• by Wendy Davis  @wendyndavis, August 8, 2010

Novartis said Friday it stopped using a Facebook widget to promote the leukemia drug Tasigna after receiving a letter from the Food and Drug Administration alleging that the initiative violates federal regulations.

The FDA said in a letter to Novartis that its widget, which enabled users to share information about Tasigna on their Facebook pages, didn't adequately alert users to the drug's risks. The move marks the first time that the FDA has issued such a letter regarding a Facebook marketing effort. The letter, dated July 29, was made public late last week.

Novartis said in a statement that the company immediately took down the widget and is in talks with the FDA in order "to understand fully all of the concerns." The company added: "We also will assess all of our Web assets and materials based on these concerns."

The widget allowed Facebook users to post brief Novartis-created blurbs about Tasigna to their news feeds that touted the drug as a potential treatment for leukemia. One such blurb allegedly read: "In addition to taking Tasigna (nilotinib) 200-mg capsules, talking to your doctor and receiving health tips can help you treat your CML [chronic myeloid leukemia]."

The FDA said in its letter that this type of statement "misleadingly suggests that Tasigna is safer than has been demonstrated by substantial evidence or substantial clinical experience."

Although the material contained a link to a site with more detailed information, the FDA said that the link was "insufficient to mitigate the misleading omission of risk information from these promotional materials."

The letter comes as the FDA is increasingly cracking down on online advertising of pharmaceuticals. Last year, the agency told 14 large pharmaceutical companies that their search ads were misleading because the ad copy touted the benefits of drugs without also informing consumers about risks and contraindications.

Earlier this year, the consumer advocacy group Center for Digital Democracy urged the FDA to say that drug companies should not advertise in social networking platforms operated by third parties.