From Ian DeMeritt, Senior Medical Writer, Palio
In what may be the first DDMAC letter to focus on Facebook, Novartis Pharmaceuticals was just warned that its use of Share Widgets on the Tasigna (nilotinib) Web site was illegal and that it misbranded the drug. Tasigna is “indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive [Ph+] chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib.” The Tasigna PI contains a boxed warning and the FDA required a REMS program for Tasigna to educate healthcare providers and patients about proper dosing strategies to avoid serious risks.
The Tasigna Web site contained several Share Widgets. By clicking on these icons, visitors were able to quickly and easily share information about Tasigna on Facebook, Twitter, or other social media sites. A short description of Tasigna (including its indication) and a link to the Tasigna Web site would then appear on the user’s Facebook page visible for all of his or her friends to see. Although users were unable to edit the Novartis-generated text, they could include comments along with the post.
While I applaud this use of social media by Novartis, there was only one problem with this approach that anyone familiar with recent DDMAC communication in this area could predict (except, apparently, the Novartis regulatory team): no safety information was included on the Facebook pages of visitors who shared the link. Even though a link to the Tasigna Web site was present, DDMAC has made it pretty clear over the past couple of years that when it comes to social media, it doesn’t recognize a so-called “one-click rule.”
To my knowledge, this issue was first addressed by DDMAC in the 2008 untitled letter regarding banner advertisements for Diovan; this letter was also issued to none other than Novartis. That letter clearly stated the need to include safety information in on-line communications, and that a link to safety information is insufficient to communicate risk information:
“The [Diovan] banners, however, entirely omit all risk information, including the warnings, precautions, and the most frequently reported adverse events from the PI. We note that a link to the PI and Patient Product Information (PPI) is included at the bottom of the banners. However, this does not mitigate the misleading omission of risk information from the banners.”
Not surprisingly, DDMAC’s position hasn’t changed in the past 2 years. The following wording from the latest letter is nearly a direct copy-and-paste from the letter issued in 2008:
“We note that the shared content contains a hyperlink to various Tasigna product websites, which do contain risk information. However, the inclusion of such a hyperlink is insufficient to mitigate the misleading omission of risk information from these promotional materials.”
Given the previous communications between DDMAC and Novartis, I find it curious that they continue to test the “one-click rule.” Whether this latest misstep was intentional or not, it highlights the fact that the issue of pharmaceutical advertising in social media is not going away. Until DDMAC releases its guidance on social media these issues will continue to surface and DDMAC will continue to issue letters to companies who fail to comply.
Until then, I wonder if DDMAC will accept my friend request.
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