DTC Advertising

FDA Regulations on DTC Risk Information Could Be Backfiring

Oct. 16, 2017 — As the FDA considers the most effective way for pharmaceutical companies to present risks in direct-to-consumer (DTC) ads, a recently published paper in Nature Human Behavior underscores the commonly held belief that consumers do not respond well to a barrage of product risk information.

According to the paper abstract, these long lists of potential risks actually may have the opposite effect of what regulators intend. “When commercials list severe side effects along with those that are most frequent (which include both serious and minor side effects), as required by the [FDA], it dilutes consumers’ judgements of the overall severity of the side effects, compared with when only the serious side effects are listed,” the abstract states. Further, “consumers’ reduced judgement of severity leads to greater attraction to those drugs.”

“The research keeps pouring in, demonstrating what professional advertisers have long known: lengthy, complicated disclosures are counterproductive,” said Coalition for Healthcare Communication Executive Director John Kamp. “It’s time for FDA to act, to follow its own research and good public policy,” he said.  “Good advertising has short, simple messages that people can understand and act upon.”

An Oct. 10 article published in CardioBrief states that the paper’s authors, Niro Sivanathan and Hemant Kakkars wanted to study how the FDA’s regulations in this area actually may be creating a less effective way of informing consumers of the potential risk and side effects of drugs.

“Over the years, these regulated advertisements might have produced the unintended outcome of dampening one’s assessment of the side effects and in the process further promoted the benefits and attractiveness of the drugs,” the paper states. The authors attribute this to the “argument dilution effect,” in which “information of little value and consequence for outcome prediction … dilutes that value and importance” of information about more serious consequences, according to CardioBrief.

The paper abstract states that “in regulating pharmaceutical advertisements, the [FDA] appears to have paradoxically dampened consumers’ judgements of overall severity and risk, and increased the marketability of these drugs.”

An FDA-funded study released in July concluded that a revised, briefer risk statement in broadcast DTC ads improves risk and benefit recognition and risk recall. The agency opened a public docket on this issue in August (http://cohealthcom.org/2017/08/22/fda-opens-docket-on-limiting-risk-communication-in-dtc-ads/).

To view the full CardioBrief article on this paper, go to: http://www.cardiobrief.org/2017/10/10/side-effects-in-drug-ads-dont-add-up/