A common question that arises in Ketamine clinic transactions is whether a clinic or physician (collectively, “healthcare providers” or “providers”) can use or promote Ketamine for off-label uses. The short answer is yes, subject to several caveats, as discussed below. However, before reaching the answer, it is important to define what “off-label” use means and whether the U.S. Food and Drug Administration (“FDA”) has jurisdiction over the healthcare providers to enforce off-label promotion.
What is “Off-Label” Use?
The term “off-label” means that a prescription is being used for an indication that is not set forth on the drug’s label. Labels must be approved by the FDA as part of the pre-market approval process and must contain certain information about the approved uses. See, e.g., 21 C.F.R. § 201.56(a)(3) (“The labeling must be based whenever possible on data derived from human experience.”). The label is prepared after, among other things, clinical trials have been completed and approved by the FDA. See, e.g., 21 U.S.C. § 505(i) (requiring clinical trials before a drug can be approved for marketing).
The FDA may decline a new drug application when, for example, the evidence fails to demonstrate the drug’s safety or “there is a lack