Compliance Challenges within Medical Affairs

Source: Policy and Medicine; June 2014

As the responsibilities of Medical Affairs professionals continue to evolve, it is paramount that we stay informed about how changes may impact our profession. In many companies, compliance is now a key responsibility within Medical Affairs departments. Although no statutory requirements exist, since 2004, several corporate integrity agreements (CIAs) have included language that reinforces the importance of the medical affairs function as a compliance tool. In 2014, Policy and Medicine posted an article that recapped findings from the Second Annual Summit on The Evolving Role of Medical Affairs and Thought Leader Engagement in an Era of Transparency, summarizing the fines that were imposed on several companies for compliance failures—totaling over $6 million from 2009-2012. It also reinforces some of the key areas that we, as Medical Affairs professionals, should keep in mind. Although the data are a few years old, the messages are current, and should be kept in mind as we move our profession forward.

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