Digital Pharma: Novartis rebuked for “false and misleading” websites
pharmafile | May 7, 2010 | News story | Medical Communications | disease awareness campaigns
The FDA has issued Novartis with a stern warning over two websites it sponsors, saying it considers gistalliance.com and cmlalliance.com “false and misleading”.
The regulator also wants answers from the company over its involvement with, and control of, bloodleveltesting.com which it said may violate US laws.
Following receipt of a warning letter from the FDA all three websites now default to screens saying they’re “temporarily unavailable”.
Gistalliance.com and cmlalliance.com prompted most concern at the FDA, which said it considered them branded promotional material for Novartis’ cancer drug Gleevec (imatinib) even though they were designed not to feature the product’s name.
In a warning letter to Novartis Oncology dated 21 April the FDA said: “They promote the drug for an unapproved use, fail to disclose the risks associated with the use of Gleevec and make unsubstantiated dosing claims.”
The dosing claims in particular caught the US regulator’s eye because they could “put patients at higher risk of experiencing serious adverse events”.
Novartis was told to take down the offending materials, list any of its other sites that breach the same rules and formulate a plan to issue “truthful, non-misleading, and complete corrective messages” to the two sites’ audiences.
The FDA also criticised the pharma company for not following rules for submitting advertising material for clearance before it was used.
Novartis’ drug, known as Glivec in Europe, is approved to treat certain forms of chronicmyeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
The company’s non-US CML Alliance website for healthcare professionals remains online, as does its Australian site for patients and the medical profession.
Non-branded, branded messages
In the US gistalliance.com and cmlalliance.com were considered to promote Gleevec for GIST and CML even though they didn’t mention the drug by name.
Outlining its reasoning for this the FDA said the sites:
• Discuss the use of tyrosine kinase inhibitors (TKIs) for first-line GIST and CML treatment, often in conjunction with the Novartis name, and Gleevec is the only drug of its type with these indications
• Refer to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, which recommend the use of Gleevec exclusively for the first-line treatment of CML and GIST
• Are “perceptually similar” to the Gleevec product website, using similar colour schemes (including a distinct orange) and other design elements
• Are clearly marked with the Novartis Oncology name and logo and/or the Novartis name and logo and discuss sponsorship by Novartis Pharmaceuticals Corporation
• Directly link a page for healthcare professional on the CML Alliance website to the Gleevec product website, while a page for consumers links to the Novartis-sponsored “My CML Circle Program” website, which discusses Gleevec as a treatment for CML
• Are registered to Novartis AG
• Present data from imatinib clinical studies, corresponding literature references for which include the drug name in the publication titles. At least one of the publications recounts the pivotal clinical trial submitted to FDA in support of the approval of Gleevec in an – as yet unlicensed – indication for adjuvant GIST.
“Based on this combination of factors, these websites are product specific promotions for the drug Gleevec. Consequently, these websites are subject to regulation by FDA,” the regulator said.
Disease awareness compliance
The case appears a reasonably extreme one, but nonetheless the FDA ruling is likely to prompt a swift compliance check at US pharma companies, the majority of which run numerous disease awareness websites for a wide range of conditions.
This process may well begin at Bristol-Myers Squibb, which last year launched the disease awareness website MyCMLCare.com.
The site contains information on CML treatments, along with recommended treatment goals, symptoms, tests and side effects and is aimed at carers and families as well as CML patients.
BMS’ treatment for CML Sprycel has orphan status in the US and Europe and is the first effective option for the disease in patients who can’t take current gold standard Novartis’ Glivec.
Dominic Tyer is web editor for Pharmafocus and InPharm.com and the author of the Digital Pharma blog He can be contacted via email, Twitter or LinkedIn.
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