Despite Few Actions On Rx Drug Promos, US FDA Increased Engagement With Stakeholders Last Year
Office of Prescription Drug Promotion issued six enforcement letters and launched three research projects in 2021. There were more internal changes as the office switched to electronic submissions of promotional materials and went through year-end reorganization.
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US FDA study is to examine the relative importance of product information, such as efficacy, risk and patient preference claims, in the treatment preferences of consumers and physicians.
US FDA study of character-space-limited prescription drug communications finds consumers may be less likely to click on a link for more risk information if the promo already has substantial details.
Promotion does not adequately communicate the diabetes drug’s indication, limits of use and risks, FDA says. It objects to distracting visuals in video and less prominent risk information. Agency had previously relayed its concerns to Lilly about Trulicity promotions.