DDMAC Mis-steps Badly and "Sows Confusion"

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."  

Comments

[John Mack]

Mark,

Thanks for pointing out that recent FDA actions have caused more questions than answers, which is more reason why the FDA needs to meet with ALL stakeholders -- not just pharma companies, but also patient groups, physicians, etc. -- to discuss these issues and learn the concerns of all involved.

I would appreciate your feedback on my draft petition to the FDA to convene such a hearing (see "FDA, Tear Down This Wall! A Draft Petition Calling for a Public Hearing" http://tinyurl.com/dgnaxv). I also invite feedback from your readers.

To help with this effort, I have also been surveying people on how the FDA should proceed to develop draft guidelines for the industry. You can find this survey here: http://bit.ly/150lsp

[ted]

Mark,
As a healthcare marketer, I am not in agreement with many DDMAC actions over the many years I've been at this. However, I must say that I sort of get where they're coming from here.
The example of a print ad and turning the page is not accurate. The Fair Balance is always on the same surface (can be a spread of pages visible without turning the page) as the logo and claim. The Brief Summary (print ad version of the PI) is different. Just as DDMAC allows the full PI to be one click away. However, the Fair Balance is another matter.
As for taking all these years to get around to letting everyone know that search ads are in violation, point taken. This is pretty standard however. Not that that makes it OK. Caprice has been a feature of enforcement for a long time now.

[Dan]

DDMAC does one good thing: They issue copious amounts of warning letters to those they are suppose to regulate. They mean nothing. It's not unusual for a drug company, for example, to receive at least one warning letter a year. They continue to demonstrate the wrongful behavior that is in the warning letter to them. Those companies who provide products to restore the health of others are allowed in essence to commit crimes first, and then be told not to anymore. Sort of a cop saying to a villian, "Stop, or...I'll stay stop again." There is no deterrent that has been activated against a medical company that has effectively modified their criminal behavior. And this may be by intentional design.