Good-bye to the Good-bye Presents
As most here will know, as part of their final act, the political appointees and (most likely) some of the FDA career staff declared a change in guidelines for off-label promotion of drugs. The core of the new guidelines is that FDA would not require prior review of the off-label promotional materials when they were used for marketing to docs. The text about "peer-reviewed journals" remained.
As is conventional, those proffering the guidelines said that this was only formalizing what was already policy. Those not inclined to agree described the change as one more last-ditch attempt to save the world for off-label promotion. Given that the past few weeks have seen the largest busts for off-label promotion in history - both Lilly/Zyprexa and Pfizer/Bextra - adds a little irony to the development.
The Fort Worth Star Telegram reports that both the administration and key members of Congress - particular Senator Grassley and Representative Waxman - will act to reverse the guidelines.
Dare I ask: Opinions out there?