Up until now, online social networking has been treated mostly as a plaything for some pharmaceutical manufacturers. They will post a few updates on Twitter, maybe start a Facebook page or post a YouTube video or two, but I have not seen much indication that the companies have really bought in, much less that they “get it” (though, some like AstraZeneca may be playing it safe while the FDA works out the regulation aspect).
Eye on FDA has a good summary of what’s happened to get us to this point. Initially, the FDA was more concerned with the content of pharmaceutical and medical device manufacturers’ messages. However, last year the FDA realized that there is only so many contraindications you can fit in 140 characters. So, in September 2009, they took the proactive step of setting a meeting (which BigPharma interestingly did not attend), and encouraging comments (open through last month). The hope is that they will be able to draft some sort of guidelines, so everyone knows where the line is.
But, comments have been received at the 11th hour by the following companies: AstraZeneca, Pfizer, Merck, Lilly, Medtronic, Novartis and Abbott. AstraZeneca posted a link to their statement submitted to the FDA, and mentioned their core principles for social media on their blog:
- Truth and Accuracy: Content that is truthful, balanced, accurate, and not misleading
- Be Respectful: Respect the interests of patients, caregivers, and health care providers, particularly related to matters of privacy and the primacy of the patient/physician relationship
- Protect and Advance Patient Health: Provide accurate and timely reporting on medicine safety
- Transparency: Any sponsorship should be entirely transparent as to the role of product sponsors as participants in online discusions [sic]
- Respect the Views of Others: Acknowledge other opinions but don’t censor or limit these views; rather, add the product sponsor’s views to the ongoing discussions
Importantly, AstraZeneca claims that it has taken the noble step of limiting their social networking to “corporate, non-product information.” That is a wise and responsible decision, given the current lack of regulation. But, AstraZeneca is poised to become a leader in the social networking drug world: they have no less than one blog, three Facebook pages (including one for Nexium—perhaps AstraZeneca forgot about that one when they said they are not talking about products?), three Twitter accounts, and three YouTube sites. Their proposal identifies many of the challenges ahead—how will the FDA’s regulation fit in with regulation from other nations? What responsibility does a manufacturer have for content posted on-line by third parties (for example, Google Sidewiki)? How do promotional rules apply to space-restricted social networking, like Twitter? Does “big picture” regulation (i.e., not regulating each post) actually work, given how consumers are going to use each form of social networking?
I have not seen the other submissions, but I will be on the lookout and will post links as they come up.