FDA "On Track" to Issue Internet/Social Media Guidance in 2010

I read with interest this understated - yet important - tiny blurb that appeared in my June issue of MM&M Magazine this week (pg. 9):

"Kang: online guidances due in 2010"

I was not able to find the article online, or I'd link to it. But basically it states that:

FDA is on track to issue draft guidance this year on promotion of regulated medial products using the internet and social media, the agency's Jean-Ah Kang told MM&M.

The rest of the short article quoted Dr. Jean-Ah Kang, special assistant to DDMAC director Tom Abrams, and re-caps all the details and statistics around the November 2009 hearing and subsequent docket submissions. The guidance is expected to address four of the five topics mentioned in the Federal Register notice. (They won't give guidance on adverse event reporting, since that's regulated by CDER  and CDRH.)

What caught my eye is that here, in June, an official representive of FDA is publicly stating on record that they are on track to deliver guidance by the end of this year. Although that's a timeline we've heard a few times before, I've been a bit skeptical about if DDMAC would really get it done. If they do? Kudos to them; I will be very impressed. And it will also make me wonder if they already had guidance drafted prior to the hearings.

Either way, I think we'll all be somewhat relieved to finally have those FDA-sanctioned "guardrails" everyone's been talking about. Then again ... I guess that depends on what the guidance will say and mean. The way I see it, that could go one of three ways:

1. The More Things Change, the More They Stay the Same. FDA's guidance will echo what we already know: the same rules apply for online marketing as those that were created for offline years ago. Marketing must be on-label, not false or misleading, balanced, and provide adequate evidence for claims.

2. Clarity is the Remedy.  FDA's guidance may provide more direction on how pharmaceutical companies can legally connect with consumers and professionals online, including via social media. Perhaps they will even make some provisions for how to fit fair balance into spaces like a Twitter post. Perhaps they will address the long-fabled "one click rule."

3. Be Careful What You Ask For. We may receive clear guidance, but we may also not be happy with what we get. Based on the FDA's extremely conservative approach this year and extremely busy warning-letter-writers, it doesn't bode well. What if FDA essentially says pharmaceutical marketers can't mention brands in Tweets? What if they disallow unmoderated user-generated content in pharma-sponsored social spaces? I actually don't think they'll be that specific, but I am a bit concerned that we may see guidance that has far-reaching implications for what will -- and won't -- be do-able in 2011.

Stay tuned ...