FDA's Jean-ah Kang Says Google Black Box Ad Format is OK. But Is It "Patient-Centric?"

Jean-ah Kang, Special Assitant to the Director Tom Abrams), Office of Prescription Drug Promotion (OPDP), FDA, has "officially" said that Google's Black Box Ad Format was "OK" as long as it was one click away from the package insert (PI). She gave her blessing at FDLI's Advertising and Promotion Conference today in Washington, D.C.

First, let's look at a mockup of the ad format we are talking about:

Google's Black Box Ad Format. Click on image for an enlarged view.

"Black Box" refers to the special warning about major side effects -- often death -- that certain drug package inserts are required to display prominently in a black box. Learn more about the Black Box Warning in the Pharma Marketing Glossary (here).

Recall that Google presented this format to the FDA at the November, 2009 public hearings (see here) and at least one pharma company -- Bayer -- actually ran an ad using this format (see here).

This format is only "OK" for reminder ads, which do not mention product benefits. Hence, in this case, a version of the "one-click rule" is sanctioned (the PI is just one click away).

There are few things I don't like about this format.

First of all, it's a reminder ad, which was banned by PhRMA on TV, but for some reason not on billboards or the Internet (see "More Reminder Ad Sightings"). PhRMA's Direct-to-Consumer Advertising Guidelines state:

"DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised."

Presumably this was for the good of public health to which both PhRMA and the FDA constantly pay homage to. Except when it comes to Internet advertising. Then it's OK. That bothers me.

Another thing that bothers me is that smart Search Engine Marketing (SEM) gear heads know how to make sure these sponsored reminder ads -- for drugs with dangerous side effects (That's why they have a black box waring) -- appear in close proximity to other ads (paid or organic) that talk about the medical condition for which the drug in the reminder ad is approved.

This is illustrated in the above example where the ZINAXA (a made up treatment for depression) sponsored reminder ad appears above organic search results that clearly link ZINAXA and depression. The user can hardly miss the connection. Google doesn't even bother to hide this in the example it created for FDA to review.

In effect, the totality of the sponsored reminder ad and the organic search results tell the user that this drug is for treating depression. And it does this WITHOUT there being any mention of major side effects. And FDA is OK with this as long as the side effects are "one click away."

I doubt that this is patient-centric -- an ideal PhRMA has said FDA should embrace: "The Final Guidance should take a patient-centric approach that permits manufacturers to utilize Twitter, sponsored links and other character-limited platforms in order to convey important public health information."

P.S. Although I think SEM gear heads are smart, it could happen that these sponsored reminder ads may also appear next to lawyers' ads promoting class action law suits against these dangerous drugs.