The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has conducted randomized studies to measure health care provider and consumer perception of tv and print ads for hypothetical prescription drugs. The study results are now available on the FDA website.
FDA’s Bad Ad Program currently allows health care providers and consumers to report false or misleading prescription drug promotion directly to FDA. In order to comprehend the degree to which health care providers and consumers can identify false advertising, OPDP researchers created mock pharmaceutical websites that contained efficacy and risk information about two fictitious drugs. The researchers conducted a randomized study to measure the ability of primary care physicians and consumers to detect, and their tendency to report deceptive prescription drug promotion. Based on their findings, "the researchers suggested that FDA could consider, as a part of the Bad Ad Program, to solicit user-friendly consumer reporting and implement public awareness campaigns targeted to both consumers and physicians and that taking these steps could facilitate the reporting of deceptive advertising to FDA."
According to OPDP, the study's objectives included assessing "whether exaggerated efficacy images can mislead individuals, and whether providing more accurate quantitative information can reduce these misperceptions." The study included more than 1,800 participants (60 years and older) who viewed fictitious drug ads via the internet. Individuals were randomly assigned to view drug ads and respond to questions about the content of the ads. The ads either contained no images, contained accurate images of drug efficacy, or contained exaggerated images of drug efficacy. In addition, the presentation of quantitative information about drug benefits was either present or absent.
OPDP researchers had also recently created a large pool of candidate questionnaire items, that included perceived risk, perceived efficacy, perceived benefit, and risk/benefit tradeoff. Categories of risk included those "related to likelihood, magnitude, the onset of risk or beneficial effect, or duration of risk or beneficial effect." The researchers created a set of print and TV advertisements for hypothetical prescription drugs for evaluation. Participant responses were analyzed by the researchers to identify the most meaningful questions based on measures of validity and reliability.
The study results supported visual persuasion theory and concluded that "exaggerating benefits can mislead viewers". "The researchers concluded that drug companies who create drug advertisements, as well as regulators who are responsible for reviewing promotional material, should pay special attention to ensuring that images accurately reflect drug efficacy. Additionally, prescribers should ensure that patients properly understand the efficacy of a drug when considering treatment options."
A link to the FDA Website is available here.
For more information regarding OPDP research, please see the OPDP Promotional Violations section of the Enforcement Actions Database.
