Ethical Dilemma with Stakeholders

48-Hour CEO Action Plan: Balancing Patient Safety, Ethics, and Business Survival

Core Principles:

1. Patient safety overrides all other interests.
2. Transparency and proactive disclosure preserve long-term trust (regulatory, public, investor).
3. Legal/compliance obligations must be met, but not weaponized to delay ethical action.
4. Financial loss is inevitable, but reputational collapse is optional.

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Hour-by-Hour Plan (Starting 7:00 AM, Day 1)

Day 1 (Thursday)

7:00–8:00 AM: Emergency Leadership Huddle

• Attendees: CEO, CMO, Head of R&D, General Counsel, Chief Compliance Officer (CCO), CFO.
• Action: Confirm internal data accuracy (1 in 8,000 risk, 5-year exposure). CMO presents clinical context; R&D shares missing trial data.
• Decision: Proceed with immediate disclosure (no “waiting for more data”).

8:00–9:30 AM: Regulatory Pre-Notice

• Action: CCO drafts immediate FDA notification (per 21 CFR 314.80 for expedited safety reports). Use “15-day report” pathway for unexpected serious risks.
• Rationale: Voluntary disclosure undercuts later claims of concealment; FDA relationship preserved.

9:30–11:00 AM: Legal/PR War Room

• Action:
  • Legal: Prepare for class-action suits (estimate $5–10B liability). Retain external counsel (Williams & Connolly for defense; Goldman Sachs for financial restructuring).
  • PR: Draft “Patient Safety First” script for 72-hour earnings call (acknowledge risk, outline mitigation, no deflection).
• Rationale: Proactive legal strategy reduces punitive damages; PR must align with ethical stance.

11:00 AM–12:00 PM: Board Crisis Call

• Action: Present options:
  1. Disclose now (40% stock drop, but salvage trust).
  2. Delay (risk criminal charges, total collapse).
• Outcome: Vote to disclose. Dissenting board members offered resignation (to avoid leaks).

12:00–2:00 PM: Patient Safety Protocol

• Action:
  • Issue Dear Healthcare Provider letter (via email/fax to 200k prescribers) within 24 hours.
  • Update labeling via FDA “Changes Being Effected” (CBE-0) supplement (immediate liver enzyme monitoring).
  • Launch free liver function test program (partner with Quest Diagnostics).

2:00–4:00 PM: Employee Town Hall

• Action: CEO addresses global staff via Zoom. Script: “We are prioritizing patients over profits. No layoffs; R&D budget protected.”
• Rationale: Prevents internal leaks; retains talent.

4:00–6:00 PM: Investor Pre-Spin

• Action: CFO calls top 10 institutional investors (BlackRock, Vanguard) to pre-brief. Emphasize:
  • Risk is rare but real.
  • Cash reserves ($8B) cover liabilities.
  • Pipeline (3 Phase III drugs) unaffected.
• Rationale: Reduces panic selling; secures support for equity raise if needed.

6:00–8:00 PM: Regulatory Submission

• Action: Submit expedited FDA report via electronic gateway. Include:
  • Risk estimate (95% CI: 1/6,000–1/10,000).
  • Proposed label change (boxed warning).
  • Post-market surveillance plan.

8:00–10:00 PM: Media Prep

• Action: Prep CEO for Friday morning exclusive with STAT News (medical media credibility). Key message: “We are doing what Purdue Pharma failed to do—put patients first.”

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Day 2 (Friday)

7:00–8:00 AM: FDA Call

• Action: CEO + CCO join FDA emergency call. Propose joint public safety advisory (FDA + company) within 48 hours.
• Rationale: Shared messaging reduces FDA adversarial stance.

8:00–9:00 AM: Label Update

• Action: Submit CBE-0 supplement to FDA. New label: “Monitor ALT/AST every 3 months; discontinue if >3x ULN.”

9:00–10:00 AM: Board Meeting (In-Person)

• Action: Approve:
  • $500M reserve for patient compensation fund (no-fault claims).
  • Suspend share buybacks; freeze exec bonuses.
• Outcome: Unanimous vote (dissenters resigned).

10:00–12:00 PM: Earnings Call Script Finalized

• Action: CFO and CEO rehearse Q&A. Key points:
  • Q3 revenue impact: -$200M (returns/boxed warning).
  • 2024 guidance: No change (offset by pipeline growth).

12:00–1:00 PM: Patient Advocacy Outreach

• Action: CEO calls leaders of American Chronic Pain Association and Liver Foundation. Offer advisory board roles in safety program.

1:00–2:00 PM: Social Media Blackout

• Action: Pause all branded drug ads (Google, Facebook). Replace with safety PSA: “Talk to your doctor about liver monitoring.”

2:00–4:00 PM: Final Prep

• Action:
  • Legal files 8-K pre-earnings (disclose risk in “safe harbor” statement).
  • PR distributes FAQ for patients (translated to Spanish, Mandarin).

4:00–6:00 PM: Quiet Period

• Action: CEO and CFO incommunicado. Staff monitors stock/fallback plan if halted (Nasdaq circuit breaker).

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Earnings Call (Day 3, Saturday, 8:00 AM)

• Lead: “We discovered a rare liver risk. We are immediately updating labels, compensating affected patients, and working with FDA. This is the right decision, though painful financially.”
• Outcome: Stock drops 35% (not 40%), rebounds 5% by close (investor confidence in transparency).

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Post-48-Hour Actions

1. FDA joint press conference (Monday).
2. Launch Phase IV post-market study (10,000-patient registry).
3. Congressional testimony prep (inevitable).

CEO Quote to Board: “We can lose $2B in revenue, or we can lose $200B in value when the cover-up is exposed. Our duty is to the patients who trusted us.”