FDA studies consumer perception of DTC drug ads, willingness to report false claims

Regulatory NewsRegulatory News | 20 August 2021 |  By 

The US Food and Drug Administration (FDA) is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on how to measure consumer perceptions of the information presented in ads.
In a recent Regulatory Science in Action article, the agency outlined findings from three studies looking at the role of images in advertising, the development of valid measures to assess perception of ads, and the likelihood that physicians and consumers would recognize deceptive claims and report them. These findings will help “inform guidance” and “enhance review of drug promotion,” according to the article.
In general, FDA does not approve prescription drug advertising before it is made public but the Office of Prescription Drug Promotion (OPDP) within FDA’s Center for Drug Evaluation and Research (CDER) monitors both advertisements and promotional labeling to ensure no contain false or misleading information is put forward. They also follow up on complaints made through the agency’s Bad Ad Program. (RELATED: OPDP’s Gray reflects on 2020’s challenges, successes, Regulatory Focus 25 January 2021).  
Images can mislead

In one study, led by OPDP researchers, images played an important role in how consumers perceived the effectiveness of a drug; the researchers found that exaggerated images often led to an inflated perception of the drug’s benefits.
In the randomized study, more than 1,800 individuals aged 60 years and older viewed ads for fictional drugs to treat plaque psoriasis or wet age-related macular degeneration. Participants viewed ads that either did not contain images, contained images that accurately reflected the efficacy information in the ad, or contained images that exaggerated the efficacy information presented. Additionally, the ads either described the drug’s benefits broadly or included quantitative information about the drug’s clinical benefits.
The researchers found that across both conditions, participants who saw the exaggerated images were more likely to have exaggerated perceptions about the drug’s efficacy. They also found that the inclusion of quantitative information on drug benefit improved the participants’ understanding and in some cases even counteracted the misleading images.
“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,” FDA wrote.
Measuring consumer perception

Another research effort led by FDA experimented with ways to accurately measure consumer perception of drug advertising. Researchers created 31 questionnaire items on perceived risk, 32 items on perceived efficacy, 29 items on perceived benefit, and 5 items on risk/benefit tradeoff and tested them among a panel of more than 7,500 adult consumers. The participants viewed a set of television and print advertisements for fictional drugs to treat high blood pressure or chronic pain.
The researchers performed three waves of quantitative testing on the responses and came away with 21 validated questionnaire items from an overall pool of 97. For example, one validated question asked consumers to rate on a scale of 1 (not at all likely) to 6 (extremely likely), “how likely is it that you would experience at least one side effect if you took [drug name]?”
“Reliable instruments for measuring consumer perceptions of prescription drug risk, efficacy, and benefit are essential tools for rigorously evaluating direct-to-consumer prescription drug promotion,” FDA wrote.
Detecting false claims

Finally, researchers conducted a randomized study to determine whether primary care physicians and consumers could detect deceptive prescription drug promotion information, and if they would be willing to report it. OPDP researchers built mock pharmaceutical websites with risk and benefit information for two fictional drugs. One website featured varying numbers of deceptive claims and tactics (none, two, five) about a fictional drug to treat chronic pain. The other website touted a fictional obesity drug and included either no false claims, implicitly false claims, or explicitly false claims.
Overall, both physicians and consumers were mostly able to detect deceptive claims and thought they should be reported. However, more than one-third of consumers and one-quarter of physicians who viewed five deceptive claims and tactics on the chronic pain website reported that there were no inaccuracies. Among physicians who viewed explicitly false information, half said the promotions did not have inaccuracies.
When it came to reporting misleading claims, there was some reluctance from both consumers and physicians. One-quarter of physicians and about one-third of consumers said they would not report misleading drug product advertising. FDA speculated that part of the issue could be that they didn’t know about reporting opportunities like the Bad Ad Program, which allows health care providers to report misleading or false drug promotion directly to the agency. Fewer than 10% of physicians and 4% of consumers were aware of the program, the agency said.
“Based on these 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 the FDA.”
Regulatory Science in Action: Advancing Our Understanding of How Drug Promotion Influences Consumers and Health Care Providers


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Tags: Ad, Bad, FDA, OPDP, program, promotion, US

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