Regulatory Affairs Professional Society
By Alexander Gaffney, RAC
June 24, 2015
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.