Friday, May 25, 2012

Is There a Doctor in the House? FDA Bad Ad Program is Designed for You. Not So Much for Me!

Two days ago, I sent an email to FDA's "Bad Ad" program (email addr: BadAd@fda.hhs.gov) to cite a Pfizer iPhone App as a "Bad Ad" (see "Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?" for background). For the record, here's a screen shot of the email I sent (click on it for an enlarged view):


A minute later, I received an acknowledgement email from the FDA that started with "Thank you for taking the time to alert us to potentially misleading promotion," but ended with "If you are not a healthcare provider, please refer to the OPDP website for instructions on how to submit a complaint, or call (301) 796-1200." I was confused, so I called the number and left a message.

Today, Olga Salis, OPDP Senior Project Manager, called me back to explain the Bad Ad complaint process. It appears that "healthcare professionals" (i.e., mostly physicians) can submit complaints about ads via email whereas ordinary citizens such as myself MUST use snail mail; i.e., send a physical letter to FDA/CDER/OPDP, 5901-B Ammendale Rd, Beltsville, MD 20705-1266. This distinction is not clear from the information provided on the Bad Ad page here.

It's OBVIOUS that the FDA does not want to be bothered or flooded by consumer complaints because it is not making it easy for consumers to submit complaints. Who knows if FDA would have done anything with my complaint had I not called. As it is, it may take OPDP THREE months to respond or take action on my complaint, "if it has merit."

NOTE: FDA receives complaints from three sources: Healthcare Professionals (HCPs), Consumers, and "representatives of regulated industry" (ie, pharma companies ratting out their competitors). The "pharma" group of complaints was the most credible -- 58% of those complaints were deemed worthy for "comprehensive review," whereas 46% of HCP complaints and only 21% of consumer complaints made the cut (see figure below and also here):


I will followup with a written letter sent to OPDP. However, I encourage any healthcare professional reading this blog to download the Pfizer iPhone app in question and if you agree with me that it is worthy of a "bad ad" complaint to the FDA, then all you have to do is send an email to BadAd@fda.hhs.gov. Easy for you, not so  much for me :-(

2 comments:

  1. curiously that app is no longer available in the app store, could it have been a consequence of your posts, if so, who needs Bad Ads??? (says a physician...)

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    1. Oh Snap! I wasted $3.40 sending my complaint to the FDA via Certified Mail! Now they really are going to think I'm a nut!

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