Lilly Resolves US FDA Concerns About Emgality TV Ads That Were Not Meant To Run Solo
With the Winter Games approaching, case offers lesson for companies with complex advertising packages. Lilly told the agency two commercials featuring Olympic and Paralympic athletes were intended to run sequentially with another ad including indication and risk information.
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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.
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.
Only one of the six Olympic athletes promoting Lilly’s drugs actually took the product themselves or had a family member that did. Trulicity and Emgality TV ads include disclaimers while Verzenio commercial in memory of volleyball player April Ross’ mother does not.