It had to happen at some point. A drug maker recently decided to use Facebook to promote a drug, and the FDA took enforcement action.
The Food and Drug Administration isn’t famous for having teeth when it comes to enforcement, but in this instance, it’s a step forward for them against a precocious drug manufacturer who is promoting a leukemia drug, Tasigna. The manufacturer, Novartis, is advertising and promoting its product under the auspices of Facebook Share, a social media widget, on their drug website. Evidently, the FDA sent Novartis a warning letter about its actions.
Here is how the whole setup works. The Tasigna website, set up by Novartis, has the ability to share online content about their leukemia drug through a widget/gadget called Facebook Share. The user can choose to share drug information with friends through the Share widget. If a user clicks the share button, the widget program automatically sends a post (under the name of Novartis) to the user’s personal Facebook page, where it is visible to all of the user’s friends.
This post contains information about the name of the drug, its uses, a picture of it and a link to the Tasigna website. The content is created from Tasigna website metadata. This is important, because the metadata is used by search engines to mine online information, but it is not visible to the website user. Before a Facebook user posted/shared this info, he or she could add an original comment, but could not change any of the Novartis product info.
The bottom line is that the FDA sent the warning letter to Novartis, as they felt the drug company was misleading people using Facebook Share. Basically, this was all about Tasgina being misbranded under the Food, Drug and Cosmetic Act because of four violations in using Facebook Share. Those violations included the fact that Novartis didn’t outline any risk information for patients in a clear and upfront manner and that the company implied Tasigna could treat all patients with leukemia and not just a particular subset. They also found that Novartis’s statement that the drug was “Next Generation” was misleading as it implied superiority over other similar products (an unproven claim) and that Novartis didn’t comply with a mandatory call to submit labeling and advertising info to the FDA before they sent information out.
What does this all mean? It means the FDA has a particular take on using social media and Web 2.0 technology and if a drug company doesn’t want to run afoul of it, they need to put proper procedures and policies into place to make sure they’re compliant. One hopes this will ultimately protect Facebook users from the onslaught of unproven – possibly improperly tested – questionable drug company promotion of various drugs. But time will tell.