New DTC Study Examining ‘Adequate Provision’ for Non-Web Users
FDA has announced new research to be conducted on direct-to-consumer (DTC) ads — “Utilization of Adequate Provision Among Low to Non-Internet Users.” Agency regulations require that broadcast advertisements contain a brief summary of side effects and contraindications or that “adequate provision” be made for dissemination of the approved package labeling in connection with the broadcast. This is usually fulfilled when a firm gives consumers the option of obtaining FDA-required labeling or other information through a toll-free telephone number, print advertisements or product brochures, information disseminated at health care provider offices or pharmacies, and through the Internet.
FDA says the new research’s primary purpose will be to examine the ability and willingness of low to non-Internet users to utilize the various components of adequate provision, particularly the toll-free number and print ad components. “We will also investigate the ability and willingness of low to non-Internet users to make use of Internet resources if other options were unavailable,” an agency notice says. “In addition, building on concurrent FDA research regarding drug risk information, we will assess risk perceptions as influenced by opening statements that could be used to introduce risks in DTC prescription drug broadcast ads. Opening statements may be used to frame risk information that follows. As such, consumers may interpret the likelihood, magnitude, and duration of risks differently depending on how those risks are introduced.”
Meanwhile, a new post from FDA commissioner Scott Gottlieb highlights recent research on how drug risks are presented in TV ads which suggested a more targeted presentation of risks may lead to better retention of the potential side effects that consumers should weigh as they consider their treatment decisions. “As a result, we’ve been exploring new guidelines that would recommend more focused disclosure of risk information in TV ads, to better emphasize potential side effects that are severe, serious and actionable,” he said. “I’m committed to continuing to invest in this critical research to help ensure we’re making informed, science-based decisions.”
Additionally, FDA has outlined upcoming proposed research studies under CDER’s Office of Prescription Drug Promotion’s social science research program, which provides scientific evidence to help ensure that the agency’s policies related to prescription drug promotion will have the greatest benefit to public health. One study will investigate the impact of information context, information quality, and presentation of FDA approval status in healthcare professional prescription drug promotion. “We will test promotional (sales aid) and non-promotional (journal) sources to examine the potential differences in perception that may arise by presenting the same information in different contexts,” the agency says.
Another planned study will test the effects of similarity, positioning, and timing of disease awareness ads on consumer perception and understanding of DTC product ads. And yet another study will evaluate healthcare professional opinions, attitudes, beliefs, and intentions regarding pharmaceutical promotion directed at them.