How to Avoid FDA Regulations Using Mobile Marketing

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Based on my title, you’re reading this for one of three reasons:

  1. You sincerely are looking to skirt DDMAC rules and need some inspiration;
  2. You follow the rules, but want to see what you’re missing;
  3. You are the FDA and want my address;

Great. You’ll all be pleased with the content here. In reality, I’m not looking for ways around DDMAC rules. It’s just too big of a risk (or is it?). In addition, I’m certainly not advocating spreading inaccurate information about your brand or stretching the truth. Rather, I’d like to show you just one way to avoid one annoying rule the FDA has set up for us healthcare marketers. Why would I do this? Well…I’m hoping if I point out enough of these gaps that the FDA is going take some action in setting out some updated and usable rules that tell us how we can use the latest digital technologies to market healthcare products.

Without these rules, you’re left with an industry that is finding it harder and harder to effectively market its products and a regulating body who has rules that are less and less in touch with reality.  This only makes both sides more agitated and frustrated, a potentially bad combination. So, I guess I’m poking the sleeping giant with a stick to see what happens. I hope when it awakes that it’s a friendly giant and it doesn’t decide to crush our collective digital marketing skulls.

Moving along.

The annoying rule I’m referring to is that pesky detail about including fair balance anytime you include both the product name and the condition it treats in any form of promotion. That slightly oversimplifies the rule, but basically that’s it. If you say “Ranexa”  and that it treats chronic angina then you’d better have some fair balance and probably the full prescribing information (free plug for my friends at CV Therapeutics).

So, here are your choices to avoid all that fair balance. You can simply do a promotion that uses the brand name and doesn’t say what it does. These “awareness” ads are fine although they almost certainly don’t do anything for anyone or actually increase the usage of your product. Alternatively, you can say that there’s a product that has multiple benefits for some disease, but you can’t say what it is. It’s kind of like your own little secret. Again, not sure of the value here.

Imagine instead if I had a way you could do both. You could say what the drug does AND show the name with no fair balance at all. Well, ladies and gentlemen, you can with the help of a little technology called the QR Code. What are these wonderful things? A semi-simple explanation from Wikipedia:

“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.”

For all the visual folks out there, this is a QR Code:

Dose of Digital QR Code

 

This QR Code points to this blog’s URL, doseofdigital.com. All you need is a phone with a QR Code reader and when you “tag”  this code (i.e., use the reader software), you’re phone’s web browser opens to this blog. Amazing, eh? (Interested in adding the reader software to your smartphone? Go here.)

Back to the task at hand, getting around FDA regulations. Here’s a pretty standard print ad featuring Boniva. Limited product messaging and about 40% of the space dedicated to fair balance fine print.

Sally Field Boniva

Now imagine that you can eliminate all that fair balance nonsense. Well, now you can. Interested?  If Roche/GSK decided that they wanted to say they had a drug to treat thinning bones and left it at that, no fair balance required. Alternatively, Sally could have said that she takes Boniva, but she’d have to leave out that inspiring quote. Either the name or what it does, but not both, you choose. So, here’s how you get both. [Try to ignore my 5-minute copy and design work.]

Revised Boniva Ad

Sally’s picture can be larger first of all. I’m assuming that’s a good thing since they’ve spent so much for her endorsement. But look, no fair balance because I say what the drug does (keeping bones strong and healthy) and I don’t mention the name…or do I? If your cell phone had a QR Code reader, you can just “tag” the code and your phone shows this (try it for yourself):

Boniva QR Code on Phone

Tah, dah! Your ad essentially can now show the drug name and what it does, but you can avoid all that pesky fine print. Heck, you even save some trees because you can avoid the page with all the patient information text as well. Right?

Okay, here’s the deal. Of course, I’m not advocating intentionally avoiding FDA regulations. Seriously. What I’m trying to point out is that without effective guidelines for digital media from the FDA, this is going to start happening. QR Code readers are only on about 5-10% of phones in the US, so most consumers would have no idea what it was. In Japan, QR Code readers are on almost 90% of phones. Combine the will and technical ability and someone is going to try this approach. Will they be in violation? Letter of the law says “no.” Spirit of the law probably says “yes.” Maybe it isn’t QR Codes, but it’s going to be some new digital technology.

This post is really addressed to the FDA. Either they set the rules now or healthcare marketers will set the rules for them. I’m sure the FDA isn’t interested in that approach. This follows on my post “FDA Isn’t Ready for Us…Stop All E-Marketing.” There I mentioned that I was crafting some guidelines on regulations for social media and digital technologies. Mobile needs to be a part of this. What I wanted to show in this post is what’s possible if no one comes forward and lays out the rules. The market will set the rules and no one is going to be happy with the result. The FDA can set rules that represent a reasonable comprise to give healthcare marketers some some leeway to try some new digital technologies like mobile and social media, but that ensure the spirit of regulations are accounted for.

So, to the FDA folks out there: are you ready to see bigger Sally Field ads with no fair balance or are you ready to act?

