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The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products: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Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed.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.