Ethical Dilemma with Stakeholders

48-Hour Action Plan as CEO

Core Guiding Principles for the Plan

• Patient Safety: Paramount. 4M patients on drug; 1-in-8,000 risk means ~500 annual liver failures if unaddressed. Delaying disclosure endangers lives and invites preventable harm.
• Legal Liability: FDA requires adverse event reporting within 15 days for serious events (21 CFR 314.80); full validation may take time, but "formal" 6-month process likely refers to label change approval. Hiding data risks criminal charges (e.g., wire fraud, 18 USC §1343), massive fines (e.g., $1B+ like Purdue Pharma), and shareholder suits. Immediate transparency minimizes liability.
• Ethical Obligations: Hippocratic "do no harm"; fiduciary duty to patients/shareholders outweighs short-term gains.
• Financial Implications: 40% stock drop (~$X billion loss, assuming $5B market cap) hurts, but non-disclosure could lead to 80-100% wipeout + bans (e.g., Vioxx precedent: $4.85B settlement). Long-term: Builds trust for pipeline.
• PR Strategy: Proactive, empathetic disclosure frames us as responsible leader; spin delay as "new data review."
• Employee Morale: Swift action shows integrity; secrecy breeds leaks/toxicity.
• Regulatory Relationships: Early voluntary report preserves goodwill vs. adversarial probe.
• Overarching Decision: Accelerate data validation; voluntarily report to FDA within 24 hours (faster than legal's 6 months via expedited channel); seek board buy-in for phased public disclosure pre-earnings call. No suppression—board dissenters overruled by CEO authority if needed.

Hour-by-Hour Plan (Starting now at Hour 0; assumes 24/7 crisis mode with on-call execs. All meetings virtual/in-person at HQ with NDAs refreshed.)

Hours 0-2: Immediate Crisis Team Assembly & Data Lockdown (10 PM - Midnight)

• Actions:
  1. Call emergency meeting (Zoom + HQ war room): Me (CEO), CSO (Chief Scientific Officer), CLO (Chief Legal Officer), CMO (Chief Medical Officer), CFO, Head of Pharmacovigilance, Head of Regulatory Affairs, Head of PR/Comms. (Prep: 30-min heads-up texts with "Code Red: Safety Signal.")
  2. Issue company-wide "data freeze" memo: No external sharing of research findings; internal audit trail for all related docs.
  3. Direct Pharmacovigilance to pull all post-market data (VAERS, claims databases) for real-time analysis.
• Reasoning: Establishes command center for coordinated response. Data lockdown prevents leaks (financial/PR risk) while enabling audit-proof transparency (legal). Early quant of risk (beyond 1:8K) informs decisions; boosts morale via leadership visibility.

Hours 2-6: Deep-Dive Internal Assessment (Midnight - 4 AM)

• Actions:
  1. CSO/CMO-led review: Re-analyze trials/post-market data; model incidence (e.g., 5-year cumulative risk); assess causality (e.g., Bradford Hill criteria); ID at-risk patients (e.g., via genomics?). Target: Preliminary risk summary report by Hour 6.
  2. CLO/Regulatory Head: Map fastest FDA path—file expedited "Field Alert Report" (21 CFR 314.81) + MedWatch Form 3500A tonight if signal confirmed; prep EU EMA parallel. Challenge "6-month" timeline: Push for 15-day serious AE report.
  3. CFO: Run financial models—disclosure scenarios (40% drop = $X loss; vs. scandal = 70% + $Y legal).
• Reasoning: Validates signal independently (ethics/safety); accelerates regulatory path (legal—avoids willful delay charges). Quant models de-risk board pitch (finance); night hours minimize disruptions.

