Ethical Dilemma with Stakeholders

In the next 48 hours, my primary objective is to balance the company's legal, ethical, and financial responsibilities while prioritizing patient safety. Here's my hour-by-hour action plan:

Hours 1-2: Gather Information and Assess the Situation

• Meet with the internal research team to understand the study that identified the rare side effect, the methodology used, and the confidence level of their findings.
• Review the clinical trial data and post-marketing surveillance reports to assess the validity of the research team's findings.
• Discuss with the legal team the regulatory requirements for reporting the side effect, the potential consequences of delayed reporting, and the risks associated with disclosure.

Hours 3-6: Internal Communication and Preparation

• Inform key stakeholders within the company, including senior executives, the head of R&D, and the head of regulatory affairs, about the potential side effect and the impending board meeting.
• Prepare a comprehensive briefing document for the board meeting, including the research findings, potential implications, and recommended courses of action.
• Develop a draft press release and Q&A document in anticipation of potential disclosure.

Hours 7-12: Board Meeting Preparation

• Finalize the board meeting agenda, focusing on the rare side effect and the recommended course of action.
• Prepare a presentation for the board meeting, highlighting the key findings, potential risks, and benefits of disclosure.
• Anticipate and prepare responses to potential questions from the board members, particularly those pushing to "wait for more data."

Hours 13-24: Board Meeting and Decision

• Attend the board meeting and present the findings and recommendations.
• Engage in a thorough discussion with the board members, addressing their concerns and providing additional information as needed.
• Based on the discussion, make a decision on whether to disclose the information to regulatory agencies and the public. If the decision is to disclose, instruct the team to prepare for an expedited regulatory report and a public announcement.

Hours 24-36: Regulatory Engagement and Disclosure Preparation

• If the decision is to disclose, immediately notify the relevant regulatory agencies (e.g., FDA) and initiate the expedited reporting process.
• Work with the regulatory team to prepare the necessary documentation and notifications.
• Refine the press release and Q&A document based on the board's feedback and the regulatory requirements.

Hours 37-48: Final Preparations

• Review and finalize the press release, Q&A document, and other communication materials.
• Prepare a statement for the upcoming earnings call, addressing the disclosure and its potential impact on the company's financials.
• Ensure that all relevant teams, including investor relations, PR, and customer support, are informed and prepared for the disclosure and potential inquiries.

Rationale and Considerations:

1. Patient Safety: Disclosure of the rare side effect is essential to ensure that patients and healthcare providers are aware of the potential risks. This decision prioritizes patient safety and adheres to the company's ethical obligations.
2. Regulatory Compliance: Expedited reporting to regulatory agencies is necessary to comply with regulatory requirements and minimize potential liability.
3. Financial Implications: While disclosure may lead to a short-term stock price drop, transparency and proactive management of the issue can help maintain investor trust in the long run.
4. PR Strategy: A well-planned disclosure and communication strategy can help mitigate the negative impact on the company's reputation.
5. Employee Morale: By prioritizing transparency and patient safety, the company demonstrates its commitment to ethical business practices, which can positively impact employee morale.
6. Board Dynamics: Engaging with the board members and addressing their concerns can help build trust and ensure a unified decision.

By following this action plan, the company can make an informed decision, prioritize patient safety, and prepare for the potential consequences of disclosure, ultimately maintaining its reputation and long-term sustainability.