FDA Proposes DTC Ad Study on Effects of Spousal Consultations

The FDA wants to know how a spouse may influence a partner’s perception of a direct-to-consumer drug advertisement, the second study examining a specific DTC ad scenario that the agency has announced within a week.

In this study, the agency plans to randomize asthmatic/non-asthmatic couples to view DTC ads for asthma drugs together or alone. Participants will see ads for either a low-benefit and low-risk drug or a high-benefit but high-risk drug. Couples who view together will be prompted to discuss the ad and complete separate questionnaires, while individuals viewing it alone will be asked to answer a questionnaire alone.

The study will examine factors such as memory and understanding of risk and benefit information, intention to seek more information and the influence of spousal communications on perception.

The FDA says DTC ads often are viewed in social contexts. A partner might, for example, express concern over a drug’s side effects or prompt a person to consider a drug despite the risks, the agency said in its notice yesterday.

Others disagree. While the asthmatic person viewing the ad might actually pay some attention to the message, the other individual is unlikely to give it the time of day, said Richard Meyer, a pharma marketer and author of the World of DTC Marketing blog.

A separate summer focus group on DTC ads, which Meyer conducted, found that couples don’t discuss the benefits and risks of prescription drugs they see on TV, he added. They would be more concerned with the drug’s cost and whether it would be covered by insurance, he said; such things are not included in DTC ads.

The latest study follows the FDA’s announcement of a study on how differing levels of exposure to DTC ads affect a person’s perception of a product’s risks and benefits.

These studies are likely evidence that the FDA is again building a case for mandatory prescreening of DTC ads, said John Mack, author of the Pharma Marketing Blog. The 2007 FDA Amendments Act gave the FDA power to assess new user fees to evaluate DTC ads that drugmakers submit voluntarily, but agency efforts to get a Congressional mandate that companies submit all DTC ads for screening prior to airing have failed, Mack said.

Still, greater oversight of DTC ads would be difficult task, Mack said, noting there are many nuances at play in the communications, including use of certain words, phrases, images, font sizes and placement. “It would require a great deal of micromanaging the creative process to regulate DTC ads under a new regulatory regime focused on balancing benefits and risks,” Mack said. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.