12 March 2018 | By
To better inform its regulation of biopharma advertising and promotion, the US Food and Drug Administration (FDA) has laid out plans for upcoming research.
In a sneak peek, the agency said Monday that it’s looking into several issues, including how physicians perceive risk information for newly promoted prescription drugs, how advertising claims made in scientific publications compare with claims in promotional articles, examining the impact of ads on disease awareness vs. product promotion and how consumers understand the accelerated approval process.
In addition, FDA said it is conducting a major survey on what health care professionals think about pharmaceutical promotions directed at them.
FDA Commissioner Scott Gottlieb said in a statement: “Most recently, our research on how drug risks are presented in TV ads suggested that 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.”
The agency is also considering whether the addition of a toll-free number and print ad can help to supplement direct-to-consumer (DTC) prescription drug broadcast ads, and whether they may provide special value to consumers who are low to non-internet users.
“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,” FDA said.