FDA Warns Novartis Over Advertising on Facebook
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The Food and Drug Administration on July 29 posted a warning letter addressed to Novartis on its website saying the drug maker's advertising of its anti-cancer drug Tasigna on Facebook is misleading.
The letter from Karen R. Rulli Ph.D., Division of Drug Marketing, Advertising and Communications lists a number of violations when Novartis promoted Tasigna on the social networking website.
Tasigna is an FDA-approved drug indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia in adult patients resistant or intolerant to prior therapy that included imatinib, according to the warning letter.
One of the major problems with Novartis's promotion on Facebook is that the advertising material does not contain the information of risks associated with Tasigna.
The adverse effects of this drug are not trivial. They include QT prolongation and sudden deaths, severe myelosuppression, increased levels of serum lipase, liver function abnormalities and impairment among other things. Patients using the drug should be monitored with multiple laboratory tests, the letter says.
In addition to the omission of risks, Novartis's advertising through Facebook Share widget also misleadingly broadened indication for Tasigna, suggested the drug is superior to other medications and overstated its efficacy.
Lastly, the letter points out that Novartis failed to comply with the FDA regulations that require companies to submit specimens of any labeling or advertising devised for promotion of an approved drug at least 30 days prior to the time of initial dissemination.
Media reports say that Novartis removed its promotional content for Tasigna from Facebook immediately after it received the warning and right now is in talks with the FDA to address the agency's concerns about its advertising practice.
This is not the first time Novartis has been warned by the FDA.
Thomas W. Abrams from the Division of Drug marketing, Advertising and Communications in April posted a warning letter addressed to Lugwig Hantson Ph.D. CEO Novartis Pharmaceuticals Corporation saying that a number of websites sponsored by the drug maker intended to promote Gleevec are false and misleading.
The FDA agent says in his letter that these websites "promote the drug for an unapproved use, fail to disclose the risks associated with the use of Gleevec and make unsubstantiated dosing claims."
It is unknown what does a warning letter mean to the recipient. At least it does not seem the letter itself would result in any immediate penalty if there is any.
Novartis may not be the only drug maker that has received warning letters.
Industry insiders and some consumers may have known that the federal agency has launched a "bad ad program" this year to encourage drug consumers and medical professionals to report any drug advertisement that is misleading.
By David Liu
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