“What had been envisioned as a massive, all-encompassing guidance on Internet promotion is being retooled as multiple guidances to address specific issues in the online realm,” Tom Abrams, head of the Center for Drug Evaluation and Research’s Division of Drug Marketing, Advertising and Communications (DDMAC) said during a panel discussion at the Drug Information Association’s annual meeting in Washington, D.C., June 15. (Picked up from a “FDA Library Alert” email — “DDMAC: Social Media Guidance Likely To Be Split Into Multiple Documents” — I just received.)
Either I can see into the future, or FDA reads Pharma Marketing Blog and takes my advice. In November, 2009, I said “If FDA decides to bite off more than it can chew, it will take a long time to issue any guidance and whatever it comes up with will be out of date as soon as it is published. A much better approach would be to tackle a few issues at a time” (see “FDA Social Media Guidelines Best Done in Baby Steps“).
More from “FDA Library Alert”:
Abrams said the planned move from a single document covering all forms of online promotion — such as social media, webpages and videos — to multiple, targeted guidances will help future-proof DDMAC’s oversight of the web. It would give DDMAC greater flexibility in the event that new technologies emerge to supplant today’s online media.
“Technology is evolving so much, we don’t want the guidance to become quickly outdated,” Abrams explained.
He emphasized that this shift is not set in stone, but is simply the division’s “current vision” for the guidance. “It could change at any time,” he noted.
If the division does adopt this approach, the guidances will not be rolled out all at once, but over the course of time, Abrams said. He added that the first of these guidances will likely be released this year.
During the conference, Abrams also revealed that the Internet guidances likely would address specific issues or circumstances — such as the posting of unprompted data on off-label use of a product or the question of responsibility when off-label information is posted on a third-party site — rather than specific platforms — such as websites or Twitter.
Abrams declined to give a complete breakdown of the guidance topics envisioned or the number of guidances expected under this approach.
For more details, see the August edition of the FDA Advertising and Promotion Manual.