FDA slaps Novartis for drug Facebook page

Drug maker Novartis is in trouble with the Food and Drug Administration for creating a Facebook share widget for a cancer drug.

In a July 29 letter signed by Karen Rulli, the acting group leader for the FDA division of drug marketing, advertising and communications, Novartis gets chided for spreading what the FDA says is misleading a description of pharmaceutical drug Tasigna.

Drug advertising is subject to strict regulation over efficiency claims and risk information, but the Facebook description information generated by Facebook members "sharing" the Tasigna page "fails to communicate any risk information," Rulli wrote (emphasis in the original). Moreover, the shared Facebook Tasigna description "implies superiority over other products," she added.

Tasigna is an FDA-approved anti-leukemia drug, but for promotional material "to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug," Rulli said.

The text created by sharing the Tasigna Facebook page has included a hyperlink to a webpage containing risk information, but a hyperlink alone "is insufficient to mitigate the misleading omission of risk information," Rulli wrote.

Novartis has since edited its Facebook Tasigna page, taking down most of the content.

For More:
- download the FDA letter (.pdf)
- see the original Tasigna Facebook page (.pdf)

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