In March 2009, the FDA stated its first outlines for its approach to the regulation of social media and the Internet with a podcast with Jean Ah-Kang at the Division of Drug Marketing, Advertising and Communications that said it was not the medium, but the message that was at the basis of FDA’s regulatory outlook on social media.
Subsequent to that, the agency convened a two day public meeting in November to solicit input from the public for what the agency’s approach should be, posing a number of wide ranging questions to the public. Through the meeting and the docket, scores of statements were submitted.
Since then, it has been often repeated by representatives of DDMAC that they would issue a guidance, or at least a partial guidance, by the end of 2010, and there has been much chatter about it on Twitter and in the blogosphere. However, the stated aim always came with the caveat that 2010 was a goal, but not a date set in stone.
Tonight, I bring you DDMAC’s latest statement on the issuance of a guidance on social media and pharma communications sent from the Center for Drug Evaluation and Research by email:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products: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Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed.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.
And so now we know that it may be first quarter or beyond.
Pingback: Twitted by skypen
Pingback: Breaking – Its Official – FDA Delaying Social Media Guidance Until … | Media Point - O Ponto de Encontro de todos os interessados nos Media!
Pingback: Med 2.0 » Blog Archive » FDA Delays Social Media Guidelines Till Q1 2011
Pingback: Is the FDA Hurting or Helping the Market by Delaying the Social Media Decision? « The Full Spectrum Blog
Pingback: Scrooge FDA Delays Laying Social Media Guidelines Golden Egg: Why? | Pharma Marketer
What a shock! I thought they were right on top of this! 🙂
Pingback: FDA Delays Social Media Guidelines Till Q1 2011 | Pharma Marketer
[…] 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 released by the end of 2010 (or at least part of […]
Pingback: FDA Delays Social Media Guidelines Till Q1 2011 | Pharma Marketer
[…] 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 released by the end of 2010 (or at least part of […]
Pingback: Delay on FDA Social Media guidance is no surprise « On Message
Pingback: FDA Delays Guidance On Social Media | Pharma Marketer
Pingback: FDA Misses Own Deadline On Social Media | TRA360
Pingback: FDA Outlines Plans, Timing for Social Media Guidances | Pharma Marketer
Pingback: Social Media » Pharma Marketing Blog: Scrooge FDA Delays Laying Social Media …
What a shock! I thought they were right on top of this! 🙂
Pingback: Things to Look for in 2011 | Eye on FDA
Pingback: FDA social media regulations for Twitter and Facebook - Gases & Welding Blog | Welding & Gases Today
Pingback: FDA to Start Regulating Social Media
Pingback: Some Major Agency Actions Will Slip Through Cracks of President’s “Improving Regulation” Order « The Legal Pulse
Pingback: The FDA Guidance System Needs a Fix | Eye on FDA
Pingback: Part II of the Top 10 Sustainability / CSR and Online / Social Media Marketing Trends for 2011 | 4 Green Ps
Pingback: Odds, Ends and Updates | Common Sense
Pingback: Major Agency Actions Slip Past Obama’s Order to Cut Regulation - On the Docket - Inside the courtroom - Forbes
Pingback: Pharma biotech and their use of social media | Lacerta Bio
Pingback: Social Media is Not the Future of Study Recruitment
Pingback: BREAKING – Latest Statement from FDA on the Draft Guidance on the Internet and Social Media | Eye on FDA
Pingback: BREAKING – Latest Statement from FDA on the Draft Guidance on the Internet and Social Media | Pharma Marketer