Off-Label Does Not Mean Off-Base

Abstract

The off-label use of approved medical devices and drugs in a responsible manner is integral to the practice of medicine and interventional radiology in particular. The prerogative of physicians to utilize U.S. Food and Drug Administration (FDA)–approved products for unlabeled indications that are supported by substantive clinical evidence has been asserted and confirmed on numerous occasions ( 1 AMAAMA H-120.988 Patient Access to Treatments Prescribed by Their Physicians. http://www.ama-assn.org/apps/pf_new/pf_online?f_n=resultLink&doc=policyfiles/HnE/H-120.988.HTM&s_t=off-label&catg=AMA/HnE&catg=AMA/BnGnC&catg=AMA/DIR&&nth=1&&st_p=0&nth=2& Google Scholar , 2 SIRSIR Policy on Off-Label Use. http://sirweb.org/clinical/cpg/SIR_Off-label_use_statement11-18-07.pdfDate: 2007 Google Scholar , 3 Smith J.J. Berlin L. Off-label use of interventional medical devices. AJR Am J Roentgenol. 1999; 173: 539-542 Crossref PubMed Scopus (17) Google Scholar ). As stated by Yustein et al ( 4 Yustein A.S. Schultz D. Neuland C. et al. The FDA and off-label use of expandable metal biliary stents within the peripheral vasculature. J Vasc Interv Radiol. 2008; 19: 965-969 Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar ) in this issue of JVIR, the FDA does not dispute this practice. The FDA's concern is specific to expandable metal stents and the less rigorous testing requirements for biliary compared to vascular devices. Biliary stents are class II, or intermediate-risk devices, whereas vascular stents are class III, or high-risk devices. Class III devices undergo more extensive benchtop and clinical testing before final approval than do class II devices. During the past several years, the FDA has received increasing numbers of reports of adverse events involving the vascular use of expandable metallic stents that only have biliary approval. These events are publicly listing in the Manufacturer and User Facility Device Experience (MAUDE) database at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm. The authors, as have others, strongly suggest that these adverse events are directly related to the off-label use of devices that have not been adequately tested for the vascular environment ( 5 Bridges J. Maisel W.H. Malfunctions and adverse events associated with off-label use of biliary stents in the peripheral vasculature. Am J Ther. 2008; 15: 12-18 Crossref PubMed Scopus (12) Google Scholar ). U.S. Food and Drug Administration and Off-Label Use of Expandable Metal Biliary Stents within the Peripheral VasculatureJournal of Vascular and Interventional RadiologyVol. 19Issue 7PreviewExpandable metal stents are used to maintain the patency of compromised ducts, lumens, and vessels. As medical devices, these products are regulated by the Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA). During the past several years, the FDA has become aware of the increasing prevalence of off-label use of expandable metal stents cleared for biliary use within the peripheral vasculature. The authors provide an overview of how the FDA regulates medical devices and expandable stents and summarize safety issues reported to the Agency with regard to the off-label use of these biliary stents. Full-Text PDF