Draft Compliance Guidance
This article was originally published in SRA
Executive Summary
Voluntary measures for pharmaceutical manufacturers to combat fraud
Voluntary measures for pharmaceutical manufacturers to combat fraud
As part of an initiative to engage the healthcare community in preventing and reducing fraud and abuse in federal healthcare programmes, the US Office of Inspector General (OIG) has drafted a guidance document that sets out the fundamental principles of internal compliance programmes for pharmaceutical manufacturers1. The guidance suggests that the following elements need to be considered when developing and implementing an effective compliance programme:
- implementing written policies and procedures i.e. a code of conduct;
- designating a compliance officer and recruiting a compliance committee with authority to report directly to the board of directors and/or the president or CEO;
- conducting effective training and education for all employees who are affected;
- developing effective lines of communication, such as a hotline or other reporting system, and adopting procedures to protect anonymity of complainants;
- conducting internal monitoring and auditing to identify and reduce problems;
- enforcing standards through well-publicised disciplinary guidelines; and
- responding promptly to detected problems and undertaking corrective action.
With this guidance document the OIG hopes to promote adherence to applicable statutes, regulations and requirements of the federal healthcare programmes (i.e. any plan or programme that provides health benefits and is funded in whole or in part by the US government). Comments on the proposed guidance were requested by 2 December 2002.
References
1. Federal Register , 3 October 2002, 67 (192), 62057-62067