What if it’s better for the industry if the FDA simply never releases social media guidance?
The hand-wringing has been going on since before the FDA’s November 2009 hearings on Internet and Social Media promotion, and the voices get more shrill with every missed deadline (first the end of 2010, then Q1 2011, now ongoing with no real deadline). Much of the discussion centers on the missed deadlines and theorizes that the lack of clarity is keeping pharma companies from using social media. At Klick Pharma, we don’t see evidence of that as many our clients have already created internal guidelines based on the known FDA parameters -re-purposed- for social channels.
The FDA says “suck it up”
The FDA seems to condone this approach. Tom Abrams, Director of the FDA’s DDMAC, said the following at the Drug Industry Alliance conference:
There will be guidance on some specific matters, but there will be no new regulations or new standards. Look at our recent Warning Letters involving social media, such as Facebook. These Warning Letters cite existing rules and do not make new policy. (emphasis mine)
This is in contrast to the policies created in 1997 for broadcast advertising such as TV and Radio. Even though there were repeated calls for similar “reasonable accommodation” rules during the November 2009 public hearings, all indications are that DDMAC is not interested in following that path for social media.
Further, the latest news is that the FDA is starting the somewhat onerous process of conducting four studies on fair balance in internet communications. These studies are quite specific in that they are testing specific layouts of information on digital displays, primarily web browsers:
The studies do not seem to touch on mobile devices or social media channels in any way but it is probably a safe bet to say that the FDA will hold off releasing any social media guidelines until they are complete.
Does it really matter?
I agree with Abrams’ quote above “the policy isn’t changing so the lack of guidance should not be an issue for the industry.” A careful interpretation of what provokes an FDA letter, and what does not, gives the industry enough visibility into the guardrails to participate, if it chooses.
If you’re looking for a complete view into how to interpret FDA policy in digital channels, download the Klick guide.
Maybe it’s better this way
Rather than calling for social media guidance, perhaps we should really leave well enough alone.
Recent guidelines from the UK essentially make it impossible for pharma there to participate in social media at all. I for one would not want any guidance from the FDA that took that stand. To be fair, the FDA is not known to be overly influenced by other jurisdictions; its repeated defeats in the Supreme Court by the “freedom of speech” defense make it distinct (for a history, see this PDF). That said, having other enforcement agencies essentially saying “no” to social media is not a good precedent and it may well be that the status quo is pharma’s best option at the moment if it wants enough room to experiment. This all reminds me of something my mother used to say: “Be careful what you ask for, you may get it.”