In prior post, “Bad Ads, Beware!,” we queried if we should expect to see a rise in Bad Ad complaints. It looks like the answer to our query may be “yes.” On May 5, 2011, DDMAC issued an Untitled Letter to Warner Chilcott (US), LLC, resulting from a complaint submitted to the DDMAC Bad Ad program. The complaint was made to FDA in response to a video posted on YouTube by members of the Warner Chilcott sales force. According to the DDMAC Untitled Letter, the YouTube video was approximately 60-seconds long and included a sales representative describing the product and presenting claims about the drug’s dosing benefits to a staff member in a physician’s office. The video did not include any risk information related to the use of the drug. The video allegedly was also not submitted to FDA under cover of Form FDA-2253 at the time of initial dissemination of the video.
As life sciences companies navigate how to comply with FDA regulations when formally promoting their products using digital technology and social networking websites, it looks like now they may also need to address the “informal” activities of their sales teams and other employees to avoid scrutiny. Is YouTube, and even Facebook and LinkedIn, becoming the digital version of “Homemade Bread?” How far do companies need to go to monitor and regulate their employees’ personal use of social networking websites?
This Untitled Letter reflects FDA’s continuing commitment to address social media communications and its expectation that life science companies get ahead of these issues and address their employees’ activities both in and out of the office, and online. With large sales teams and global employees, maintaining control in this area may be difficult. Perhaps now is the time to beef up the external communications policies, the disciplinary policies and the training for company employees in an effort to reduce the risk of an untitled letter or worse.
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