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.