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?


Reader Comments (rss)

(Flattened / Threaded)

  1.  
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    Anonymous Coward, Aug 10th, 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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  2.  
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    lolz, Aug 10th, 2010 @ 6:29am

    Where?

    I draw the line in the sand.

     

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  3.  
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    Berenerd (profile), Aug 10th, 2010 @ 7:10am

    Re: Where?

    I step over that line and make my own in the pebbles...

     

    reply to this | link to this | view in thread ]

  4.  
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    Dan (profile), Aug 10th, 2010 @ 8:33am

    Prescription drug advertising

    should be abolished completely except for doctor's offices and hospitals. The whole point of the prescription system, is for your doctor to decide you need something, not a commercial.

     

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  5.  
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    Ron Rezendes (profile), Aug 10th, 2010 @ 8:39am

    Re:

    "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"."

    That's exactly where the line is drawn. However, I could see this scenario coming soon if it hasn't already: where the people giving the "bad advice" are paid by the drug companies which is surely illegal, once they get caught.

     

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  6.  
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    Stuart, Aug 10th, 2010 @ 8:47am

    Re: Prescription drug advertising

    I think prescription medication ads should be unmonitored. If someone wants to over rule their doctor because of an ad they saw while watching Big Brother. I say let them. If they did not research and then they start telling their doctor what they must have and their balls drop off I say that is a good thing. Helpful to humanity as a whole.

     

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  7.  
    identicon
    Anonymous Coward, Aug 10th, 2010 @ 10:38pm

    Re:

    Really?

    Explain to us all why scientists used complete stranger to play a game of protein folding and publish the results were people were able to do better than the algorithms they had and explain why a social network dedicated to gather medical information on all diseases is putting out information that later is found to be true by other researchers noting that the guy's doing the work are not scientists or medics just a bunch of people collecting and making sense of their own illnesses and therapies.

    I think the people would be fine, they have the tools now to collect and process the information on a global scale and catch any misleading F.

     

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  8.  
    identicon
    Anonymous Coward, Aug 10th, 2010 @ 10:49pm

    Re:

    The guy behind the social network talking about it.

    http://www.ted.com/talks/jamie_heywood_the_big_idea_my_brother_inspired.html

    The website.
    http://www.patientslikeme.com/

    Protein folding game.
    http://fold.it/portal/

    http://www.newscientist.com/article/mg20727725.100-computer-gamers- crack-proteinfolding-puzzle.html

    The research done by scientists has named the players as co-authors of the paper, many of them are not scientists, but have one thing that all humans share, the ability to identify patterns.

     

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  9.  
    identicon
    Anonymous Coward, Aug 10th, 2010 @ 10:52pm

    I will trust the mechanics to solve that problem

    http://www.patientslikeme.com/

    Thousands of them, with the same problem as you reporting how they feel, what they feel and aggregating that data could just make big pharma regret all the propaganda.

     

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  10.  
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    AG Wright (profile), Aug 11th, 2010 @ 4:53am

    Difference between flacks share and user share

    Perhaps the difference is that when a person that uses a drug or service and a paid flack.
    The flack has no particular expertise other than a job at a drug company. It's advertising driving the drug company. Not science or even testimonial, which we all know can be suspect.

     

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  11.  
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    lrobbo (profile), Jun 12th, 2012 @ 11:29am

    Suspect to say the least.

     

    reply to this | link to this | view in thread ]


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