The Food and Drug Administration recently finalized its guidance document entitled, “Good Reprint Practices for the Distribution Of Medical Journal Articles and Medical Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (the “GRP Guidance),” which describes the conditions under which FDA will allow drug and device companies to proactively disseminate certain off-label use information. Because dissemination of off-label information has the potential to affect product liability exposure, it’s worth examining the content of the GRP Guidance carefully. To illustrate the point, I note that the GRP Guidance and the recent sermon of my pulpit Rabbi share similar characteristics. Both focus on the potential of good news, but also offer a note about caution in saying too much.
Click the link below to read the full alert.