Ethical Dilemma with Stakeholders
You're the CEO of a pharmaceutical company. Your best-selling drug ($2B annual revenue, used by 4 million patients for chronic pain) has…
As CEO, I would not wait six months and I would not let the board delay disclosure while patients remain exposed to an unreported serious risk. I would treat this as a patient-safety, regulatory, legal, and trust crisis—not merely a financial-risk issue. My guiding decisions would be: Patient safety comes first.Read the full answer
Immediate Priorities Prioritize patient safety by initiating monitoring and reporting preparations, while assessing full data to inform board and regulators. Ethically and legally, liver failure qualifies as a serious adverse event requiring FDA expedited reporting within 15 days of awareness, as delays have led to…Read the full answer