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CRISIS MANAGEMENT
- ♦ Class I recalls (those involving death or serious adverse health
consequences)
- • Publicity coordination
FDA
Media
• Logistics
Depth of recalls
Ensuring the word gets out
• Products Liability considerations
- ♦ Permanently withdrawing products from sale for safety or
effectiveness reasons
- ♦ Internal Investigations
- • Conducting
• Documenting
• Liaison with FDA and other governmental agencies
- ♦ Corrective Action Programs
- • meeting FDA requirements
• relationship to sentencing guidelines
• Corporate Codes of Conduct -- developing and implementation
- ♦ Criminal prosecutions
- • coordinating with key outside parties
• maximizing corporate protections
- ♦ SEC disclosure requirements and the investment community
♦ Impact on pending FDA approvals
♦ Shareholder concerns
- • Securities litigations
• Derivative actions
- ♦ Qui Tam litigation
♦ Competitor civil suits (e.g., under RICO, Lanham Act)
♦ Management disruption
♦ Government contracting eligibility -- suspension or debarment
♦ Addressing possible voidable contracts (e.g., bank loans; mortgages)
♦ State licensing proceedings
- •manufacturing
•formularies
- ♦ Contract Breach Lawsuits
- • Key customers
• Major suppliers
To see presentations and articles on Crisis Management in the FDA
arena, just click here ...
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