DDMAC Mis-steps Badly and “Sows Confusion”

J0315598 Last week, the New York Times carried an article "FDA Rules on Ads Sow Confusion as Applied to the Web" that addresses the call by the agency to issue 14 letters regarding 45 brands based on the lack of risk information contained in search engine paid ad.  The division (DDMAC) appears to think they these actions were consistent with existing regulatory principles.  No one seems to agree.  

It is certainly not DDMAC's role or mission to "Sow Confusion" – yet it has taken actions aimed at just that outcome.  In a podcast with Eye on FDA published on March 17, DDMAC made statements that "it is the message, not the medium" and that the division would be treating the Internet like any other medium – regulating by principle.  A few weeks later, with the issuance of the 14 letters, the division acted in an about-faced manner that smacked more of regulation by whimsy than principle.  A request for them to expand upon their earlier statement in a subsequent podcast to explain the reasoning behind the 14 letters and to provide clarification, was turned down.  But the division and the FDA need to be accountable to someone – as the New York Times article clearly demonstrates.

For example, the FDA needs to clarify with specificity - 

  • How is a search engine paid ad with a link to risk information any different from a print journal ad where you have to turn a page to get risk information?  To pretend that there is a difference flies in the face of the FDA earlier stated position that it is the medium, not the message, when they are in fact, treating these two different media quite inconsistently.
  • Why did the FDA wait for years to regulate these ads?  They have been around for a long time. Either DDMAC was laying down on the job for many many years or they suddenly wanted to play whack a mole and show enforcement muscle.  Or perhaps,  DDMAC only just discovered the Internet.  What was the motivation to suddenly act? 
  • In the wake of sowing such confusion, why can't DDMAC put together a guidance process for the Internet to explain its stance on the many nuances offered by the Internet that do not exist in print or broadcast.  Yet, DDMAC and FDA have enunciated different rules on the presentation of risk information for print from broadcast.  The division did not leave it to companies to have to guess their position on it – why is DDMAC making companies guess now about nuances of the Internet.  For example, what is the FDA's position on negotiating entries on Wikipedia and Medpedia.  Why can't the agency provide its guidance on these important issues?

In the absence of any effort by DDMAC to inform, it is incumbent on the new leadership at FDA to take a hand in making sure that the division ceases sowing confusion, and instead, enunciates policy in a responsible fashion, not by caprice.  Barring that, as Arnold Fried, counsel at McDermott, Will & Emery recently said, "the affected community, including the pharmaceutical, advertising and internet industries, should organize themselves to develop and submit a principles response to FDA on the subject."  

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
This entry was posted in DTC Advertising, FDA Policy. Bookmark the permalink.

4 Responses to DDMAC Mis-steps Badly and “Sows Confusion”

Comments are closed.