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16 Responses to “How to Avoid FDA Regulations Using Mobile Marketing”

  1. Brad at Pharma February 26, 2009 at 4:29 pm #

    QR Codes?! Incredible. I knew that young Japanese girls had started using these to mask their identities… but using them for pointing to Fair Balance? Brilliant!

    Now, the question is whether or not it’s a truly accessible fair balance… Time to forward this to the legal folks.

    #iwork@novartis

  2. Brad at Pharma February 26, 2009 at 11:29 am #

    QR Codes?! Incredible. I knew that young Japanese girls had started using these to mask their identities… but using them for pointing to Fair Balance? Brilliant!

    Now, the question is whether or not it’s a truly accessible fair balance… Time to forward this to the legal folks.

    #iwork@novartis

  3. Jonathan Richman February 26, 2009 at 8:40 pm #

    Brad, thanks for the comment. I’m sure this won’t count as accessible fair balance. I wasn’t thinking even to have the fair balance hidden in the QR code. Instead, eliminate the fair balance, give the indication, and mask the drug name in the QR Code. Who’s to say that’s wrong? Did you really show the drug name if it’s within the QR Code?

  4. Jonathan Richman February 26, 2009 at 3:40 pm #

    Brad, thanks for the comment. I’m sure this won’t count as accessible fair balance. I wasn’t thinking even to have the fair balance hidden in the QR code. Instead, eliminate the fair balance, give the indication, and mask the drug name in the QR Code. Who’s to say that’s wrong? Did you really show the drug name if it’s within the QR Code?

  5. Ali Kuru March 1, 2009 at 12:24 pm #

    In my opinion, there is no difference between “telling your products capability with a QR code on the print” and “telling your products capability with its name on the print”. It’s like you are telling your products name in a different language. Like you are using a half English and half Spanish print in a country where everybody speaks English as their native language, but also know little bit of Spanish.

    Since you are giving your products name anyway, and you are giving it with its benefits only, I don’t think FDA will ever approve it. Unless, the QR code you are using points an URL that has at least 40% fair balance fine print :)

    Ali Kuru’s last blog post..Kindle for students: What features should it have to get your money?

  6. Ali Kuru March 1, 2009 at 7:24 am #

    In my opinion, there is no difference between “telling your products capability with a QR code on the print” and “telling your products capability with its name on the print”. It’s like you are telling your products name in a different language. Like you are using a half English and half Spanish print in a country where everybody speaks English as their native language, but also know little bit of Spanish.

    Since you are giving your products name anyway, and you are giving it with its benefits only, I don’t think FDA will ever approve it. Unless, the QR code you are using points an URL that has at least 40% fair balance fine print :)

    Ali Kuru’s last blog post..Kindle for students: What features should it have to get your money?

  7. dean collins March 9, 2009 at 5:38 pm #

    like i’ve been saying for years QR codes are the ‘right mouse click’ for anything physical.

    ever poster, every cd, every marketing campaign should have a qr code.

    Cheers,
    Dean Collins
    http://www.Cognation.net/QR

  8. dean collins March 9, 2009 at 12:38 pm #

    like i’ve been saying for years QR codes are the ‘right mouse click’ for anything physical.

    ever poster, every cd, every marketing campaign should have a qr code.

    Cheers,
    Dean Collins
    http://www.Cognation.net/QR

  9. Scott May 13, 2009 at 2:22 am #

    This isn’t really so controversial.

    It’s no different than having an ad with an unbranded URL that directs to a brand site (except with QR is likely much less effective).

    Every pharma paid search campaign is now doing this.

  10. Scott May 12, 2009 at 10:22 pm #

    This isn’t really so controversial.

    It’s no different than having an ad with an unbranded URL that directs to a brand site (except with QR is likely much less effective).

    Every pharma paid search campaign is now doing this.

  11. Anonymous September 1, 2010 at 8:25 am #

    In the end, FDA needs some updates as you clearly said here. Anyways, I wouldn’t trust a word that the FDA has to say about approved drugs or similar issues. They have made many mistakes over the years which killed people. But you are indeed very creative and it seems that the FDA can be “fooled”, but the most important thing here is that the FDA is a corrupted insitution.

  12. eric October 13, 2010 at 9:26 pm #

    great, so for print & outdoor you can avoid legal requirements w a QR code, however, will you have to include all necessary legal info on the mobile landing environment the QR code drives to?

  13. remove Antivirus .NET March 1, 2011 at 7:13 am #

    OMG! thanks for sharing this info!!

  14. Cao December 12, 2011 at 11:28 pm #

    Great post! To start with, I really like your article. Anyone will a good sense of biz would realize the great potential of QR Codes in marketing. So here I’d like to recommend you a FREE QR Code generator online, it’s easy to use with many parameters customizable, including rotation and resolution.Isn’t that cool:)
    http://www.onbarcode.com/products/java_barcode/barcodes/qrcode.html