You can hardly watch television without seeing a prescription drug advertisement. Often the most memorable part of the advertisement is the required voiceover disclosing a long list of all the risks associated with taking the drug. The problem becomes deciphering which risks are actually the serious ones. FDA seeks to find out if that long disclosure of risks results in "reduced consumer comprehension, minimization of important risk information, and potentially, therapeutic noncompliance due to fear of side effects."
On February 18, 2014, FDA issued a notice seeking comments about its proposed collection of information - "Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads)." FDA proposes to investigate the impact of limiting the risk disclosure in prescription drug television advertisements to only those that are "serious and actionable" plus an alert that there are other risks associated with the drug but which are not disclosed in the advertisement.
FDA would like to hear from you by April 21, 2014 about: whether you think its investigation is necessary "for the proper performance of FDA's functions;" whether the information will have practical utility; the validity of the methodology and assumptions its investigation will use; how the quality, utility and clarity of the information collected can be enhanced; and how the collection of information can be less burdensome on respondents.
Since prescription drug advertisers are required to disclose (either audibly or audio visually) the drug's major risks in what is called the "major statement," how does FDA actually plan to investigate the issue of risk disclosure in prescription drug television advertisements? FDA asks, will it improve consumer perception and understanding of serious risks, if a prescription drug advertisement just recited the serious risks and provided an alert like "This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling."? FDA hypothesizes that it will. To test its theory, FDA will recruit over the Internet, consumers self-identified as diagnosed with one of three possible medical conditions, but excluding those working in healthcare or marketing fields. Then participants will complete a 30-minute study entailing viewing one of four randomly assigned possible advertisement versions directed at their medical condition, followed by a series of questions about the advertisement. The versions will include one with the full major statement without the additional risk alert (i.e., a version similar to existing advertisements), a second with the full major statement plus the additional risk alert, a third with an abbreviated statement of risks without the additional risk alert, and a fourth with an abbreviated statement of risk plus the additional risk alert. FDA's goals are to assess participants' perception and understanding of the drug's risks and benefits, the alert of additional risks and product quality and trust regarding product claims and the sponsor, and participants' intention to seek more information.
We will have to wait and see if FDA goes forward with this study, and if so, what, if any, changes it will bring to the lengthy, but required, risk disclosures in typical prescription drug television advertisements.