Author: Elsa Abruzzo
Unless you’ve been living under a rock or worse, have no internet access, it is clear that with respect to the “Good”—promotional practices that is—FDA has provided ample guidance to industry in order to educate us on the rights and wrongs. They have even provided examples to help us deal with some of the potential gray areas. My last blog post touched on FDA’s “Presenting Risk Information in Prescription and Drug and Medical Device Promotion” issued May 2009. Yet, this only begins to scratch the “guidance” surface. There are many more great resources from FDA, including a Division of Drug Marketing, Advertising, and Communications (DDMAC) link that whisks you off into a magical time portal of labeling and promotions industry guidances going back to 1997. This is the friendly, gentler side of FDA…right?
As for the “Bad”, FDA has made it quite clear that they have the authority to enforce the Law and dole out the proper punishments. This is evidenced by the growing number of warning letters and enforcement actions related to promotional practices. FDA’s long standing battle against off-label promotions and misleading ads has been blogged about incessantly. Recent criminal investigations that have come to bear, in some cases 8-10 years after the original infraction, include the “September 30, 2010: Novartis Pharmaceuticals Corporation to Pay $422.5 Million for Off-Label Drug Marketing” and the “November 9, 2010: Pharmaceutical Company Lawyer Charged with Obstruction and Making False Statements”. While these pieces are very interesting and educational, I will let you read them on your own time. Instead, I want to focus on an even more interesting piece of the promotional practices puzzle – how FDA wants prescribers to help police promotional practices and stop bad (Drug) ads. Here is where things could start getting “Ugly”.
In May of this year, FDA web published “Truthful Prescription Drug Advertising and Promotion (Bad Ad Program) – The Prescriber’s Role- Recognize and Report” . According to FDA’s website “FDA’s educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.
The “Bad Ad” Program is administered by the agency’s Division of Drug Marketing, Advertising, and Communications in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”
The website goes on to explain how to recognize and report “Bad Ads”. It gives examples of violations, including omissions of risks, unapproved uses, and overstating effectiveness. Moreover, although those reporting are encouraged to provide their name and contact information in case FDA needs to follow-up with them; you can “alert FDA of potential problems” via anonymous complaints. FDA even explains what happens to a complaint once it is filed. So be aware that your customers are now an extension of the FDA when it comes to policing promotional practices. I am curious to hear your thoughts on this program. Do you think it will spur companies to be more compliant? What motivates us to do more good – guidance or enforcement? Until next time be “Good” and lay low.