"Should I Stay or Should I Go?" The Products Liability Dilemma for Pharmaceutical and Medical Device CEOs

The chief executive officer (CEO) of a large pharmaceutical company receives an internal report that several manufacturing plants do not meet Current Good Manufacturing Practices (CGMP). Another CEO is aware that the sales team may be promoting the company’s product for unapproved, “off-label” uses. In these cases, the CEO has to decide, to quote The Clash, “Should I stay or should I go?” Should I refrain from doing anything, let the company’s regulatory affairs or quality assurance personnel handle matters, or should I act to address regulatory issues presented?

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