48-Hour Crisis Action Plan

HOUR 0-2: Immediate Containment & Fact Verification

Actions:

• Convene emergency meeting with Chief Medical Officer, General Counsel, Head of Regulatory Affairs, and Chief Scientific Officer
• Demand written summary of findings: statistical confidence, causality assessment, comparison to baseline liver failure rates
• Isolate all related data with legal privilege protection
• Implement document preservation protocol

Reasoning: Before any decision, I need to verify this isn't preliminary noise. However, I'm proceeding on assumption the finding is real—the stakes are too high for wishful thinking.

HOUR 2-4: Assemble Crisis Team

Actions:

• Activate crisis management protocol (should exist for exactly this scenario)
• Brief CFO on financial scenarios
• Engage external crisis PR firm with pharmaceutical experience
• Retain outside regulatory counsel (separate from company lawyers)
• Schedule individual calls with each board member before the meeting

Reasoning: I need independent expertise, not just internal voices with conflicts of interest. The board members pushing to "wait" need to understand the legal and ethical jeopardy immediately.

HOUR 4-8: Deep Medical Assessment

Actions:

• CMO leads team to:
  • Calculate exact risk: 1 in 8,000 over 5 years = ~500 patients from current user base
  • Compare to disease burden (chronic pain) and alternative treatments
  • Identify if any patient subpopulations are at higher risk
  • Determine if monitoring protocols could mitigate risk
  • Review if this changes benefit-risk calculus

Reasoning: 1 in 8,000 is serious but context matters. This drug serves 4 million patients. If alternatives are less effective or have worse side effects, the ethical calculation changes. I need data to make an informed decision, not just panic.

HOUR 8-12: Legal Reality Check

Actions:

• General Counsel and outside counsel provide written analysis:
  • Regulatory obligations timeline (spoiler: it's NOT 6 months for serious safety signals)
  • Criminal liability exposure for delay
  • Civil liability scenarios (failure to warn vs. proper disclosure)
  • Securities law implications (material non-public information)
  • Discovery implications if we wait

Reasoning: My legal team saying "6 months" is either incompetent or motivated by stock price concerns. FDA requires reporting of serious, unexpected adverse events within 15 days. We're already on the clock. Waiting exposes me personally to criminal charges.

HOUR 12-16: Decision Point

My Decision: Immediate Disclosure Path

The "wait for more data" option is off the table. Here's why:

1. Legal: We have material safety information. Not reporting to FDA immediately violates federal law. Trading on our stock (or allowing others to) with this knowledge is securities fraud.

2. Ethical: 500 patients may develop liver failure. Every day of delay while people start new prescriptions is indefensible.

3. Practical: Leaks are inevitable. Better to control the narrative than have it exposed.

4. Fiduciary: The board members pushing delay are exposing the company to catastrophic liability. A 40% stock drop is better than bankruptcy from criminal charges and civil suits.

Actions:

• Inform board individually: we're reporting to FDA within 24 hours
• Make clear: any director who objects should resign now or face potential personal liability
• Begin drafting FDA safety report
• Prepare for accelerated public disclosure

Reasoning: This is a "jump or be pushed" moment. The only question is whether we look responsible or reckless.

HOUR 16-24: Regulatory Notification

Actions:

• File 15-day safety report with FDA
• Request emergency meeting with FDA within 72 hours
• Propose solutions:
  • Enhanced liver function monitoring protocol
  • Updated black box warning
  • Dear Doctor letter to all prescribers
  • Patient notification program
  • Funded independent safety study

Reasoning: Coming to FDA with solutions, not just problems, demonstrates good faith. They're going to mandate changes anyway—better to propose reasonable ones first.

HOUR 24-30: Patient Safety First

Actions:

• Develop patient communication:

  • Direct mail to all identifiable patients (via pharmacy networks)
  • Website updates with clear risk information
  • Hotline for patient questions staffed by medical professionals
  • Free liver function testing for current users

• Update prescribing information immediately

• Brief major pharmacy chains

Reasoning: Patients are stakeholders, not just revenue sources. Direct communication reduces panic and shows we prioritize safety. It also creates legal protection (proper warning).

HOUR 30-36: Prepare Board & Investors

Actions:

• Circulate board memo outlining:

  • The medical findings
  • Legal obligations
  • Actions already taken
  • Financial scenarios
  • Why delay was never an option

• Prepare for board meeting with:

  • Outside counsel present
  • Clear resolution to approve disclosure plan
  • Director & Officer insurance review

• Draft 8-K filing for SEC

• Prepare earnings call script with full disclosure

Reasoning: The board meeting needs to be a formality, not a debate. I've already made the legally required decisions. They can fire me, but they can't stop regulatory reporting.

