By Ed Silverman
Originally published February 29, 2016
Drug makers have long argued that the Food and Drug Administration is squelching their free speech rights by barring off-label promotion of their medicines. A new proposal may give them a voice.
This month, a think tank at Duke University called for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.
Companies say current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their medicines. The FDA worries public health can be compromised if marketing claims aren’t backed up by solid evidence. A neutral third party, the authors of the white paper say, could provide much-needed arbitration.
The article is here.