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.
Reiter
David
D
Department of Otolaryngology-Head & Neck Surgery, Jefferson Medical College, 925 Chestnut Street, 6th Floor, Philadelphia, PA 19107, USA. david.reiter@jefferson.edu
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D013518:Surgery, Plastic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*