FDA Tells Novartis That 'Facebook Sharing' Widget On Its Site Violates Drug Ad Rules

from the sharing-is-not-caring dept

Technology can certainly make for some interesting clashes with regulatory regimes. Social networking, for example, starts to bring up all sorts of questions about the fine line between certain regulated areas of advertising, and basic free speech communication issues. Eric Goldman points us to the news that the FDA is warning pharma giant Novartis (pdf) over its use of a "Facebook Share" widget on its site promoting the drug Tasigna (a leukemia drug).
The specific complaint is that the "share" feature includes promotional material about Tasigna, but not all of the associated risks (and, as with so many drugs, there's quite a list of risks). Because of the limited amount of space often used in "sharing" content, the FDA feels that some of the sharing options are misleading, not correctly noting that the drug is only approved for some users.
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.
The FDA even picks on the specific word choices in some of the sharing features, such as calling the drug a "next-generation" drug, which apparently implies it's better than other drugs in the space when that might not be the case. Advertising and marketing for pharmaceuticals has always been a contentious area, and I believe that many countries ban it, while the US allows it. But with the internet and social networking, the line between advertising and communication can start to blur. Yes, it may be problematic if Novartis is suggesting people "share" misleading or incomplete info about the drug, but what if people just start sharing that info on their own? Where do you draw the line?
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Filed Under: communications, regulations, sharing, social media
Companies: facebook, fda, novartis


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  1. identicon
    Anonymous Coward, 10 Aug 2010 @ 5:42am

    I think the line is when people start sharing on their own. At that point it goes from purposely misleading information to bad advice. Astroturfing does not count as "on their own".

    One reason is that a companies pitch is supposed to go to the world (or target group) at large (In clinical trials WONDEREX(TM) was reported to cause loss of teeth, numbness in limbs, and in some rare cases, death), while an individual's advice is based off of their own anecdotal experience (WONDEREX(TM) didn't make my teeth fall out).

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