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.