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Tips from the Geekery: How drug sellers can outwit the FDA PDF Print E-mail
News - Online - IPs, spam, and affiliates
Written by Erin Siegal   
Saturday, 07 March 2009 00:00

A recent post on Jonathan Richman's blog Dose of Digital opens with a snappy confrontation. The post, "How to Avoid FDA Regulations Using Mobile Marketing," begins:

Based on my title, you're reading this for one of three reasons:
  • You sincerely are looking to skirt DDMAC rules and need some inspiration;
  • You follow the rules, but want to see what you're missing;
  • You are the FDA and want my address.
  •  

    OK. Well, to lay the groundwork here, "DDMAC" stands for the FDA's Division of Drug Marketing, Advertising and Communications.

    The DDMAC's mission is:

    "To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers."

    Richman's post goes on to detail how pharmaceutical sellers can skirt the FDA regulation on fair marketing, which requires drug ads to describe in detail the conditions for which the drug can be used. (This is all the fine print that appears in drug ads). Richman has discovered a loophole that can be used by those, including online pharma, that peddle drugs on Web sites that can be accessed via mobile phones. The loophole is the (Quick Response) Code- a kind of two-dimensional bar code that allows for high speed decoding. In the US, only about 10% of phones have them. In Japan, that number is 90%. Here's what the QR code looks like:

    Image from The Sun

    According to Wikipedia, the QR Code is mainly used for mobile tagging today- that is, it's used as a commercial tracking application. Basically, if you see a piece of code- like this one- you can snap a picture with your cell phone, decode the data contained in the image, and then follow this physical world hyperlink to a certain website. Here's an example of code on a building.

     

    If a consumer has a cell phone with a QR Code reader, it'll be able to decode (or "tag") this code. This means that drug ads on mobile phones can do away with naming the drug or having to put information about it as demanded by the FDA. The mobile-phone user can simply click on the code and find out the drug's name (without having to go through the fine print). Richman's post shows how this could work via photo examples of drug ads with code and without.

    So why is he publicizing this exception to the world? The author says that he/she's "poking the sleeping giant with a stick to see what happens" because "Either they [FDA] set the rules now or healthcare marketers will set the rules for them." And just why is advertising regulation so important, you might ask? Well, for starters, it's been shown that big pharma spends more money on advertising than on research and development.

     

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    Last Updated on Friday, 20 March 2009 13:16
     

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