Thanks to my friend Mark Senak (of Eye On FDA blog) for breaking the news/story late last night (DEC 20th) that the FDA has announced a delay on the issuance of Internet and Social Media Guidance, that was originally planned for release by the end of 2010 (or at least part of it).
According to Mark, an email was sent by the Center for Drug Evaluation and Research (CDER) announcing the following:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:
- Responding to unsolicited requests
- Fulfilling regulatory requirements when using tools associated with space limitations
- Fulfilling post-marketing submission requirements
- On-line communications for which manufacturers, packers, or distributors are accountable
- Use of links on the Internet
- Correcting misinformation
Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.
You may recall that this all started with the FDA Open Forum to address Internet and Social Media guidance in NOV 2009. Over the course of the year since then, general chatter and bits of information that were revealed at various conferences where the FDA presented, etc. (e.g. see Pharma Marketing Blog, NOV 1st, 2011) suggested that the FDA was planning to release guidelines: (1) by the end of 2010, (2) in a modular format, and (3) that would not address Adverse Event issues initially.
While many have been skeptical about the timing and some even had countdown clock widgets installed on their blogs , I believe many were holding on to a glimmer of hope that something would at least give us an indication for what to expect. In fact, I was at a recent conference in NYC, where an attendee asked a speaker from CDER if they could even just confirm a general date/timeline for when to expect the guidelines. So…I guess that’s what we have for now–a vague sense of what to expect. I guess we’ll just have to wait and see what happens in Q1, 2011.
Also see other commentary on this issue: