Inspections, Compliance, Enforcement, and Criminal Investigations
Foreword 2007 Enforcement Story
Glancing at 2007 in the rear view mirror - images of significant recalls, an expanding global economy, an unprecedented volume of imported products, and the challenge of coping with increasingly complex products and manufacturing processes - all remain closer than they appear. Each of these phenomena presented unique opportunities for leveraging, education and outreach activities, risk-based inspection and enforcement initiatives, and creative approaches to achieve compliance and protect public health.
Noteworthy and largely unparalleled in their scope and public health impact, recalls required a significant investment of Agency investigative, compliance, communication, and scientific resources. In all cases, we had three priorities: investigate the situation to determine the root cause of the problem and to assure that timely corrective and preventative action was taken; communicate with the public, our domestic and foreign regulatory partners, and other stakeholders; and closely monitor the efforts of the recalling firm to ensure the effectiveness of the recall.
In terms of their volume, wide-spread distribution, and severity of the hazards they posed, two of the most significant recalls in FDA history occurred in 2007: pet food contaminated with melamine and its analogs and canned chili sauce contaminated with C. botulinum. FDA's swift and aggressive efforts to contain these events, in collaboration with our domestic and foreign regulatory partners to assure that these recalls were properly executed, saved both human and animal lives by reducing exposure to unsafe products.
FDA's steadfast efforts to protect the public health are also advanced through outreach and leveraging activities. In this year's Enforcement Story, we are proud to highlight our proactive accomplishments in this important area.
The enforcement and advisory actions included in the 2007 Enforcement Story cover all product areas over which FDA has jurisdiction. All of these actions resulted in protecting the public health by one or more of the following ways: preventing noncompliant products from entering the marketplace, detecting noncompliance, and intercepting noncompliant products. FDA remains committed to take any risk-based enforcement actions that are necessary to safeguard the health of American consumers and expects strong corporate responsibility in our regulated industries to prevent and correct violations. FDA has and will continue to dedicate resources to areas of greatest risk and public health significance - for example, an extensive seizure of heart valves where sterility could not be assured and an injunction against a manufacturer of more than 100 drug products, some of which were unapproved, that were not manufactured under good manufacturing practices. FDA has also taken, and will continue to take, actions in areas that require intervention to address violations of the law - for example, a seizure of misbranded olive oil and a mass seizure of food and drug products produced and stored under insanitary conditions.
In 2007 alone, FDA import operations processed approximately 16 million lines of products contained in import entries and encountered previously unmatched health hazards resulting from imported products. These included melamine and melamine analogs in imported vegetable protein products used in pet foods; a toxic chemical, diethlyene glycol, in toothpaste imported from China; and the presence of unapproved drug residues and chemicals in five (5) types of aquacultured seafood products from China. Each of these events resulted in the prompt issuance of Import Alerts, thereby preventing these potentially violative products from reaching consumers in the United States unless proven safe, and unless appropriate evidence demonstrated that they had been manufactured with proper controls in place. Day in and day out, the remarkable efforts of FDA staff who work in the area of Import Compliance prevent adulterated or misbranded products from entering U.S. commerce.
FDA's Office of Criminal Investigations (OCI) marks its 15th year in operation and continues to complement FDA's civil enforcement actions with its numerous and significant criminal cases. In 2007, OCI investigations resulted in 496 arrests, 344 convictions, and $1.92 billion in fines and restitution. An OCI investigation of the maker of OxyContin resulted in a plea of guilty by the company to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, the company agreed to pay a $600 million settlement which included a criminal fine, restitution to government agencies, over $276 million in forfeiture, and a related civil settlement in which the company agreed to pay $100.6 million to the United States. In addition, three of the company's executives pled guilty to a misdemeanor violation of misbranding OxyContin.
The future will continue to present changes, challenges, and opportunities. There exist no higher standards or expectations for FDA than those to which we hold ourselves accountable. The men and women of FDA are proud and honored to be entrusted with fulfilling the noble mission of our Agency to advance and protect public health.
I am dedicating this year's Enforcement Story to Ms. Eileen Rhoads, the principal author of the Enforcement Story since its inception. Ms. Rhoads retired in February after a distinguished career with FDA. She served with enthusiasm, dedication, excellence, class and an unfaltering belief in all that we do.
It is my pleasure to present The Enforcement Story of 2007 and to dedicate it to
Ms. Eileen Rhoads.
David K. Elder
Director, Office of Enforcement
Office of Regulatory Affairs