Compliance into the Weeds is the only weekly podcast which takes a deep dive into a compliance related topic, literally going into the weeds to more fully explore a subject. In this episode, Matt Kelly and I go into the weeds to explore the recent SEC enforcement action against Mylan and its mischaracterization of the drug EpiPen as a generic drug. This mischaracterization cost the federal government millions of dollars and led the SEC to fine Mylan $30MM.
Some of the highlights include:
- How can one event have multiple risk scenarios?
- How risks can ripple across an organization?
- Who oversees risk for a company in a holistic manner?
- How can internal controls help to break down silos?
- Where was compliance?
- Why do internal controls need to cut across silos to provide (at least) internal transparency?
For additional reading see the following:
Matt’s blog post, Mylan’s Lessons on Silos & Risks, on Radical Compliance.