Labeling (Package Insert): Meaning* by the Food and Drug Administration of Not Recommended, Not Indicated, and Off-label Use

Virginia Mason Medical Center, Seattle, Washington. daniel.moore@vmmc.orgThe article from the Food and Drug Administration (FDA) by Chang et al. 1was erudite. And it stated, “The views … do not necessarily reflect those of the Food and Drug Administration.” However, in my opinion, shouldn’t it have alerted anesthesia practitioners to the FDA’s interpretation of these terms?In 1983, Patricia H. Russell, M.D. (deceased, Acting Director of the Division of Surgical-Dental Drug Products, Office of Drug Research and Review, Center for Drugs and Biologics, Department of Health and Human Services, Public Health Services, Food and Drug Administration, Rockville, Maryland), stated, (1) “Not recommended and contraindicated as viewed by the FDA are close to being synonymous”; (2) “Not indicated and not recommended is ‘virtually’ saying the same thing”; (3) “… not indicated is simply that the drug is not indicated for that particular use because nobody has studied it in that particular use”; and (4) “Not recommended puts the onus squarely back on the practitioner in that we are saying that we (FDA) cannot recommend the use of the drug.”2In regard to “off-label use,” she stated, (1) “… if you feel that you can justify the use of that (not indicated, not recommended) drug by putting a note on the chart and defining why it is you are using the drug in that particular patient, then the responsibility is yours,” and (2) “To study a drug for a new use requires they (anesthesia practitioners) or the pharmaceutical company submits to the FDA an IND (investigational new drug) application.”2Are these quotes still valid, has the FDA officially restated them, and if so, where?Virginia Mason Medical Center, Seattle, Washington. daniel.moore@vmmc.org