Novartis Facebook Tool On Tasigna Presents Misleading Drug Information, Says FDA

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Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 08 Aug 2010 - 10:00 PDT


Novartis, the drug company that makes and sells cancer drug Tasigna, has received a letter from the FDA (Food and Drug Administration), USA, which accuses it of using a Facebook tool on the website with misleading information about Tasigna (nilotinib), used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML,). Tasigna is typically prescribed for patients who cannot tolerate certain other leukemia drugs, or those who have not responded well to other medications.

The FDA letter states:

This website contains a "Facebook Share" social media widget that generates Novartis-created information for Tasigna that can be shared with Facebook users (i.e., "shared content").

The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug.

In addition, the shared content inadequately communicates Tasigna's FDA-approved indication and implies superiority over other products. Thus, the shared content for Tasigna misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations. See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 202.1(e)(3)(i), (ii) & (e)(6)(i). Furthermore, these materials were neither submitted to FDA 30 days prior to the intended time of initial dissemination or initial publication as required by 21 CFR 314.550, nor submitted to FDA on Form FDA 2253 at the time of initial dissemination or initial publication, as required by 21 CFR 314.81(b)(3)(i).

Social media sites, such as Twitter and Facebook are attractive routes for businesses who wish to promote their products. However, due to regulations which exist in most countries regarding proper presentation of risks and benefits for prescription medications, drug companies have had to tread carefully.

In the letter to Director, Regulatory Affairs - Oncology, Novartis, New Jersey, the FDA says that the information regarding FDA-approved indication is inadequate. It also states that there is a suggestion of superiority over other products.

Broadening the indication for the drug

The FDA says that in several instances, the shared content posted via the Facebook Share widget includes a very brief statement about what Tasigna treats that misleadingly broadens the indication for this drug.

Examples include:

• Home - Tasigna (nilotinib) 200 mg capsules
  www.us.tasigna.com
  
  Tasigna (nilotinib) is used to treat a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)
• Treating Your Ph+ CML with Tasigna | Tasigna (nilotinib) 200-mg capsules
  www.us.tasigna.com
  
  
  In addition to taking Tasigna (nilotinib) 200-mg capsules, talking to your doctor and receiving health tips can help you treat your CML.
• For Your Ph+ CML Patients - Tasigna (nilotinib) 200mg capsules
  http://www.us.tasigna.com
  
  More information to Support your Patients

The FDA letter says these (above) statements are incomplete and misleadingly imply that Tasigna is approved to treat all patients with Ph+ CML (not the case). When the shared content was originally disseminated Tasigna was only approved as a second-line option, after treatment with other drugs, such as imatinib either failed or the patient could not tolerate them. Furthermore, Tasigna is only approved for use in patients with Ph+ CML in the chronic or accelerated phases.

The letter also stated (referring to the three statements above in Facebook):

Moreover, the statements above broaden even the newly approved indication for Tasigna (i.e., Tasigna is still not approved to treat all individuals with Ph+ CML). This shared content also fails to disclose other important limitations to Tasigna's use; i.e., that its effectiveness is based on hematologic and cytogenetic response rates and there are no controlled trials demonstrating a clinical benefit, such as improvement in symptoms or increased survival. Therefore, it misleadingly broadens the indication for Tasigna by suggesting that it is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience.

Implied superiority over other drugs

The FDA says that Novartis refers to Tasigna as a "next generation" treatment. This is misleading and suggests superiority over other tyrosine kinase inhibitors approved for use in the treatment of Ph+ CML when this advantage has not been demonstrated by substantial evidence or substantial clinical experience. The letter adds that previous written advisory comments had been sent to Novartis about the misleading implications of the phrase "next generation" when referring to Tasigna.

Example of how Novartis presents Tasigna as a next generation treatment:

CML (Chronic Myeloid Leukemia)Treatment - Find out if Tasigna is Right for You
Tasigna (nilotinib)
www.us.tasigna.com
Tasigna (nilotinib) 200-mg capsules from Novartis is a next-generation treatment for Ph+ Chronic Myeloid Leukemia in adult patients in chronic or accelerated phase who are resistant to Gleevec.

Failure to submit

The letter states:

Although the website content was submitted to FDA pursuant to 21 CFR 314.550 and 21 CFR 314.81, the shared content was not submitted to FDA 30 days prior to the intended time of initial dissemination or initial publication as required by 21 CFR 314.550, and was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication, as required by 21 CFR 314.81(b)(3)(i).

What the FDA wants Novartis to do

The FDA asks Novartis to stop disseminating "violative promotional material" for Tasigna, such as those quoted in the letter. Novartis is also asked to respond in writing before August 12^th 2010, stating whether the company intends to comply with this request.

The letter ends with:

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Tasigna comply with each applicable requirement of the Act and FDA implementing regulations.

The letter was written by: Karen R. Rulli, Ph.D., Acting Group Leader, Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA.

Written by: Christian Nordqvist


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