Novartis warned by FDA for Tasigna promotion on Facebook

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Social media like Facebook and Twitter are the favorite places for most of the people and companies to share the information. Over two billion pieces of content are shared each week through Facebook.  Taking advantage of this huge platform, some pharmaceutical companies are promoting their drugs that misguide and mislead the patients, as per the FDA.  The FDA Division of Drug Marketing, Advertising and Communications, has recently warned Novartis for 4 different violations, in which they used Facebook to advertise Tasigna (cancer fighting medication) to potential consumers.

FDA warning to Novartis
The FDA has sent a letter to drug maker Novartis Pharmaceuticals on July 29 that tells the company that its use of Facebook Share to promote Tasigna is incomplete and misleading. The shared content is misleading because:

Failure to share risk related information- Drug description highlights the efficacy of Tasigna, but fails to communicate any risk information associated with the use of this drug. Tasigna is associated with a number of serious risks including QT prolongation and sudden deaths, severe myelosuppression, elevated serum lipase, liver function abnormalities, electrolyte abnormalities, hepatic impairment, and use in pregnancy.

Broadening of Indication- The shared content includes a very brief statement about what Tasigna treats “Tasigna (nilotinib) is used to treat a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)”.  According to FDA, these statements of Tasigna’s indication are incomplete, and misleadingly imply that the drug is approved to treat all individuals with Ph+ CML, when this is not the case.

Unsubstantiated Superiority Claims – The shared content reveals that Tasigna is a next-generation treatment for Ph+ Chronic...



Myeloid Leukemia in adult patients who are resistant to Gleevec. Referring to Tasigna as a “next generation” treatment misleadingly suggests superiority over other tyrosine kinase inhibitors approved for use in the treatment of Ph+ CML, when this superiority has not been demonstrated by substantial evidence or substantial clinical experience.

Failure to Submit-  FDA regulations require companies to submit specimens of any labeling or advertising material for promotion of a drug at least 30 days prior to the intended time of initial dissemination.  FDA says that the materials posted on facebook were not submitted to FDA 30 days prior to the intended time of initial dissemination or initial publication.

Besides the case of Tasigna, the FDA also mentioned in the letters posted on its website this week that Novartis used a misleading brochure for its blood-pressure drug Exforge; and AstraZeneca PLC (AZN, AZN.LN) used misleading promotional material for the antipsychotic.

Social media sites, such as Twitter and Facebook have become attractive routes for businesses, who wish to promote their products. I believe most of the companies have been successful as well. But using this platform to mislead the public is a sensitive issue.  Due to the regulations which exist in most countries regarding proper presentation of risks and benefits for prescription medications, drug companies should use social media carefully.

Source: businessweek

 

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