48-Hour Crisis Action Plan

Hours 1-4: Immediate Assessment & Team Assembly

1:00 AM - 3:00 AM:

• Contact my most trusted external crisis counsel (not our usual firm - potential conflicts)
• Summon head of R&D, Chief Medical Officer, and Head of Regulatory Affairs immediately
• Secure all internal research documents and communications about the finding

Reasoning: Need independent legal advice and core team assembled before any decisions that could create precedent

3:00 AM - 4:00 AM:

• Review the raw data personally with CMO - verify the finding, timeline, and methodology
• Document everything in writing with timestamps

Hours 5-12: Stakeholder Mapping & Legal Framework

5:00 AM - 8:00 AM:

• Brief external counsel on findings, request immediate analysis of safe harbor provisions and mandatory reporting timelines
• Contact the FDA's Center for Drug Evaluation contact person directly (use personal relationship)
• Begin drafting preliminary physician communication

Reasoning: FDA expects good faith efforts to protect public health; early engagement shows responsible behavior

8:00 AM - 12:00 PM:

• Schedule emergency board meeting for 24 hours out (not 48) with essential information only
• Inform head of IR/Communications to begin stakeholder notification preparation
• Contact largest institutional investors personally to brief them privately

Hours 13-24: Communication Strategy & Patient Safety

13:00 PM - 16:00 PM:

• Issue immediate letter to prescribing physicians recommending enhanced liver function monitoring for high-risk patients
• Submit preliminary adverse event report to FDA (even if incomplete)
• Prepare patient hotline and medical information resources

Reasoning: Patient safety is non-negotiable. Enhanced monitoring can prevent deaths while we work through regulatory process

16:00 PM - 20:00 PM:

• Brief key medical societies and patient advocacy groups
• Finalize investor relations approach - prepare for stock impact
• Begin crafting public statement emphasizing patient safety first

20:00 PM - 24:00 PM:

• Hold emergency board session (small group, focused discussion)
• Present three options: immediate full disclosure, phased disclosure with enhanced monitoring, or wait for complete regulatory package
• Vote on approach with clear documentation of decision rationale

Hours 25-36: Implementation & Market Preparation

25:00 PM - 30:00 PM:

• Execute chosen disclosure strategy
• If immediate: file full adverse event reports, issue press release, hold investor call
• If phased: implement physician outreach + enhanced monitoring program
• Activate crisis communications team

30:00 PM - 36:00 PM:

• Monitor market reaction and patient calls to physician offices
• Brief major insurance companies and formulary committees
• Prepare SEC filing for earnings call

Hours 37-48: Damage Control & Forward Planning

37:00 PM - 42:00 PM:

• Hold analyst call explaining decision-making process and patient safety measures
• Address media inquiries with consistent messaging
• Assess need for additional supply chain adjustments

42:00 PM - 48:00 PM:

• Prepare earnings call materials acknowledging impact but emphasizing responsible leadership
• Brief sales force on new protocols and Q&A
• Finalize enhanced patient monitoring program rollout

Core Decision Framework

Primary Principle: Patient safety above all else. The 1-in-8,000 risk represents ~500 patients at risk annually - this cannot be treated as a business problem.

Risk Mitigation:

• Early FDA engagement provides safe harbor protection
• Enhanced monitoring reduces actual patient harm during transition period
• Transparent communication with investors prevents securities issues
• Professional medical community briefing ensures appropriate patient care

Expected Outcomes:

• Stock drop of 25-30% (vs. 40% + litigation risk from delayed disclosure)
• Stronger regulatory relationship due to proactive approach
• Reduced liability exposure through good faith safety efforts
• Preservation of long-term company reputation

The alternative - waiting - risks patient deaths that could result in criminal liability, massive litigation, and complete collapse of stakeholder trust. As CEO, I'd rather face financial consequences than potential manslaughter charges.