Abstract
Unsolicited inquiries for off-label medical/product information are the focus of compliance monitoring programs as described in regulatory guidance published by the US Office of the Inspector General (OIG) and the US Food and Drug Administration (FDA). Pharmaceutical industry medical information departments (PIMIDs) are encouraged to monitor and report on patterns of activity, including the source and frequency and types of off-label inquiries received. Especially of interest are unsolicited off-label inquiries triaged via sales representatives. By tagging all response documents with "compliance topic" codes that reflect the type of off-label inquiry (eg, unapproved indications/uses, more detailed or extended data, adverse events, etc) and specifically tracking for the inquiry source route, our PIMID was able to analyze and compare customer inquiries including those triaged by sales representatives. In an analysis of all inquires (n = 20,213) received over a 2-year period (2010-2011), it was observed that inquires submitted by sales representatives after unsolicited health care worker (HCW) requests accounted for only 14.8% of requests overall. Questions related to "off-label indications/uses" (ie, compliance topic of most interest to regulatory agencies) accounted for 5.8% of all inquiries and were almost equally distributed in number between sales representative triage and HCW direct calls to the PIMID. For the set of sales representative triage submissions in 2010 and 2011, the "off-label indications/uses" category accounted for 15.3% to 20.5%, respectively, and was statistically significant ( P < .001) for the rate of 4.8% to 8.1% observed collectively for all customer sources. In most cases, there were similarities in questions asked (top 5 ranking) and their geographical source for sales representative triage versus customers directly.