Compliance Within Medical Information and the Emergence of a Medical Information-Dedicated Compliance Person: A Benchmarking Survey.

Abstract

In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers.