tag:blogger.com,1999:blog-1732132352927731247.post6555207272948287788..comments2024-03-16T00:27:31.848-07:00Comments on Hooked: Ethics, Medicine, and Pharma: Spinal Fusion Devices: What's the FDA Hiding?Howard Brodyhttp://www.blogger.com/profile/00599587504924835039noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-1732132352927731247.post-16957270629693156762010-08-31T12:52:38.177-07:002010-08-31T12:52:38.177-07:00Anonymous-- thanks for the clarification and I apo...Anonymous-- thanks for the clarification and I apologize for any misimpression. I agree that institutions could, if they wished, do much more to crack down on off label use, which I think is the most important point; and I appreciate your clarification that this could fall under the role of the IRB. Thanks again, HowardHoward Brodyhttps://www.blogger.com/profile/00599587504924835039noreply@blogger.comtag:blogger.com,1999:blog-1732132352927731247.post-60759635328906378092010-08-30T14:36:48.436-07:002010-08-30T14:36:48.436-07:00Thank you for your reply Howard. With all due resp...Thank you for your reply Howard. With all due respect, IRB's have the authority and latitude to require approval prior to using any product for off-label use. <br /><br />The FDA in their guidance on off-label use states:<br /><br /> "Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight."<br /><br />I believe that while FDA needs to step up on these issues (as a former FDA investigator) I also believe that hospitals and other professional licensing and accrediting bodies also need to step up to their responsibilities.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-1732132352927731247.post-7373213062720162902010-08-30T07:45:20.538-07:002010-08-30T07:45:20.538-07:00In reply to Anonymous, it's important to keep ...In reply to Anonymous, it's important to keep in mind that once a drug or device is approved by the FDA, physicians legally can prescribe it for any use their judgment dictates, including off-label uses. The decision to use a drug or device off-label in any given patient is therefore NOT an investigational use, and no IRB approval need be sought. So IRB's are completely out of the loop when it comes to regulating off-label prescribing. The proposals now circulating call for stricter informed consent requirements if a physician is going to use a drug/device off label, so that at least the patient should be aware--but again, this is informed consent in the therapeutic and not in the research context. Thanks for writing, HowardHoward Brodyhttps://www.blogger.com/profile/00599587504924835039noreply@blogger.comtag:blogger.com,1999:blog-1732132352927731247.post-88256725643594382172010-08-30T06:42:21.686-07:002010-08-30T06:42:21.686-07:00I'd like to know where the hospital IRB's ...I'd like to know where the hospital IRB's are. If these surgeons are using the devices off label, that would be considered an investigational use, right? As such it should fall under the auspices of the IRB to review and approve these surgeries. <br /><br />It seems not only the FDA is negligent here but also the oversight committees at the local level as well. Doctors of course have their own profit driven motivation for recommending said surgeries. Who oversees the doctors?Anonymousnoreply@blogger.com