For those just back from the FDA social media hearings in
Many blogs and tweets have already discussed what we learned at the hearings, but here are a few things we didn’t learn:
– Whether social media is really a channel for patient acquisition. I counted only 4 or 5 speakers (of the 50 I watched) who mentioned the word “compliance” or “adherence.” But go to any message board or blog where patients are discussing a medication. You’ll find that the discussions there are mostly about a drug’s side effects, how to take it properly, how to know when it’s working, interactions with other medicines, and so on. These are the concerns of customers, not prospects, and at the hearing, that vital difference was rarely called out. The notable exception came from entrepreneur Zen Chu, who called for FDA to distinguish between “prescript marketing” and “postscript education."
– Whether the spread of social media neglects patient health literacy. Jim Walker of Cadient Group asserted most user-generated content does not take into account patient reading levels. I couldn’t agree more, but FDA panelists poked at his theory, questioning whether patients with low literacy use the Web. Really? The average American reads at the eighth- to ninth-grade reading level, per the National Center of Education Statistics. I used a Fry graph—a tool our health educators often employ to determine one aspect of literacy—and assessed a sample Wikipedia page on “hypertension.” The entry was written at the 15th-grade reading level. (Need more proof of the importance of literacy in social media? Search the term “hypertension” and see what comes up.)
– How a proposed FDA “seal of approval” might work. It’s a compelling idea that could protect manufacturers and build consumer trust. FDA panelists asked a number of questions of proponents of this idea, indicating their interest. Several concepts were presented, among them PhRMA’s “FDA Approved” logo (PDF) pictured here. But nobody suggested a process that would allow FDA to ensure its seal was used only by regulated companies for approved content. If the seal concept gains traction, FDA may want to speak with TRUSTe, the company that pioneered the online privacy mark, or VeriSign, whose seal protects private data using digital signatures.
– What FDA thinks of the current Medwatch.com. This was a typical comment echoed by many speakers at the hearings: “The Medwatch Web site is terrible—consumers aren’t going to fill out that giant form!” Clearly FDA realizes the Medwatch program must change with technology. That obviously influenced the agency’s recent guidance on mandatory electronic safety reporting for manufacturers. For consumer adverse event reporting, FDA has some choices to make. Will it hire more staff and beef up its reporting Web site, as suggested by the
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