Social Media Misstep Gets Novartis an FDA Action Letter

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The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the US Food and Drug Administration (FDA) has cited Novartis AG because of the use of a social media widget on its website for the leukemia drug Tasigna. The widget, called “Facebook Share”, allows users to make representations about the drug but fails to communicate any risk information associated with the drug.

In the letter issued July 29, author Karen Rulli, acting group leader of the DDMAC, also states that the use of the widget does not adequately specify Tasigna’s indication and it “implies superiority over other products.”

Novartis Tasigna and Misleading Information

The FDA also took issue with Novartis's description of Tasigna as a "next-generation" treatment in some of the Facebook-shared content. The FDA said it has previously sent written advisory comments to Novartis about the misleading implications of the phrase "next-generation" when referring to Tasigna.

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Tasigna (nilotinib) is used to treat a certain type of leukemia, called Philadelphia chromosome-positive chronic myeloid leukemia or Ph+ CML, in people whose disease could not be treated successfully with imatinib (Gleevec). The drug works by blocking the action of the abnormal protein that signals cancer cells to multiply. Tasigna carries a warning that it may cause an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death.

The use of the Facebook Share widget allows web surfers to generate links to sites that they like and share those links with their Facebook friends. In generating the link, the widget adds a short description of the drug and a link back to the Tasigna website, but fails to provide important information to the public.

Drug-makers, like many companies, are using social media tools to help promote their products and services. However, some of these methods, such as Facebook and Twitter, cannot adequately supply all of the information the public needs for a well-informed decision about a product and also comply with the FDA’s marketing regulations.

This is the first time that the FDA has issued an enforcement letter over a Facebook widget, according to a statement by an FDA spokeswoman. But the takeaway message is that “the lessons of this enforcement action apply to all social media, not just Facebook.”

A Novartis spokeswoman has said that the company “takes the letter issued by the FDA very seriously and we have addressed its concerns by taking the direct and immediate action of taking down the widget referenced by the FDA.” The company will go over all its online materials in light of the FDA’s concerns, she wrote.

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