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Introducing: Enforcement Action of the Month Club

Updated: Feb 2, 2018


When you’re a hammer everything looks like a:

A. Coconut

B. Marshmallow

C. Nail

D. None of the above, because hammers don’t have eyes.


Well, what is the answer anyway? The reasonable answer (depending on how much you like or dislike marshmallows or coconuts)? The metaphorically expected answer? The factually true answer? Does it even matter? It most certainly does matter. Ahhh…thinking hurts.


Creative marketing and advertising relies on its ability employ humor, art, emotion, hyperbole, metaphors, and fantasy to make a product or service attractive, memorable, and necessary or desirable. However, as we all know, prescription drug advertising is undeniably more bound to the literal truth of the product. Therefore, it is less able to employ traditional creativity. In drug advertising and marketing, cleverness and hyperbole are treated as the enemy of truth, facts, and scientific evidence. And, you know what? That’s probably the right approach.


The End of Enforcement?

So, getting back to the hammer….Our dearly beloved regulatory agencies and their enforcement divisions play an important role in public health and business. FDA’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) of FDA’s biologics center are the metaphorical hammer, keeping the American medical community and consumers safe from unsubstantiated or false or misleading advertising and promotion. However, in the past few years, enforcement is occurring at historically low frequencies. There may be many reasons for this.


There are, undeniably, anti-regulatory sentiments and directions coming from the executive branch of the government (POTUS). There are also significant First Amendment obstacles challenging FDA to re-strategize how it exerts its authority. Another reason that I believe that there is a lower frequency of enforcement, is that there is a much greater competence in regulatory affairs and compliance than in years past among the drug marketers and manufacturers. Self-regulation is much more effective today than it was in the 80’s or 90’s. I’ve seen it with my own eyes.


Nonetheless, if you believe that the age of enforcement is behind us, I have swampland in Florida to sell you. You can build your retirement home there and live to 120 if you take Himalayan green tea extract supplements specially formulated by 300-year-old demigods. These little helpers will protect you from cancer, diabetes, heart disease, and neurodegenerative conditions. I can sell you the supplements too. Cash only.


All kidding aside, in spite of the challenges to enforcement, there are still many factors for an active enforcement environment. First among these factors is that the laws and regulations prohibiting off-label promotion and false and misleading promotion have not changed substantially. Moreover, prescription drug and biologic manufacturers remain in the political crosshairs of both major US political parties for multiple reasons, chief among them, cost. When a substantial portion of the trillions of dollars in taxpayer-funded healthcare continues to go to high-cost, high-profit medicines, scrutiny will be focused on their marketing and sales practices. In addition, there are still a lot of smart people at our regulatory agencies, watchdog groups, and in the plaintiffs' bar to keep you up at night. Of course the political cycles are just that, “cycles,” and they turn and turn and continue to turn.


So, if we can’t see a lot of insight from OPDP these days due to a lack of enforcement actions, we can continue to look at past enforcement and examine its relevance to what we do today—and what we may face tomorrow. That’s why I’m introducing the Enforcement Action of the Month Club (or EAMC pronounced “EEEEMKH”). For this column I will be highlighting at least one historical enforcement action per month and hopefully impart some important insight into potential enforcement issues relevant to your work today.


Our first installment is for January 2018. Please feel free to comment or provide feedback on any of this content. I hope you find it useful.

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