Sailing the Straits of Approval: The Nature of FDA Approval and Its Implications for Surgeons

Use of Food and Drug Administration–approved medications and products for other than the approved indications is common in facial plastic surgery and violates no laws. Addressing practical concerns about such use strengthens the doctor-patient relationship and can minimize the risk of successful allegations of negligence in the event of untoward outcomes. The facial plastic surgeon can find support and assistance with off-label use in two general areas. Abundant scientific literature focuses on off-label use and addresses its practical, scientific, legal, moral, and ethical issues. The Food and Drug Administration also addresses off-label use in its own publications. It offers guidelines for physicians that, if followed, facilitate incorporation of off-label use into practice with minimal risk and maximum potential for therapeutic success.