ABSTRACT
I was recently talking with the CEO of one of the world’s largest pharmaceutical companies and he asked me, “How did this happen?” The “this” was an FDA injunction, potentially a corporatewide injunction. My answer to the question required considerable diplomacy, because in looking at the company’s history, all the signs of impending regulatory doom were clearly apparent. This very sophisticated company and its most senior manager, however, were unaware of what got them where they were.
