Off-label prescribing of Marshall Protocol medications

Many of the Marshall Protocol (MP) medications are prescribed “off-label”, which is to say that they are employed for a purpose outside the drug's approved label. Other countries have different policies, but the US FDA has issued clear Policy Guidance on off-label prescriptions, clearly stating that it is up to the physician's individual judgment to decide whether an off-label drug should be used.

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.

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.

Since its founding in 2004, Autoimmunity Research FoundationNon-profit foundation dedicated to exploring a pathogenesis and therapy for chronic disease. (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 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 orphan drug status for minocycline and clindamycin in the indication of sarcoidosis.

Off-label prescribing is very common.¹⁾ Almost every physician will prescribe off-label occasionally, most will not even realize it.