FDA expects drug company marketers to be mind readers

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By Richard Meyer on May 21, 2009


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The Food and Drug Administration said a Web video for the chronic-pain drug Ultram ER is misleading because risk information is displayed only at the end of the seven-minute video. OK, so what is different about the video than a TV ad where the risk information is at the end? Is it the length? And how are DTC marketers supposed to know what length is acceptable for risk information at the end? It looks to me like the FDA is once again saying "you do it and we'll let you know if it's OK" but the problem with this approach is that it usually prohibits risk by DTC marketing people to reach a consumers who are getting harder to reach.

I am amazed that DDMAC has not issued and guidelines around the use of videos on the Internet to promote and educate consumers. In fact DDMAC has not updated the guidelines around Web marketing for a long long time and they are as outdated as IBM electric typewriters. J&J did get slapped for more than having the fair balance at the end but how about letting the industry know what is acceptable and what is not?

The reality today is that marketing is changing and changing dramatically but direct to consumer drug advertising has remained stuck in the past. Sure there are some drug companies that are experimenting in social media but to date there has not been any wide scale implementation of trying new things, especially on the Web, because most drug companies are risk adverse. Can you imagine meeting with your legal and regulatory team to try and and get approval of new marketing initiatives when there are no guidelines? What are the teams supposed to do become mind readers of DDMAC personnel ?

John Mackhas called for an open meeting with the FDA on social media and I agree but it needs to be expanded to include all DTC marketing so that current guidelines can be brought into the present and reflect the realities of marketing products to a skeptical public that has more power than marketing people. It's long overdue and while they are at it they might want to invite the people from Nielsen Buzz Metrics, Manhattan Research and CRM Metrix so that they can give the FDA the data they need to show that patients are using the web to become empowered but more importantly they need to show the FDA HOW patients are using the Web. Long overdue