The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently posted an untitled letter to Institut Biochimique SA (IBSA) and Akrimax Pharmaceuticals, LLC (Akrimax), the U.S. agent for Tirosint. The OPDP raised concerns regarding IBSA’s Facebook page for Tirosint because it failed to provide any risk information regarding its use, even though Tirosint is associated with a number of serious risks, including a Boxed Warning related to the use of the product for the treatment of obesity or weight loss.  According to the OPDP, “[b]y omitting the most serious and frequently occurring risks associated with Tirosint, the Facebook webpage misleadingly suggests that Tirosint is safer than has been demonstrated.”  The Facebook page also omitted material information regarding Tirosint’s FDA-approved indication.

The OPDP requested that IBSA “immediately cease violating the [Food, Drug, and Cosmetic] Act” and submit a written response by March 10, 2013 regarding whether IBSA intends to comply with this request.  The OPDP also requested a list of all promotional materials and the 2253 submission date for Tirosint that contain similar issues and a plan for discontinuing use of such materials.

Although industry continues to wait for final guidance from the FDA on social media as the July 2014 deadline set by the FDA Safety and Innovation Act approaches, the OPDP continues to issue letters to industry related to social media.  Earlier this year, the OPDP issued draft guidance regarding the postmarketing submission of interactive promotional media to the FDA.

Posted by Cooley

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