Pity the poor FDA! Despite its use of social and other "New" media, the FDA is not equipped to keep up with the new technology that allows unethical pharmaceutical marketers to get around FDA regulations relating to "fair balance," etc.
I have pointed out in the past certain "tricks" that pharmaceutical marketers can and ARE using to get around FDA regulations (see "Web 2.0 Pharma Marketing Tricks for Dummies").
Recently, the FDA DID manage to catch one of these tricksters (see "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!").
Today, thanks to ePharma Pioneer Club member Jonathan Richman, I learned a New "New Media" Trick: use of "QR Code" in mobile marketing (see "How to Avoid FDA Regulations Using Mobile Marketing").
Richman cites this wikipedia definition: “A QR Code is a matrix code (or two-dimensional bar code) created by Japanese corporation Denso-Wave in 1994. The “QR” is derived from “Quick Response”, as the creator intended the code to allow its contents to be decoded at high speed ... QR Codes are now used in a much broader context, including both commercial tracking applications and convenience-oriented applications aimed at mobile phone users (known as mobile tagging). QR Codes storing addresses and URLs may appear in magazines, on signs, buses, business cards or just about any object that users might need information about. Users with a camera phone equipped with the correct reader software can scan the image of the QR Code causing the phone’s browser to launch and redirect to the programmed URL.”
The image above/left is an example of a QR Code that points to Richman's blog.
Richman created a mock up mobile ad for Boniva using an image of Sally Field, who is quoted as saying "I use something once a month to keep my bones strong and healthy." No product is mentioned by name, but the ad also includes a QR Code that links to the boniva.com web site. All you need is a QR Code reader on your smart phone to bring up the product name and visit the Web site.
Richman says this is a way that pharma marketers can avoid including all the nasty "fair balance" that FDA requires in drug ads.
Of course, the ad itself is nothing new -- it's called a "reminder ad" and it is perfectly legal. [NOTE: There is no such Boniva reminder ad to my knowledge.] Of course, such an ad would violate the spirit of PhRMA's new guidelines for broadcast and print DTC ads. Those guidelines, however, do not apply to ads on the Internet or on mobile phones.
Richman was trying to make a point that "without effective guidelines for digital media from the FDA, this [sort of thing] is going to start happening." Maybe. But we may have to wait til hell freezes over for the FDA to develop guidelines. What we need to do is bring together stakeholders from the drug industry, consumer/patient groups, healthcare professionals, AND the government to develop ethical guidelines for use of new digital media for health advertising.
For me, this is deja vu all over again!