It is recognized that the occasional “off-label” use of products is deemed necessary by physicians to be in the best interest of their patients. “Off-label” refers to the application of a product (drug or device) for a purpose other than that specifically approved by the U.S. Food and Drug Administration (FDA). The following steps must be taken before an off-label use can occur*:
1. If available, correspondence from another institution or colleague or documented studies, either submitted or published, will need to be provided to Lynne Dockser in OR/CSS, demonstrating that the product has been used in other institutions for the indication proposed.
2. – If the physician intends to review data from the off-label use for possible public presentation or publication (i.e. to perform research, defined as a systematic collection of information to answer specific questions for general knowledge), then the FDA and HHS regulations require submission of a protocol to the Institutional Review Board (IRB). See the IRB website for more information on distinctions between research and clinical care and for contacts at the IRB to discuss these issues. IRB chairpersons are Julian Seifter, MD, Elizabeth Hohmann, MD, Andrew Budson, MD, and Lawrence Tsen, MD.
Chief Medical Officer Andy Whittemore, MD and/or appropriate chief of service will be asked to review each request. Note that these steps are intended to protect both the hospital and physicians from liability exposure for certain off-label uses of FDA approved products.
* If the off-label use is required to treat a patient in an emergency, then Whittemore or, in his absence, the appropriate chief of service, should be notified as soon as possible.