Good Riddance to Old Guidance: FDA Intends to Purge & Revise. What It Means for Social Media Guidance Hopefuls

FDA has often said that developing guidance for applying regulations to social media is like nailing jelly to a tree. Actually, OPDP head Tom Abrams has said FDA would NOT "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter ... [because] those things are really big now, but you know what, two years from now who knows what the next thing [will be]?" He said that at an industry conference exactly two and one-half years ago (see "FDA's Abrams Spends 4 Minutes Discussing Social Media Guidance at ePharma Summit!").You know what? YouTube, Facebook, and Twitter are still here and there really hasn't been many new "things" unless you count Pinterest -- which has been picking up steam lately -- and Vine (see "Seen on Vine: Loopy 6-Second Pharma Videos").I guess Abrams is afraid that after "working very, very thoroughly and very hard" and having his people put in "extra hours" on developing SM guidance (see "FDA's Abrams Repeats Same Old (Empty) Promises Regarding the Issuing of Social Media Guidance"), such guidance will soon be out of date and need to be revised.As if FDA never purges and revises "old" guidance!Yes, FDA routinely retires and revises out-of-date guidance documents. In fact, the agency recently announced its intention to do precisely that in the Federal Register (see "Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances"):"The Food and Drug Administration (FDA) is announcing an initi...
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: #fdasm Guidance social media Tom Abrams Source Type: blogs