Off-label Drug and Device Applications: Meeting the Challenge

Abstract

As aesthetic surgeons constantly in search of the best treatments for our patients, we often find ourselves considering the benefits and risks of off-label uses for drugs approved by the Food and Drug Administration (FDA) and cleared or approved medical devices. The Aesthetic Surgery Journal ( ASJ ) publishes many articles that detail off-label medical product applications; such articles are among the relatively few available sources of off-label drug and device guidance. The relative lack of genuinely scientific information on off-label drug and device use poses a continuing challenge for medical practitioners. The FDA acknowledges that peer-reviewed medical journals are important resources for physicians who seek unbiased reporting on new and unapproved uses of medical products. At the same time, it continues to uphold strict guidelines regarding manufacturer dissemination of journal article reprints. Agency recommendations for “good reprint practices” include specifications for the types of articles, types of publications, and methods of dissemination that are acceptable.1 A manufacturer’s failure to adhere to these guidelines could result in enforcement action consistent with the prohibition on promoting an unapproved use of a medical product. The FDA, in this instance, essentially endorses many of the same standards for journal articles that the Editorial Board of ASJ seeks to promote—namely, a preference for well-controlled clinical investigations that can withstand the rigor of expert peer review. Yet studies that yield the highest levels of evidence (such as prospective randomized double-blind trials) are not available on every topic of clinical importance, and this is certainly true regarding many common off-label uses of drugs and medical devices. Articles such …