From Mike Myers, President, Palio (@mmyerspalio)

Ever have something just connect the dots? For me today, it was the email seen on the left here from Lady Irina Gutavo. She’s a Russian citizen dying from cancer. While quite tragic, she has decided to donate 20 million pounds to me so that I can open a charity for the less privileged.

As a friend of mine likes to say, I may have fallen off a turnip truck but I didn’t do it yesterday – i.e. I may be an idiot but I’m not as dumb as you think Lady Irina.

Lady Irina is clearly phishing or to use pre-internet terminology – scamming me, doing the big con, false advertising, etc. And to state the obvious, they are deliberately making me this offer to ultimately take advantage of me.

Lady Irina (God bless her soul) inspired me. For the last couple of days, I’ve been trying to figure out how to tackle a blog post on the impact of warning letters that pharma brands receive from the FDA. Earlier this week, Christiane Truelove (Editor-in-chief of Med Ad News and R&D Directions – @christianetrue) and I were electronically discussing this issue after Forbes published a visually interactive list of pharma ads that crossed the line in the eyes of the FDA in one way or another. Note to all – this post was her idea.

Unlike Lady Irina and people like her, in my opinion and from personal experience, pharma brands and clients knowingly misrepresenting themselves to drive sales is a rarity. Warning letters are something that people avoid. They don’t seek them out.

While I’ve observed bad behavior a few times in the market, I’ve never seen it with my clients or on the brands that I’ve worked with. On the contrary, I’ve seen a zealous focus on doing things the right way. Beyond a basic desire to do right, all pharma brands are also highly regulated to ensure safe and appropriate use.

If I had a nickel for every client who stated that their regulatory review group was “the worst,” “the toughest,” “unreasonable,” “inconsistent,” etc. – well, I’d have a lot of nickels. And, they say it because their regulatory review groups are focused on not getting warning letters and acting like Lady Irina and her buddies.

Agencies and brand managers are also conditioned this way. FDA involvement = bad. Marketing communications that take full advantage of a brand’s label = good. Doing anything outside the rules is not acceptable.

“Full advantage” now that’s the gray area. Every brand marketer and agency out there wants to be able to say everything that they can about a product or service in the pharma space. But, with few exceptions, they want to say it within regulatory guidelines.

So, what happens when the big “bad” FDA comes calling when an ad or other promotional effort crosses that gray line? Ellen Hoenig-Carlson (Founding partner of AdvanceMarketWoRx and author of the popular blog Back of the Book – @ellenhoenig) sent a tweet out about the following article from Medical, Marketing & Media that highlights the current DDMAC increase in warning letters. The article amongst other things states that “in 2009, DDMAC issued 41 enforcement letters, including 28 untitled letters and 13 warning letters. That’s a big jump over 2008′s 21 letters, including 10 untitled letters and 11 warning letters.”

Ellen’s point, Christiane’s point and the MM&M article all show that violations or at least warnings are on the upswing.

So my question is why? Are people trying to play like Lady Irina and take advantage of others? Is pharma the bad guy that many believe that they are?

I don’t think so. In fact, I think that the FDA is just taking a harder stance on interpreting what is appropriate in label promotion for a brand. Regardless of why it’s happening, when a warning letter and associated negative press follows; the world does get spun upside down a bit for brand teams and agencies.

So what happens outside of the eye of the media when a violation occurs? An eye for eye is an appropriate way to look at how I’ve seen things play out behind the scenes. If a brand team, regulatory review group or agency is found to have knowingly broken “the rules,” they get fried. And frankly, they deserve it. The classic – if you play with fire – you will get burned scenario typically ensues.

As overt abuses are more the exception than the rule,a serious and intense focus on understanding what happened and why the FDA’s interpretation has generated a negative response is a more common occurrence. Warning letters create new boundaries. Once learned, the clients that I’ve worked with focus intensely on living within the newly defined rules.

I’ve been off the turnip truck long enough to know that not everyone plays this way. But, I’ve also seen the vast majority of clients and agencies take this responsibility about public health very seriously. In the pharma market, “mistakes” of this nature are rarely by design and almost always become learning moments.

Lady Irina is a sad case as she represents all that can be wrong with advertising and communications. So, I’ll ask you – are you pushing it too far? If you’re even close to considering it, answer the classic question – what would your mother say?

Side note since she didn’t tell me specifically…what do you think Lady Irina is going to give me 20 million pounds of ?

To be continued…