Tuesday, October 29, 2013

FDA's BadAd CE Program: There Should Be An App for This!

I just completed FDA's BadAd online course for healthcare professionals who can earn CE credits while learning how to identify potentially untruthful or misleading drug ads and promotional materials. The course is offered through Medscape here.

Although I don't get any CE credits -- I only pretend to be a doctor on Medscape -- I did get a nice Certificate of Completion at the end of the course (click on it for an enlarged view).

I have written about FDA's BadAd program previously (read FDA's Bad Ad Program is "Phoniest Thing Ever!", Pharmaguy Alerts FDA About BadAd Technical "Glitch", and Competitors Are "Best Source" of Complaints About Promotions Received by FDA).

I once famously said; "My impression of the BadAd program is that it was created by former drug industry sales professionals and is designed to make it easier for sales reps and company-paid physicians to 'rat out' their competitors, anonymously or not. It just doesn't present a good image of how a government agency should work."

I was right about the program being created by a former drug rep: It was the brain child of Michael Sauers, who used to be a Pfizer sales rep, and is now Deputy Director, Division of Advertising and Promotion Review II. Sauers is just one of several FDA employees featured in the course videos.

Upon completion of the course, participants are told they will be able to:
  1. Identify the role that FDA, OPDP and HCPs play in regulating prescription drug promotion and advertising 
  2. Describe the most common regulatory issues raised by prescription drug promotion 
  3. Recognize false or misleading prescription drug promotion
In my case,  the course succeeded in achieving those learning objectives.

One other objective not mentioned is that this course obviously promotes the BadAd program and emphasizes how to submit a complaint to the program several times throughout the course. Unfortunately, there are only two options for submitting a complaint: (1) by email or (2) by phone. The course even includes a video of how to submit a complaint via email!

I guess the FDA hasn't heard that practically every physician uses an iPhone and/or iPad. Why not have a convenient mobile app for reporting complaints about ads? The FDA obviously spent a ton of money on the course, but skimped on the most important part of its program -- making it easy for docs to submit complaints!

Module 5: Real-Life Scenarios was the most interesting part of the course. It included 5 scenarios in which actors played healthcare professionals subjected to various forms of drug promotion. This was probably the most expensive part of the program because it required actors, costumes, sets, etc.

I was able to correctly identify 4 out of 5 promotional issues even without reading the package insert! That's how obvious most of these scenarios were.

Module 2: The Science of Influence was also interesting because it demonstrates that the FDA buys into the "Six Principles of Influence" that I wrote about in a recent issue of Pharma Marketing News (read "Physicians Under Pharma's Influence"), although FDA says there is nothing illegal about employing these principles -- you should just be aware when they are being used by crafty sales reps and adverts.

The authors of a study I reviewed in the Pharma Marketing News article identified the six principles that are "key to the industry’s routine marketing strategies, which rely on the illusion that the industry is a generous avuncular partner to physicians":
  1. reciprocation, 
  2. commitment, 
  3. social proof, 
  4. liking, 
  5. authority, and 
  6. scarcity

Dr. Linda J. Demaine demonstrated how each scenario in Module 5 utilized one or more of these six principles. Listen to how Dr. Demaine explains how free lunches for physicians employ the "reciprocation" principle:

Well done, FDA! But, seriously, consider developing an app for this.

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