HOUR 36-42: Communications Strategy

Actions:

• Prepare multi-channel communications:

  • Press release emphasizing patient safety priority
  • Video statement from me (CEO) explaining situation
  • Detailed Q&A document
  • Talking points for all executives
  • Employee town hall

• Key messages:

  • "We discovered this through our ongoing safety monitoring"
  • "Patient safety is our first priority"
  • "We're working closely with FDA"
  • "The drug remains beneficial for millions, but patients deserve full information"
  • "We're implementing enhanced monitoring"

Reasoning: Control the narrative. Emphasize proactive discovery and responsible action. Acknowledge the seriousness without catastrophizing.

HOUR 42-46: Employee Communication

Actions:

• All-hands meeting (virtual) before any public announcement
• Explain situation honestly
• Emphasize: "This is how responsible companies operate"
• Prepare for morale impact and potential departures
• Reassure about company's long-term viability

Reasoning: Employees will hear about this. Better from me first. They need to believe we did the right thing, or we'll lose our best people.

HOUR 46-48: Final Preparations

Actions:

• Board meeting: Present fait accompli, get formal approval
• Finalize all communications
• Coordinate timing: 8-K filing, press release, FDA notification all synchronized
• Brief investor relations on expected questions
• Prepare for earnings call with full transparency

Reasoning: Execution matters. Simultaneous, coordinated disclosure prevents information arbitrage and shows control.

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THE BOARD MEETING (Hour 48)

My Opening Statement:

"Directors, we have a legal and ethical obligation to report this immediately. I've already initiated FDA notification. You can support this decision or replace me, but you cannot stop it. Our legal counsel will now explain why delay would expose each of you to personal liability for knowing violation of federal law.

The stock will drop. That's unfortunate. Bankruptcy from criminal prosecution and failure-to-warn lawsuits would be catastrophic. We're taking the responsible path.

I need your approval for the patient notification program and the communications strategy. The medical data will be published regardless—the question is whether we lead or follow."

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EARNINGS CALL (Hour 72)

My Statement:

"Before discussing quarterly results, I need to address a patient safety matter. Our ongoing monitoring identified a rare but serious side effect that wasn't apparent in clinical trials. We immediately reported to FDA and are notifying all patients and physicians.

This drug has helped millions of people. The risk is real but small, and we believe with proper monitoring, the benefits still outweigh the risks for most patients. We're committed to full transparency and patient safety.

This will impact revenue. We estimate [realistic number]. But our obligation is to patients first, shareholders second. Companies that prioritize short-term stock price over safety don't survive long-term.

I'm proud of our team for identifying this and our company for responding correctly. Now, let me turn to our quarterly results..."

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WHY THIS APPROACH

Legal Protection:

• Demonstrates good faith and compliance
• Creates record of prioritizing safety
• Minimizes criminal exposure
• Reduces punitive damages in civil cases

Ethical Obligation:

• 500 potential liver failure cases is not acceptable collateral damage
• Patients can't make informed decisions without information
• Medical professionals need to monitor appropriately

Financial Reality:

• 40% stock drop is painful but survivable
• Criminal prosecution and massive civil liability could destroy the company
• Insurance companies won't cover knowing violations
• Reputation damage from cover-up far exceeds disclosure damage

Long-term Viability:

• Companies that handle crises transparently recover
• Companies that cover up (see: Vioxx, Purdue Pharma) face existential threats
• Employee retention requires ethical leadership
• Regulatory relationships matter for future products

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WHAT I'M BETTING ON

1. The drug still has value: 1 in 8,000 is serious but may be acceptable with monitoring for patients who benefit

2. Honesty is priced in faster: Markets hate uncertainty more than bad news

3. We avoid the death spiral: Cover-up → leak → panic → investigation → bankruptcy

4. We keep our best people: Talented employees don't want to work for criminals

5. FDA works with us: Regulators appreciate cooperation and punish deception

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THE HARD TRUTH

Those three board members pushing to "wait for more data" are either:

• Financially motivated (stock holdings)
• Legally naive (don't understand reporting requirements)
• Ethically compromised (willing to risk patient lives)

None of those is acceptable. If they push back hard, I'll ask for their resignation. A CEO's job is to make hard decisions that protect the company long-term, even when they're painful short-term.

The stock price will recover. Dead patients won't. And the company won't survive the criminal investigation that follows a cover-up.

This is the only defensible path.