Life Science Compliance Update

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April 03, 2018

FDA Plans to Review Promotional Research

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According to new releases from the FDA, it plans to look at several issues related to biopharma advertising and promotion. FDA is considering how physicians perceive risk information for newly promoted medications, how advertising claims made in scientific publications compare with claims in promotional articles, examining the impact of ads on disease awareness vs. product promotion, how consumers understand the accelerated approval process, and what health care professionals think about pharmaceutical promotions directed at them.

FDA Research

"The FDA has prioritized a robust social and behavioral science research program to help us understand how people make decisions about the products we regulate. This includes research surrounding how patients and health care providers understand prescription drug benefit and risk information in promotional materials. This research has provided key information to inform our policies related to the proper regulation of prescription drug advertising,” said FDA Commissioner Scott Gottlieb, M.D.

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.

This group is of particular interest to the FDA because certain segments of the U.S. population are unlikely to use the internet. “For example, percent of individuals aged 65 and older do not use the internet, yet are the largest consumers of prescription drugs.” As a comment provided to the FDA stated, there are individuals in this demographic who rely on others to obtain drug information, but  this perspective does not take into account the desire for privacy in obtaining such information, or the availability of these other individuals. The proposed research will provide empirical assessment of how vulnerable populations such as older adults may be impacted by changes to regulatory policy.

“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.

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