Introduction
Foreword 2006 Enforcement Story
The year 2006 can be distinguished as a year of transformation, highlighted
with centennial celebrations commemorating FDA’s remarkable history as a world
leader in public health. Protecting and advancing public health is our legacy
and it is our continuing commitment to all Americans in the 21st
century. Being entrusted to enforce our public health laws and regulations is
both a challenge and an honor for the men and women of FDA.
The Office of Regulatory Affairs (ORA) is undertaking our most significant
transformation, an unprecedented effort to revitalize every aspect of our
organization. This transformation is vital, as we honor our proud history and
prepare for the challenges and opportunities that lie ahead. ORA will become a
more dynamic, flexible, and responsive organization, prepared and positioned to
accomplish our mission and realize our vision:
Mission: ORA protects consumers and enhances public health by maximizing
compliance of FDA-regulated products and minimizing risk associated with those
products.
Vision: All food is safe; all medical products are safe and effective; and
the public health is advanced and protected.
The domestic and import enforcement actions in 2006 cover all areas of
product jurisdiction. Many of these actions were taken to protect public health
in one or more of the following areas: preventing noncompliant products from
entering the market, detecting noncompliance, and intercepting noncompliant
products.
As you view the statistics and read the articles, I hope you will share my
pride for all that was accomplished in 2006. Over and above the information
presented herein, FDA’s investigative and compliance staffs, through skill,
communication, persuasion and hard work also protected public health through
less formal compliance approaches, leveraging industry’s cooperation and
objective to comply voluntarily. Overall, our multi-dimensional compliance
efforts have been remarkable and the public health protection and advancements
that have been realized are now a matter of record. We now must look forward
with courage and resolve to conquer tomorrow’s challenges.
It is my pleasure to present The Enforcement Story of 2006.
Respectfully,
David K. Elder
Director, Office of Enforcement |
