I learned a few things and collected lots of good sound bites/catch phrases relating to eDetailing (“Innovate or Die!”), Web 2.0 (“Don’t get blinded by the technology”), and adverse event reporting (“Your fear is unfounded”).
You can read about all that good stuff in an upcoming issue of Pharma Marketing News. Here, I’d like to focus on my “rant” about the so-called “one-click” rule in online pharmaceutical marketing.
“Rant” is the way John C. Serio, partner in the Boston office of Seyfarth Shaw LLP and a paisan with roots in Sicily (on his father’s side), characterized my comments about the “one-click rule.” On the left is the old school black and white photo of Serio that I found on his firm’s Web site.
Serio’s comment — “Someone wrote in and went on a rant that the one-click rule was not an FDA regulation” — was made during a panel discussion about how to overcome the regulatory hurdles to successful pharma “monitoring and marketing,” which BTW is another good catch phrase.
The panel also included Fard Johnmar (Founder, Envision Solutions) and Jim Nail (CMO, TNS Media Intelligence/Cymfony).
The panelists summarized a new social media monitoring and marketing framework for pharmaceutical companies that Fard’s and Jim’s companies collaborated on (see “New Social Media Marketing Framework White Paper“).
Rant or No Rant?
I read this white paper and had only one criticism: the “one-click rule” is no rule at all and is merely a platitude online pharmaceutical marketers spout to trick us into believing that they obey “rules.” Since I spend a lot of time documenting how pharma marketers violate this “rule” repeatedly, I thought I would write a comment to the authors of the Framework. Here it is. You decide if it is a “rant” or not.
In the paper, the authors make frequent reference to the so-called “one-click rule” regarding access to fair balance information on the Internet.
If you search Google on “one-click rule FDA” you won’t find any references to this rule that the FDA has made, but you will find my post “Girl from Google.”
That’s because, in that post, I discuss how the so-called “one-click rule” was used to justify Google Adwords (aka, “BAdwords”) that violate FDA guidelines — these ads mention the brand name and indication, but do NOT include any fair balance as is required by FDA.
One person from a pharmaceutical company, perhaps playing the devil’s advocate, contended that these “BAdword” ads may pass muster with the FDA because the package insert or brief summary is “one or two clicks away.” His argument was that without specific guidance from the FDA, no one knows what is correct in this case.
The “one click away” defense does not apply here. FDA says it’s OK on an Rx product Web site to merely provide a link to the package insert or brief summary. In that case there is no need to provide that information on the same page that mentions the drug name and its indication.
Thus, an AdWord could be said to comply with the “one click rule” only if within the AdWord text there was a direct link to the package insert (PI) or brief summary.
In “BAdwords,” there is only a link to the product Web site, not the PI. Presumably, the user would have to find the link to PI once on the product Web site.
So, if there actually is a “one-click rule,” it is not correct to invoke it for every kind of ad on the Internet, and surely not in cases where you really need TWO clicks to get to the PI or fair balance!
It is a shame that the FDA does not have any guidance for the industry as far as Internet advertising is concerned. This means that marketers can use lack of guidance as a defense for sneaking in ads that push the envelope. What are the chances that the FDA would ever notice. These ads are fleeting, here today, gone tomorrow!
I posted this in a comment to the Comfy Blog on Sep 6, 2007 1:36:37 PM
Jim Nail responded:
Agreed — there is no “official” FDA one-click rule, nor do we say there is. But there is a “received precedent” that if you have one click from your brand site to the PI or labeling information, that is acceptable. Or call it “best practice”. Or call it just “common practice”. In our paper we say that if you have a branded blog, social network, discussion forum, etc. have a link to the PI prominently n the navigation or other links on the site.
You raise some interesting points about search. We focused solely on the social media realm, not the “traditional” interactive realm. We only touch on other Internet marketing to make the point that marketers don’t have to wait for FDA guidance to take advantage of new marketing forms.
That said, I agree. In a strict interpretation, paid search ads are probably verboten: given the space restrictions, there’s no way to get any sort of “fair balance” statement into an AdWord ad.
But I think it is more complicated than that. I just Googled High Blood Pressure. A Lipitor ad pops us but only says, “Visit Lipitor.com to learn ways to lower your cholesterol.” Click through and the first thing on the page is “Diet and Exercise”. The second heading on the page is “Cholesterol-Lowering Medication”.
I guess this is an example of one of the tricks you mention: within the confines of the AdWord text, they never make a claim or even explicity state the indication.
Are you saying that the act of buying the keyword and having their ad pop up is tantamount to including it as an indication in their ad? It would be interesting to do some consumer perception research: I wouldn’t be surprised if the consumer walks away with the link between Lipitor and lower blood pressure, in which case there could well be a cause for the FDA to issue a warning letter.
Note: Jim didn’t accuse me of ranting and made some interesting comments. For me, the issue with the Framework people was closed. Until, that is, Serio made his “rant” accusation and forced me to bring this up and into the open again.
BTW. I agreed with about 50% of the comments Serio made at the conference. He, on the other hand, said “when it comes to the Internet, you can only believe about half of 1% of what you read.” I forgive him for that statement since he admitted that he never read a blog or heard of Web 2.0 until Fard and Jim recruited him to help them write the Framework.
However, I did agree with Serio when he remarked that “the fear of monitoring these [social network] sites [because of requirements to report adverse events] is unfounded.”
Hope I didn’t misquote you John!