Use of an Approved Drug in an Unapproved Manner in the Practice of Medicine Physicians credentialed by the CC, like all licensed physicians, may use any approved drug for any indication that they believe would benefit the patient. The practitioner must be the final judge of how to prescribe an approved drug. Although FDA approval for a specific use may be lacking, information supporting that use may exist, even though the manufacturer's label does not indicate the specific use. This situation may occur when a pharmaceutical company has no economic incentive to gain FDA approval for an additional indication for an already approved drug. Using an approved drug in an off-label manner can make it harder to defend against a tort claim.
Jurisdictions view the absence of labeling differently.
Regardless of the jurisdiction, however, physicians should inform the patient of what is being done. Although the CC does not have official policies on the matter, the physician should consider placing a note in the patient's medical record describing the information exchanged with the patient. The responsibilities and issues applicable to the sponsor-investigator are addressed definitively in 21 CFR 312. The IRB is responsible for ascertaining that an IND has been filed if needed. The sponsor may be an individual, such as the PI or an AI, a pharmaceutical company, governmental agency, academic institution, or private organization.