48-Hour Crisis Action Plan

Hours 1-6: Immediate Response Team Assembly

Action: Convene emergency leadership team (Medical Affairs, Legal, Regulatory, PR, Compliance, Finance heads) Reasoning: Need comprehensive expertise to assess situation properly before board meeting

Key tasks:

• Legal team prepares preliminary liability assessment
• Medical Affairs quantifies patient risk and identifies affected population
• Regulatory team outlines reporting requirements and timelines
• PR begins drafting communication frameworks

Hours 6-12: Evidence Review and Risk Assessment

Action: Analyze all available data on the side effect - incidence rates, patient profiles, severity, treatment options

Decision framework development:

• Risk to patients vs. financial/business impact
• Legal obligations vs. board pressure
• Ethical duties to current patients vs. future patients

Reasoning: Cannot make informed decisions without understanding the true scope. The 1:8,000 rate over 5 years affects ~500 patients annually - this is not negligible.

Hours 12-18: Stakeholder Mapping

Action: Identify key stakeholders and their likely responses:

• Patients/Caregivers: Need immediate information to make informed decisions
• Physicians: Require guidance on patient monitoring and alternatives
• Regulators: Expect prompt reporting regardless of business impact
• Investors: Will react negatively but prefer honest leadership
• Employees: Want to work for an ethical company

Reasoning: Understanding stakeholder dynamics helps prioritize actions and craft appropriate messaging.

Hours 18-24: Communication Strategy Development

Action: Prepare multi-tiered communication approach:

Immediate (within 24 hours):

• Internal memo to employees acknowledging situation
• Physician letter template with interim guidance
• Regulatory reporting draft

48-72 hour window:

• Public disclosure before earnings call
• Patient notification system activation

Reasoning: Proactive, transparent communication builds trust and demonstrates leadership, even when painful.

Hours 24-30: Board Meeting Preparation

Action: Prepare comprehensive presentation covering:

1. Medical facts: Unbiased presentation of risk data
2. Legal obligations: Clear regulatory requirements and timelines
3. Ethical imperative: Our duty to patients above all
4. Business case: Short-term pain vs. long-term reputation/costs
5. Action plan: Specific steps for next 72 hours

Strategic approach: Present this as a fait accompli - we WILL report, the only question is timing and approach.

Reasoning: Board members pushing to wait need education on real stakes. Preparing them prevents later resistance.

Hours 30-36: Pre-emptive Actions

Action: Execute several steps before board meeting:

1. Begin regulatory reporting process - contact FDA/EMA to demonstrate good faith effort
2. Activate physician communication - medical affairs team begins reaching out to key prescribers
3. Internal communication - employees deserve to hear from leadership first
4. Legal documentation - ensure all actions are properly recorded

Reasoning: Demonstrates decisive leadership and makes reversal politically difficult for board members.

Hours 36-42: Board Meeting

Action: Present case for immediate action with moral clarity:

Key arguments:

• "We didn't catch this in trials, but we caught it now - that's our strength, not weakness"
• "Every day we delay puts more patients at risk"
• "Our reputation for integrity is our most valuable asset"
• "Markets punish deception far more than honesty"

Decisions to secure:

• Authorization for immediate regulatory reporting
• Approval for physician/patient communication
• Support for earnings call transparency

Reasoning: Board meeting becomes moment of truth for company values.

Hours 42-48: Pre-Earnings Call Preparation

Finalize communications:

1. Regulatory submission - file preliminary report demonstrating good faith
2. Physician outreach - deploy medical science liaisons with updated safety information
3. Patient communication plan - direct mail/email system for current users
4. Earnings call script - transparent but strategic messaging

Key messaging framework:

• Acknowledge oversight in clinical trials
• Emphasize proactive identification and response
• Outline patient safety measures being implemented
• Discuss business impact honestly but with long-term perspective

Stock price management:

• Signal commitment to patient safety as core value
• Outline mitigation strategies for business impact
• Demonstrate strong leadership through crisis

Critical Decision Points:

Why not wait for "more data" as board members suggest?

• Risk to patients is real and ongoing
• Regulatory reporting is legally mandated regardless of data completeness
• Delay increases liability exposure exponentially
• Market eventually discovers cover-ups, destroying trust permanently

Why act before board meeting?

• Demonstrates leadership capability
• Makes ethical action inevitable
• Protects patient safety above political considerations
• Builds internal support for decision

Expected Outcomes:

Short-term (1-3 months):

• Stock price decline of 25-35% (better than 40% surprise drop)
• Increased regulatory scrutiny
• Some patient discontinuation of medication

Long-term benefits:

• Enhanced reputation for integrity
• Stronger physician trust and relationships
• Reduced legal liability exposure
• Improved employee morale and retention
• Better regulatory relationship through transparency

Key Principle:

In pharmaceuticals, patient safety cannot be balanced against business interests - it must be the foundation upon which business decisions are made. Companies that demonstrate this principle consistently outperform those that don't over the long term, despite short-term volatility.

The next 48 hours will define not just this crisis response, but the character of the company for decades to come.