Latest Efforts to Improve Consumer Understanding of Prescription Drug Ads

Findings from three studies conducted by the U.S. Food and Drug Administration confirm that the way information is conveyed and displayed in printed drug advertising affects consumer understanding of prescription medications. The studies, designed by experts in FDA’s Division of Drug, Marketing, Advertising and Communications (DDMAC) in the Center for Drug Evaluation and Research, examined ways to improve understanding of how consumers use the “brief summary” section of printed prescription drug ads. The online edition of the journal “Medical Decision Making” published findings from the third study today. Print ads for prescription drugs are often two (or more) pages long. The first page of the prescription drug ad may feature a picture, information about what the product is intended to be used for, and important information about the product’s risks. The second page summarizes all the product’s risks and may be presented as densely-packed text information. In the first study, a serious risk was added to the first and second page of the ad. In the second study, additional information about side effects was included on the second page. The third study tested four different brief summary formats: Traditional (block text paragraphs), Question and Answer (with headings framed in the form of questions), Highlights (based on the highlights section of the physician labeling), and Prescription Drug Facts Box (resembling the current Over the Counter Drug Facts label). Key findings of the studies include: • Adding a serious risk did not hinder people’s understanding of the risk information. • Including additional information about how often side effects occur and how long they may last did not hinder people’s understanding of the risk information. • Participants who viewed the Drug Facts format were better able to recall risks than those who saw the traditional format. A copy of “Randomized Trial of Risk Information Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs” will be available in the September/October 2011 issue of “Medical Decision Making.