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--- home:mp:off-label [01.03.2012] – external edit 127.0.0.1
+++ home:mp:off-label [08.29.2012] – [Off-label prescribing of Marshall Protocol medications] paulalbert
@@ Line 5: / Line 5: @@
 <blockquote>Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well-informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. 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), an Investigational Device Exemption (IDE) or a 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.</blockquote>
-Since its founding in 2004, Autoimmunity Research Foundation (ARF) has worked hard to establish a "firm scientific rationale" for the off-label use of the medications used by the MP. Members of the ARF research team have engaged the medical research community through conferences presentations and peer-reviewed publications explaining the science behind the MP. Also, the open nature of the study site encourages outside feedback.
+In sum, a physician will meet FDA criteria as long as that physician fully documents any unusual events and keeps a good eye on the response of the patient.
-Further, the ARF has done everything possible, given its resources, to work with the FDA and NIH. For example, ARF applied for and was granted [[home:publications:applications_orphan_status|orphan drug status]] for minocycline and clindamycin in the indication of sarcoidosis.
+===== Establishing firm scientific rationale =====
+Since its founding in 2004, Autoimmunity Research Foundation (ARF) has worked diligently to establish a "firm scientific rationale" for the off-label use of the medications used by the MP. Members of the ARF research team have engaged the medical research community through [[home:publications|conferences presentations and peer-reviewed publications]] explaining the science behind the MP. Also, the open nature of the study site encourages outside feedback.
+Further, the ARF has done everything possible, given its resources, to work with the FDA and NIH. For example, ARF applied for and was granted [[home:publications:applications_orphan_status|orphan drug status]] for minocycline and clindamycin in the indication of sarcoidosis.
+===== Off-label prescribing is common ======
+Off-label prescribing is very common.(({{pubmed>long:22507695}})) Almost every physician will prescribe off-label occasionally, most will not even realize it.
 ===== Notes and comments =====

home/mp/off-label.txt · Last modified: 09.14.2022 by 127.0.0.1