FDA's Crisis Management Plan

The U.S. Food and Drug Administration’s (FDA) Crisis Management Plan is currently under review.  An updated version will be available during the second half of 2009.  This review is being conducted in tandem with the work of the FDA Crisis Response Working Group.  Below is a brief explanation of the purpose and goals of the Crisis Management Plan.

The U.S. Food and Drug Administration (FDA) has a complex and critical purpose.  The FDA must protect all Americans from public health hazards ranging from debilitating to deadly.  It does this by ensuring the safety, quality, and effectiveness of a trillion dollars' worth of products that constitute nearly one-fourth of the total consumer expenditures of U.S. citizens.

In today’s global economy and complex geo-political environment, there is an ever-increasing possibility that crisis situations relating directly to FDA-regulated products will occur with increasing frequency.  The FDA recognized the need to adapt to these new challenges and established the Office of Crisis Management (OCM).  OCM serves as the Agency’s first response organization in emergency and crisis situations involving FDA-regulated products.  OCM coordinates intra-agency and inter-agency activities related to crisis management, emergency preparedness and response, and security operations, including implementation of the Agency’s Strategic Action Plan.

In accordance with the FDA’s Strategic Action Plan, OCM developed a crisis management plan to provide the FDA with a structured methodology that enables the Agency to respond to crisis situations that are beyond the capabilities of existing FDA emergency response resources.  While the FDA has always effectively managed crises, the development of a formal plan serves to increase the collective preparedness of the Agency. 

The purpose of the FDA Crisis Management Plan is to provide information about managing a coordinated response to crisis situations that could disrupt the performance of the FDA mission.  To accomplish this, the plan:

• Describes the process by which the FDA identifies a crisis.
• Describes the role of crisis communication in response to any identified Agency crisis.