience aging-related hearing loss."
For example, the Register notice observes that while the "major statement" of drug risks is required to be presented audibly, companies aren't required present the major statement visually. Companies might also choose to present risk information more slowly, or even use simplified (i.e. less technical) terms to make them easier to understand.
FDA's study proposes to study factors related to hearing loss in the elderly and their ability to comprehend drug risk factors. Their study will look at several groups of persons ranging from middle-aged (40-50), the "young-old" (60-75) and the "old-old" (75+ years of age). A group of young adults (18-25) will be used as a control group.
"Our primary outcomes will be verbatim and gist memory, and confidence in memory judgments, but we will also seek to apply findings from previous studies showing age changes in hearing ability (Ref. 15 and 16) to the particular situation of DTC ad viewing," FDA said.
Among the factors FDA said it is most interested in learning about is the frequency of the audible statements (older adults often lose the ability to hear high frequencies), as well as the speed and complexity of the presentation of the major statement.
A total of 1,056 participants will be enrolled in the proposed study.
Federal Register Posting