Seems I have a lot of questions this month! I mean to say, a lot of my recent posts have questions as titles. Why do I do that?

Anyway, this question has to do with the effect — or lack thereof — of FDA warning letters on pharmaceutical companies and product managers.

The question arose in an offline discussion I recently had with a product manager in response to my recent post entitled “YouPharma(tm): A Brave New World of Marketing?” (see what I mean about questions?).

In that post, I challenged the pharmaceutical industry to engage their customers and consumers through Web 2.0 and other technologies. BTW, if you are interested in this topic, I am doing a live podcast tomorrow at 1 PM Eastern time on that subject (see “Web 2.0 for Pharma Marketing“). I will be interviewing a couple of interesting experts and taking calls from listeners. Hope you listen in. Otherwise, download the audio afterward.

Anyway, the product manager — let’s call him Matt — had this to say:

“Enjoyed your point of view on this, as usual. I wonder, however, if the problem isn’t a lack of creative marketing managers and directors, but rather a reluctance to be the newest “test case” for DOJ or to receive a warning letter from the FDA. As someone who did inline marketing briefly at a medium sized biotech company, I can say that there was reluctance to do anything outside the box….not because we were fearful of the lack of ROI….but because it was something that no one else had done…and as such, the FDA hadn’t issued a guidance about it.

“Of course, in the big pharma world that might not be the case. Simply doing another integrated print, tv, sales aid campaign around this trimesters key messages may just be easier.

“Would love to hear your thoughts.”

As the cartoon says, “Never, ever, think outside the box.” BTW, I hope the New Yorker copyright police don’t come after me. I wanted to license this cartoon but could not for the life of me figure out what the fee was for use in blogs. they don’t have a category for that!

Anyway, I have written on the inability of pharmaceutical marketers to think outside the box before. See, for example, “Out-of-the-Box Marketing: Will It Work for Pharma?” (Another question!) In that article, I am being polite, but I thought I’d take off the gloves when responding to Matt:

“Thanks for your comments. [See how polite I am?]

“DOJ is only going to go after criminal activity — that’s a pretty bright line. I wouldn’t worry about that if you are legitimately experimenting with Web 2.0 technology.

“You might have an issue with the FTC, except that FTC has bowed out and left Rx advertising to the FDA to regulate (see “If FDA were as Powerful as FTC“).

“Warning letters from the FDA? Who’s really afraid of that “big bad wolf”? C’mon, be real! Have you ever heard of a product manager being fired because
the CEO received a warning letter from the FDA? They probably discussed it over a friendly round of golf or maybe skiing in Vale (if the PM achieved the numbers).

“Seriously. There is a right way and a wrong way to use the Internet for marketing, whether it’s Web 2.0 or 1.0.

“I have noticed that pharmaceutical marketers are lemmings of a sort — they only follow the herd. That usually means they do whatever Pfizer does. If Pfizer doesn’t do it, neither will we.

“I think this reluctance to “think outside the box” has more to do with fear of failure career-wise than fear of FDA guidance. No PM would admit that, so they create an FDA monster, when, in fact, the FDA is a pussy cat!

“Anyway, that’s my story and I’m stinking to it!”

My point is that FDA warning letters is really a bogeyman — more scary than a real threat. However, Matt suggested that the threat could be real for some companies and some managers:

“Good points, as usual. [Matt’s too kind!]

“I would argue though, that the tolerance for warning letters varies company by company — depending on what else is going on inside the company, it’s other products/divisions, and regulatory bodies. Pfizer probably doesn’t blink. There are some companies in which, a warning letter from the FDA would be a career limiting move — especially at the manager level…of course, I don’t know many companies where the manager gets to make the final decision on campaigns without regulatory and legal input.

“I agree with your points with respect to large visible failures and especially with big pharma companies. No one wants to be the guy on the brand that had a marketing campaign that failed miserably.

Fair enough. But when I talk of the pharmaceutical industry, I am thinking of the big boys like Pfizer, GSK, and Merck. If they don’t blink in a staring contest with FDA, then they need to lead the pack of lemmings along the Web 2.0 road. I am happy to see, therefore, that Merck at least has paid some lip service to more use of the Web and Pfizer announced sales force reductions (see “Out with the Bad, In with the Good“).

Let’s Hear from Product Managers
It’s easy for me to take pot shots at product managers. They are sooo quiet! I’d like to get some feedback from you guys on this topic. Even though I know a lot of you read this blog and maybe even submit anonymous comments — which I appreciate — you do not have a forum of your own like those sales reps over at CafePharma.

Therefore, I’d like to invite all pharmaceutical product managers to visit the new web-based (almost Web 2.0-based) Pharma Marketing Network Forums where I have just set up a forum just for pharma product managers called “Product Manager Corner.” Sign up under a pseudonym and vent away without fear of your bosses or regulatory folks discovering who you are! It’s an unmoderated forum, but you have to be polite like Matt 😉