Why the FDA Needs to Accept PhRMA's Social Proposal

Patients Are Researching 21st-Century-Style, Marketers Need to be Able to Be There Too

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Josh Bernoff
Josh Bernoff
The pharmaceutical industry and the FDA are in a strange position.

People are discussing drugs and treatments all over net, from WebMD to the American Cancer Society's Cancer Survivors' Network.

But pharmaceutical companies can't encourage or participate in this activity in any way. In one case in my research, a pharma company employee begged me to take down a reference to a site her company had sponsored -- the logo was right there on the site -- even though the company had provided an unrestricted grant and did not influence content in any way. This level of hypocrisy is absurd, and serves no one.

Now PhRMA, the pharmaceutical industry organization, is proposing the creation of a logo that could be placed on social sites to indicate where information that meets the FDA's guidelines for fair balance, non-promotion of off-label uses, reporting of adverse effects, and other regulations would be strictly followed.

This is an ideal way out of the current state. The logo should be prominent. Furthermore, I think pharma companies should moderate and appropriately respond to social activity, including blocking off-label suggestions and following up on adverse effects. This works now for GSK's Alli community, which exists only because Alli is an over-the-counter drug and therefore is not subjected to the same level of scrutiny by the FDA. Sure it's expensive to do this moderation, but Alli shows it can be done, and effectively. Pharma companies are enthusiastic about social media but terrified by the lack of FDA rules, which means they never know if they'll be cited for inappropriate behavior.

It's time for the FDA to indicate what behavior is appropriate, including moderation and the logo linking to fair-balance information. Then people who need information about medications will be able to benefit from peer content. It's a lot better idea than leaving all that peer content on unregulated sites, and allowing pharma only with ads with pages of small print disclaimers. How 20th century.

Josh Bernoff is co-author of "Groundswell: Winning in a World Transformed by Social Technologies," a comprehensive analysis of corporate strategy for dealing with social technologies such as blogs, social networks and wikis, and is a VP-principal analyst at Forrester Research. He blogs at blogs.forrester.com/groundswell.
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