Understanding the Essential Regulatory Public Policy and Ethical Considerations for Product Recalls

As companies respond to the heightened attention being paid by the FDA, Congress and the media to recent product recalls, it has become vital for industry professionals to increase their preparedness and be ready to develop tactical plans of action for risk assessment and management when future situations arise. We are now in a new, more litigious environment, with plaintiff attorneys mining recall statements for potential liability theories, and the government threatening to employ rarely used doctrines of corporate officer liability to go after individual life sciences executives. In response, industry counsel must learn how to work more in tandem with regulators, ensure that agency personnel are in receipt of appropriate information, and that they have the opportunity to provide the company with input. It is also now essential that companies know how to keep from opening the door to additional legal actions when they are drafting recall communications and other critical documents.

With every recall presenting unique challenges, American Conference Institute’s Summit on Drug and Device Product Recalls will bring together industry leaders who will share with you their proven strategies for determining when and how to execute one under complex and divergent sets of circumstances.