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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Introduction


Introduction

 

Foreword

 

As we celebrate our centennial, I look back to our beginnings with amazement and with pride at the similarity of our operations, our concerns, our challenges, our successes, and the quality of our people. In 1956, during our 50th anniversary, a book of articles, prepared by members of the Food and Drug Administration and a few close observers, was published. This book, entitled The Impact of the Food and Drug Administration on Our Society1, served as the inspiration for this foreword.

Our Commissioner in 1956, George P. Larrick, wrote: “The most important task of this government bureau is to protect consumers against harmful, insanitary, and falsely labeled foods, drugs, cosmetics, therapeutic devices, and the like.” Charles Wesley Dunn, President of The Food Law Institute put it this way: “The FDA has a tremendous responsibility of protecting every man, woman and child in this country from death or injury by the adulteration or misbranding of food and drugs, and it has successfully met this responsibility, notwithstanding the handicap of inadequate appropriations.”

Today, we continue to protect and advance public health through assuring compliance with FDA laws and regulations. Mr. Dunn described our law as “a great public law of profound social and economic importance to our country.” Associate Commissioner for Laboratories, Robert Roe, predicted that the laws of 1956 would be inadequate for the future as “The future problems of the atomic age will require that the legislation keep pace as far as possible with scientific advances and, particularly, that the enforcing agency be provided with facilities, including trained manpower, to administer effectively such legislation in the protection of consumers.” Our laws have indeed evolved in our second fifty years and must continue to evolve to fully support our noble mission.

To ensure the safety and integrity of the products we regulate, FDA conducts inspections and surveillance of establishments throughout the nation, at ports of entry, and in foreign countries. We collect and analyze samples to determine their safety, effectiveness, quality, purity, and truthfulness of labeling.

Fifty years ago, the Agency carried out its work with 1033 people, 571 of whom were assigned to field laboratories and inspection offices. Today, our Agency has grown tenfold and our field force has grown more than fourfold yet the observation of Chief Inspector Franklin Clark in 1956 remains a current reality. He described the inspectors and chemists as public servants of the highest order and “without their unflagging interest, ingenuity, and accuracy, the American consumer would soon become the victim of caveat emptor.” To accomplish the mission, the inspectors and chemists, through research, study, and resourcefulness were able to meet the challenge of swift technologic advancements in products and manufacturing technology. Mr. Clark concluded, “These public servants are fully aware of their tremendous responsibility. Their pride and satisfaction in the essential job they are doing together is great. The security of the contents of our medicine chests, our refrigerators, and our pantries is in good hands.” Joseph Maguire, Assistant Chief Counsel appreciated how court contests begin with the work of our educated and highly qualified inspectors. “Their training and instructions,” he reported “are directed to the execution of the minutiae of each assignment with such a degree of attention to detail that the work product, if subjected to judicial scrutiny, would not be found wanting.” The sample he described as “meticulously documented, identified, and sealed.”

Commissioner Larrick described the field staff as the eye and ears of the Agency and the factory inspection as “the keystone of FDA enforcement.” He notes that in most instances, our inspections find the facility inspected to be beyond reproach but on the occasions where the firm’s output is suspect, shipments are traced, samples are analyzed, and corrective action ensues. “The basic philosophy of the Food and Drug Administration is to use every proper procedure to try to prevent violations of the law.” Commissioner Larrick recognized the importance of educating firms to provide knowledge of what the law requires and also that our industry had a keen sense of their responsibility. Our resources, therefore, could be focused on fringe groups that are either careless or culpable. “When significant and substantial violations of the law are uncovered, it is the policy of the Food and Drug Administration to pursue their prosecution with vigor.”

In a letter to a physician in his hometown, the head of our San Francisco district wrote, “It is fortunate indeed that in the 50 years since the Wiley law went into effect, the vast majority of those who produce foods, drugs, devices, and cosmetics have accepted fully their responsibility to the American consumer, thus permitting our little group to concentrate on the heedless, the careless, and the greedy.”

Henry Lepper, an attorney with the Department of Health, Education and Welfare, succinctly described the role of enforcement: “The public largely assumes that everything it buys is safe, clean and truthfully and informatively labeled. It is the enforcement official’s responsibility to make and keep it so.”

A strong, effective, and efficient enforcement of FDA laws and regulations is essential to our mission of protecting and promoting public health. Enforcement actions also play an important part in ensuring that the American people can have confidence in the safety, quality and integrity of the U.S. food and medical supplies.

Effective enforcement sends an important message to industry that there is a price to pay for violating FDA laws and regulations by offering unsafe or ineffective products to the consumer. Whenever the Agency learns of unsafe or illegal products, it moves swiftly to take whatever appropriate actions are needed to protect the public and assure full compliance with the law.

The Agency has a range of actions it can take in these instances yet the basic tools of 1956 remain in place: seizure, injunction, and prosecution. For less serious, less threatening breaches, we seek informal means to achieve compliance. More formal written warnings are issued in other situations whereby we expect prompt corrections to achieve full compliance with the law. Violators who do not heed these warnings, however, or whose actions pose a more serious public health risk may be subject to more formal and severe measures. The Enforcement Story outlines the Agency's significant enforcement accomplishments over the past year -- including seizures, injunctions, prosecutions, disqualification of clinical investigators, civil money penalty cases, examples of the types of Warning Letters issued, and recalls. Through case studies and statistics, The Enforcement Story highlights the crucial work performed by our FDA inspectors, investigators, criminal investigators, analysts, compliance officers, and others in the field and in our Centers who work to ensure that products used by consumers are both safe and effective.

When looking to the future, Commissioner Larrick’s words from 1956 ring true today. He described the Agency as being at a crossroads, faced with significant technologic developments, population growth, increased volume of products, discovery of new drug products, and repeated amendments to the law. With his finger on the pulse of the country, he noted “There appears to be a growing realization on the part of the consuming public, and particularly in the affected industries, that a strengthened FDA is desirable not only from the standpoint of the American public but from the standpoint of the industries as well.”

As FDA moves into our next 100 years, I pray that we are able to honor the generations before us by continuing on their path, learning, and teaching the generation that follows. “If we can see farther than our ancestors, it is because we are standing on their shoulders.”

It is my pleasure to present The Enforcement Story of 2005.

Respectfully,

David K. Elder
Director, Office of Enforcement
Office of Regulatory Affairs

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1). The Impact of the Food and Drug Administration on Our Society, Edited by Henry Welch, Ph.D. and Felix Marti-Ibanez, MD. Published by MD Publications, New York, New York, 1956.