48-Hour Action Plan: CEO Response to Drug Safety Crisis

Day 1

Hours 1-3: Immediate Assessment & Response Team Assembly

I'll immediately convene an emergency meeting with our internal research team, Chief Medical Officer, Chief Scientific Officer, and head of Pharmacovigilance to fully understand the liver failure findings.

Reasoning: Patient safety is my paramount concern. With 4 million users and a 1:8,000 risk, approximately 500 people could suffer liver failure over 5 years. Every day of delay potentially puts more patients at risk.

Hours 4-6: Legal & Regulatory Consultation

Meet with Chief Legal Officer, Chief Compliance Officer, and engage specialized outside counsel to challenge the 6-month reporting timeline.

Reasoning: The 6-month timeline seems excessive for a serious safety issue. Most regulatory bodies have expedited pathways for reporting significant safety concerns. I need to understand all legal obligations while seeking the fastest possible disclosure route.

Hours 7-9: Financial Impact Analysis

Work with CFO to model multiple disclosure scenarios including stock impact, litigation costs, and long-term financial implications.

Reasoning: While the 40% stock drop is concerning, the financial and legal consequences of concealment would likely be catastrophic in the long term. I need precise models to present to the board.

Hours 10-12: Patient Safety Protocol Development

Direct Medical Affairs to develop:

• Physician guidance for monitoring patients
• Patient communication materials
• Liver function testing recommendations
• Support resources for potentially affected patients

Reasoning: We must develop actionable safety protocols that can be implemented immediately after disclosure to minimize harm.

Hours 13-16: Communication Strategy Development

Work with PR, Investor Relations, and Legal teams to draft:

• Regulatory submissions
• Press releases
• "Dear Healthcare Provider" letter
• Investor communications
• Internal employee messaging

Reasoning: Transparent, consistent messaging across all channels demonstrates responsibility and protects the company's reputation. These materials must balance transparency with appropriate context.

Hours 17-20: Individual Board Member Outreach

Schedule one-on-one calls with each board member, starting with the three advocating delay.

Reasoning: I need to understand their concerns while clearly communicating why immediate disclosure is both ethically necessary and legally required. Individual conversations allow for frank discussion without group dynamics and build consensus before the formal meeting.

Hours 21-24: Board Presentation Preparation

Finalize comprehensive board materials including:

• Full scientific findings with validation methods
• Legal analysis of disclosure requirements and liability risks
• Financial impact models for various scenarios
• Patient safety plan
• Communications strategy
• Regulatory submission timeline

Reasoning: The board needs complete information to fulfill their fiduciary duties. The presentation must be thorough and compelling to overcome short-term financial concerns.

Day 2

Hours 25-28: Earnings Call Preparation

Work with IR and Legal to prepare:

• Updated earnings script incorporating safety disclosure
• Q&A preparation for difficult questions
• Supporting materials explaining context

Reasoning: The earnings call must present a unified message that demonstrates responsible leadership while providing appropriate context for the safety finding.

Hours 29-32: Implementation Planning

Develop 30/60/90-day action plans for:

• Regulatory engagement
• Healthcare provider education
• Patient monitoring program
• Investor relations activities
• Long-term product strategy

Reasoning: Showing a clear path forward demonstrates leadership and helps mitigate stock impact by focusing on future problem resolution.

Hours 33-36: Executive Team Alignment

Host a comprehensive alignment session with the full executive team to:

• Ensure unified understanding of approach
• Address any remaining concerns
• Assign specific responsibilities for disclosure execution
• Prepare for various board meeting outcomes

Reasoning: Unity among the executive leadership is essential. We need to present a cohesive front regardless of personal concerns about stock impact or career implications.

Hours 37-40: Legal Safeguarding

Work with legal counsel to:

• Document all decision-making processes
• Preserve all relevant communications and data
• Implement litigation preparedness measures
• Prepare for potential regulatory investigations

Reasoning: Proper documentation of our disclosure decision process protects the company and individual officers against future claims of negligence or concealment.

Hours 41-44: Final Preparation and Rehearsal

Conduct comprehensive rehearsals for:

• Board presentation
• Potential challenging questions from directors
• Media interviews
• Healthcare provider communications
• Earnings call

Reasoning: Thorough preparation ensures clear, consistent delivery across all channels and builds confidence in our approach.

Hours 45-48: Personal Preparation and Final Review

• Review all materials
• Consult with trusted external advisors
• Mental preparation for difficult conversations
• Personal reflection on ethical leadership

Reasoning: As CEO, my personal conviction and ethical leadership will set the tone. I must be prepared to stand firm on patient safety principles even if it means risking my position.

Key Decision Principles

1. Patient safety outweighs financial concerns - We cannot justify withholding information that could prevent serious harm.

2. Transparency builds trust - Our long-term success depends on maintaining trust with patients, providers, regulators, and investors.

3. Legal and ethical obligations align - Prompt disclosure fulfills both our regulatory requirements and ethical responsibilities.

4. Short-term pain vs. long-term catastrophe - A 40% stock drop now is preferable to the existential threat posed by concealment.

5. Disclosure is inevitable - In today's world with whistleblowers and heightened surveillance, this information will eventually become public. Managing disclosure proactively is the only viable strategy.

I will recommend immediate disclosure to regulators, followed by coordinated communication to healthcare providers and the public, regardless of short-term financial impact. This approach best serves our patients, preserves our company's integrity, and protects long-term shareholder value.