- “Off-Label” refers to use of an FDA-approved drug or device for an unapproved use to treat a medical condition. Off-label risks may be unknown until after FDA approval and public release. Patients presume FDA testing has already occurred and has been approved for use in their treatment.
- The vast majority of courts (but not all) have held that a provider need not get formal written patient consent to use off-label drugs and devices.
- A provider should consider more than the legal requirements when recommending off-label treatments. Consider the ethical elements of beneficence, non-malfeasance, justice and autonomy. Autonomy is the principle that individuals have a right to make their own choices.
- Not all off-label uses are created equal. Some cases require additional scrutiny. Consider the differences in the risk/reward balance in prescribing off-label with new drugs or devices, novel off-label uses, treatment with known serious adverse effects, and with high cost off-label drugs.
- Categorize the potential offlabel uses depending on whether the patient will gain a net benefit. Use net benefit when deciding whether to use a formal written consent. Individual circumstances may determine the need for more formal consent.
- The prescriber always has a responsibility to act reasonably. Even with patient consent, the physician must act within the standard of care or be subject to medical board disciplinary action.