Hours 6-10: External Expert Validation & Patient Safety Triage (4 AM - 8 AM)

• Actions:
  1. CLO coordinates 2-3 independent hepatologists/KOLs (pre-vetted, NDA'd) for 2-hour consult: Blind review of data; advice on monitoring/mitigation (e.g., LFT screening protocol).
  2. CMO: Activate "Patient Safety Protocol"—flag high-risk profiles in our registry; draft physician letters for interim monitoring (no recall yet). Notify top 10 sales reps for informal MD alerts.
  3. PR Head: Draft holding statements; monitor social/competitor chatter for leaks.
• Reasoning: Third-party validation strengthens credibility (regulatory/PR); interim safety steps protect patients immediately (ethics) without alarming public prematurely (finance/morale). Builds defensible record (legal).

Hours 10-14: Legal/Financial War Gaming & Board Prep (8 AM - Noon)

• Actions:
  1. Full team debrief: Approve FDA expedited filing (submit by Hour 14 if signal holds).
  2. CFO/CLO: Scenario planning—best/worst case liabilities (e.g., $500M settlements fundable via insurance).
  3. Me + CLO + PR: Prep board deck—data, risks, "Transparent Path Forward" (disclose voluntarily, pause new scripts, pipeline pivot). Rehearse responses to "wait for data" pushback (e.g., "Delay = felony risk").
  4. Employee all-hands memo (internal only): "Reviewing safety signal; your diligence key—stay focused."
• Reasoning: Preps board dominance (finance—quantify hiding costs 2x disclosure); filing FDA now starts clock favorably (legal/regs). Morale memo prevents panic.

Hours 14-24: Board Meeting & FDA Submission (Noon Day 1 - Noon Day 2)

• Actions:
  1. Hour 14-16 (10 AM- Noon Day 1): Board meeting (in-person/hybrid). Present deck; vote on disclosure plan. If 3 dissent, invoke CEO tie-breaker + bylaws authority.
  2. Hour 16-20: Post-board: Finalize/submit FDA report (with KOL endorsements). Notify key regulators (e.g., phone EMA).
  3. Hour 20-24: Comms dry-run; draft earnings call script—"Proactively addressing new data; patient safety #1; details in 8-K." Alert investor relations for after-hours prep.
• Reasoning: Board first respects governance (finance/morale) but CEO leads ethically. FDA submit locks in compliance (legal/safety/regs); scripted comms control narrative (PR).

Hours 24-36: PR Ramp-Up & Stakeholder Alignment (Noon Day 2 - Midnight Day 2)

• Actions:
  1. PR/Investor Relations: File SEC 8-K (material event) post-FDA submit; prep press release ("Voluntary update on rare AE; enhanced monitoring").
  2. CMO: Roll out physician alerts (e-mail/fax: "Monitor LFTs q3mo"); patient registry push for check-ins.
  3. CLO: Engage crisis counsel (e.g., top pharma litigators) for suits prep; insurance notifications.
  4. All-hands virtual town hall: Transparent update (no specifics to avoid panic); Q&A.
• Reasoning: Phased comms softens stock hit (finance/PR—proactive = +rebound); safety actions save lives (ethics); town hall boosts morale.

Hours 36-48: Earnings Call Final Prep & Execution (Midnight Day 2 - 10 PM Day 3)

• Actions:
  1. Hour 36-40: Rehearse earnings call (script: Lead with disclosure, empathy, mitigation, pipeline positives).
  2. Hour 40-44: Monitor markets/FDA feedback; tweak PR (e.g., patient support hotline launch).
  3. Hour 44-48: Earnings call (72-hour mark). Post-call: Analyst briefings; board follow-up memo.
  4. Ongoing: Daily safety metrics dashboard.
• Reasoning: Transparent call rebuilds trust (PR/finance—Vioxx taught us opacity kills); hotline shows care (ethics/morale). Positions for recovery (regs supportive of candor).

Expected Outcomes: Stock dips 20-30% (less than 40% via proactive spin); lawsuits filed but winnable/settleable; lives saved via monitoring; company emerges stronger. If board blocks, resign publicly (personal ethics). This plan balances all factors—safety/legal first, averting catastrophe.