OPDP Issues First Untitled Letter for Branded Facebook Page

March 14, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) on Feb. 24 issued its first enforcement letter for promotional activities occurring on Facebook, according to a Digitas Health Regulatory Alert. The March 12 Alert states that OPDP sent an Untitled Letter to Institut Biochimique SA (IBSA) for a branded Facebook page for Tirosint (levothyroxine sodium) capsules for oral use.

“This action is notable because it is the first enforcement action taken by the FDA for any social media activity since FDA issued its first social media guidance on January 13, 2014,” according to Dale Cooke, Vice President/Group Director, Regulatory Review, Digitas Health. “This also is the first time [OPDP] has issued an enforcement action for promotional activities occurring on Facebook.com, though OPDP has previously taken action for Facebook sharing activities implemented on product sites.”

The Alert states that the enforcement action was taken because the branded Tirosint Facebook page included the product name and an abbreviated statement of the product indication, but did not include any risk information.

“This enforcement action from the FDA does not itself provide additional insight into OPDP’s view of how to appropriately use social media because the violations cited were so straightforward,” Cooke stated. “It does, however, highlight the need for companies who are engaging in social media to ensure that the appropriate safe guards are in place to do so appropriately.”

To read the entire Alert, go to: http://www.scribd.com/doc/212262834/DH-Regulatory-Alert-OPDP-Issues-First-Letter-for-Facebook-Page-Activity