Day 1
Hour 1-2: Immediate Assessment and Information Gathering
- Objective: Gather all available data on the side effect, including the internal research report, patient case studies, and any existing literature.
- Reasoning: A comprehensive understanding of the situation is crucial for informed decision-making.
Hour 3-4: Assemble a Crisis Management Team
- Objective: Form a cross-functional team including legal, compliance, R&D, communications, and operations.
- Reasoning: A multidisciplinary approach ensures that all aspects of the issue are considered.
Hour 5-6: Legal and Ethical Review
- Objective: Consult with the legal team to understand the implications of immediate disclosure vs. waiting for more data.
- Reasoning: Balance legal obligations with ethical responsibilities to patients and shareholders.
Hour 7-8: Develop Preliminary Communication Strategy
- Objective: Work with PR and communications to draft internal and external messages. Prepare for potential media inquiries.
- Reasoning: Transparent communication can help manage public perception and maintain trust.
Hour 9-10: Board Member Briefing
- Objective: Conduct a briefing with board members to update them on the situation and outline the proposed action plan.
- Reasoning: Ensure alignment and prepare for the upcoming board meeting.
Hour 11-12: Consult Key Stakeholders
- Objective: Speak with key opinion leaders in the medical community and patient advocacy groups to gauge their perspectives.
- Reasoning: External insights can guide the decision-making process and enhance credibility.
Day 2
Hour 13-14: Scenario Planning and Risk Assessment
- Objective: Conduct a risk assessment for different scenarios, including immediate disclosure, waiting for more data, and potential regulatory responses.
- Reasoning: Anticipate the outcomes of each scenario to make a well-informed decision.
Hour 15-16: Draft Contingency Plans
- Objective: Prepare plans for dealing with potential fallout, including stock price impact, regulatory actions, and lawsuits.
- Reasoning: Being prepared can mitigate the impact of negative outcomes.
Hour 17-18: Finalize Board Meeting Presentation
- Objective: Prepare a presentation for the board meeting, including data, risks, and proposed actions.
- Reasoning: A clear presentation will facilitate decision-making and ensure all board members are informed.
Hour 19-20: Board Meeting Preparation
- Objective: Rehearse the presentation and anticipate board member questions and concerns.
- Reasoning: Being well-prepared enhances the credibility and effectiveness of the presentation.
Hour 21-22: Internal Communication
- Objective: Brief senior management and department heads to ensure they are informed and aligned.
- Reasoning: Consistent messaging across the company is crucial for maintaining employee morale and trust.
Hour 23-24: Board Meeting
- Objective: Present the situation, proposed actions, and seek board approval for the chosen course of action.
- Reasoning: The board's buy-in is essential for any significant decision affecting the company.
Next Steps Post-Board Meeting
- Immediate Disclosure: If the decision is to disclose immediately, prepare an official statement for regulatory bodies, investors, and the public. Update product warnings and inform healthcare professionals.
- Wait for More Data: If the decision is to wait, set a timeline for data collection and reassessment. Communicate the plan internally to maintain trust and transparency.
- Earnings Call Preparation: Adapt the earnings call script to address the issue honestly, focusing on the company's commitment to patient safety and regulatory compliance.
Considerations
- Legal Liability: Ensure that all actions comply with legal obligations and minimize the risk of future lawsuits.
- Ethical Obligations: Prioritize patient safety and transparency to maintain ethical standards.
- Financial Implications: Consider the long-term financial health of the company over short-term stock price fluctuations.
- PR Strategy: Develop a proactive communication strategy to manage public perception and maintain trust.
- Employee Morale: Keep employees informed to prevent misinformation and anxiety.
- Regulatory Relationships: Maintain open communication with regulators to demonstrate responsibility and cooperation.
This plan prioritizes patient safety and transparency while considering the company's legal and financial standing.