Thursday, August 12, 2010

Not all Risk - Fair Balance

I'm really baffled by the recent AdAge article about the Novartis warning letter. There's so many things in it to mention, but this passage is just factually incorrect.   Thanks to Jonathan Richman for the early morning post to Twitter that sent me off to read the article.
But according to the FDA's latest warning to Novartis, such a proposal wouldn't meet its threshold for including all risk information in any promotional material.
No, it doesn't say that. It says:
The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. (emphasis on "any" is included in the letter)
I've heard this before, when the famous 13 Warning Letters came out last year. I had a debate with a lawyer about this last year. He said the FDA was demanding the full "Important Safety Information" (ISI). I disagreed. If you read the words they are using, they are not saying that. What the FDA said then and said now is that the problem with these ads is there no risk present. There is no "fair balance." You can't have all sense of risk or safety information one-click away. You must balance it out.

AdAge also calls into question, because of this, the new Google Pharma-friendly PPC ad format. If this was really a "first shot across the bow" as the article claims, why wouldn't the FDA have already cited the widely publicized new PPC ad format? That would be an easy one. It's not like the ads, many for black box drugs, haven't been precleared.  The Google Pharma PPC ad format is exactly the model we should be looking at for this type of content.  It allows for "adequate provision" -- the inclusion of some risk information and how to learn the rest.

What the FDA is saying is that if a Pharma company puts a sharing tool on their website, they are responsible for the content shared. It is subject to the same rules as any other promotional content, and must include some risk information and be pre-cleared if it's for drug with a black box warning.

This isn't some big scary thing. It's really kind of simple. The only impact this will have moving forward is making Pharma companies really think about whether or not there is truly a benefit to having these tools on their websites, because the cost of implementing and submitting the content generated for legal review will have to increase to cover the additional level of effort involved.

For more, see the RTCRM Perspectivebriefing on this letter.


  1. Carlen,

    Not only did AdAge get that wrong, it also said:

    "Internet advertising revenue from the pharmaceutical industry reached $22.7 billion for 2009, almost half of which comes from search advertising..."

    $22.7 Bn is actually pharma's TOTAL ad spending, about 65% of which is for TV ads. Only about 5% or so of that goes to Internet advertising, INCLUDING search!

  2. I know. there was so much in that article that was just wrong. I decided to pick the thing that was most offensive to me! This statement also drove me nuts: "Drug advertising generally comes under stricter guidelines than other forms of advertising, "

    Really? "generally comes under" -- it always comes under stricter regulation than other forms of advertising.

  3. I still fail to comprehend why Pharma companies still invest so heavily in awareness and direct response television, given the fact that digital media offers significantly greater target-ability and consumer behavior pathway/touch point accountability. I'm hoping this changes over time, as so many consumers are time shifting their TV viewing habits, and often skip over the TV commercials

  4. I think the issue for them is always that they are afraid to miss those people who aren't easily accessible online. It's a smaller and smaller group of people, but there are still enough that you can't effective reach solely through online.

    I think you're right that we need a better balance these days. I'm definitely someone easier to reach via Hulu than broadcast. And even my husband, who we all know is not the techie in the family!