I just downloaded the “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2011” from the FDA site (find it here).

Missing from this agenda is “Promotion of Prescription Drug Products Using Social Media Tools”, which WAS on the 2010 Agenda (see here).

However, included in the 2011 agenda under the Advertising Category is “Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet.” Is this supposed to be the promised guidance we’ve all been waiting for? “Responding to unsolicited requests” is NOT a social media issue nor was it one of the questions FDA asked at the November 2009, public hearing (see all the questions here).

I don’t know who/what to believe. In February, 2011, Tom Abrams, Head of DDMAC, said “We want to have these [social media] guidances out as soon as possible” (see here). FDA set the end of the first quarter of 2011 as the deadline goal. It missed that goal and hasn’t set a new one. Now I see that the 2011 Guidance Agenda doesn’t even include social media guidance.

I don’t think the FDA is being very transparent and is sending the industry conflicting signals. What do you think?

P.S. See “Breaking – Its Official – FDA Delaying Social Media Guidance Until at Least Q1 2011” which highlighted email from the FDA that had “Responding to unsolicited requests” at the top of the list of social media issues the FDA is researching for draft guidance.

Although social media and the Internet expose pharma companies to unsolicited requests (ie, when they allow comments on Facebook or follow people on Twitter) it is NOT an issue that was discussed at the November, 2009 Public Hearing nor in the comments submitted to the FDA regarding social media.

[I stand corrected. The issue of how to respond to “unsolicited statements” about off-label use of drugs on pharma-owned social media sites WAS discussed at the hearing. See  see “First FDA Social Media Guidance to Address Responding to “Unsolicited Requests” for Off-label Information“]

Writing guidance for handling unsolicited requests is a no-brainer compared to developing guidance on how pharma marketers can comply with FDA regulations when space is limited as in search engine ads and tweets. Why isn’t the FDA tackling THAT all-important social media issue first? After all, those infamous 14 NOV letters were all about that and NOT about handling unsolicited requests. For my answer to that mystery, see “FDA, DOJ, & Google: Conspiracy Theory, Part 2.

P.P.S. I called and e-mailed Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC. Here’s the response I received from her via e-mail:

Hi John,

Thanks for your voicemail and e-mail messages. You should have received an autoreply e-mail from this account with the current status of our policy and guidance development on Internet/social media promotion, which is an Agency-wide effort that involves an extensive work and review process. While “Responding to unsolicited requests…” is listed by name on the 2011 CDER Guidance Agenda, it is only one of multiple topics for which we plan to issue draft guidances. At this point I cannot provide any specific timeframes due to our GGPs as many parties are involved, not just DDMAC. Please know that we are committed to moving forward with policy development in this important area by issuing well-vetted and meaningful draft guidances!



P.P.P.S. For a follow up, see “First FDA Social Media Guidance to Address Responding to “Unsolicited Requests” for Off-label Information“.