and the number of petitions that are filed in that area. A food additive petition, in many respects, has problems that are quite comparable to the problems that you and your staff have been studying on new drugs. Chart No. 20 deals with another problem which has been very much in the public eye and that is the use of pesticides in the growing of agricultural commodities in this country. It is impossible to produce the variety and the quality of foods and agricultural products that we need to feed our people without the use of these pesticides, but there are grave problems in their use. It shows here that we have sampled and analyzed some 25,000 samples of fruits and vegetables as they moved to the market during the past year to attempt to discharge our responsibilities in this area. Finally in this chart No. 23 it shows there are some 360,000 shipments of foods, drugs, and cosmetics which entered through the ports of this country last year, and that the value in dollars was some $6 billion. We sampled 4 percent of them, because that was all we could afford to sample, but of those sampled, one-third were in violation of the law. However that does not mean that one-third of the products imported are in violation of the law. The experience and the knowledge that our people have of where the trouble spots are apt to be results, hopefully, in our being able to choose our samples where they will do the most good. Mr. FOUNTAIN. After the subcommittee has had an opportunity to examine your statement and inserts carefully, we will endeavor to include them in the record at what we believe to be the most appropriate place. We want to be sure the full intent and purpose of your statement today is understood clearly and for that reason, it is possible we may decide to put this at some other point in the record. Mr. LARRICK. I will be quite happy to be guided by the judgment of you and your staff. (The background statement and charts follow :) STATEMENT OF GEORGE P. LARRICK, COMMISSIONER OF FOOD AND DRUGS, U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE BACKGROUND OF THE FOOD AND DRUG ADMINISTRATION INTRODUCTION As an aid to the committee in considering the Food and Drug Administration's policies and programs for the regulation of new drugs, the following background information is provided. It attempts to summarize the more significant circumstances that have affected FDA through the course of its history, with particular emphasis on the many changes that have taken place in the Nation's population, economy, technology, and food and drug statutes during a time when FDA was struggling for adequate resources to meet these changes. The laws THE PAST The Food and Drug Administration was born 58 years ago out of a national sense of urgency that certain glaring wrongs should be corrected. A series of dramatic disclosures over a period of years, essentially involving harmful food adulterants and fake medical preparations, led to the enactment in 1906 of the Federal Food and Drug Act. For 25 years before 1906, attempts by Dr. Harvey W. Wiley and his associates to pass similar legislation had failed. It is unfortunate, yet true, that most of the major changes and improvements in the Nation's food and drug laws have been made following dramatic, and often tragic, circumstances. For example, it took over 30 years to get a much-needed major overhaul of the 1906 statute. The spark in this case was the so-called Elixir of Sulfanilamide tragedy in 1937. Over 100 Americans, many of them children, died because a sulfanilamide new drug preparation contained diethylene glycol, a highly toxic solvent. This episode was promptly followed by enactment of the Federal Food, Drug, and Cosmetic Act of 1938-the law which to this day remains the foundation stone of American consumer protection. Charts 1 and 2 show the major changes that have been made in the statute since that time. Several of the amendments noted in charts 1 and 2 represent significant advances in food and drug law. However, most of them came after serious defects in the 1938 law had been revealed by FDA inability to cope with existing problems under existing law. The most recent statutory improvement was enactment of the Kefauver-Harris Drug Amendments of 1962. These resulted largely from the unforgettable Thalidomide tragedy where thousands of European babies were born with serious deformities. The agency The laws on which FDA's authority rests are primarily regulatory in nature and by their very essence make FDA a law enforcement agency. However, because the areas of human activity that FDA regulates are characterized by a high level of scientific and technological development, the agency has always relied heavily on the scientific disciplines in administering the law. The role of science in FDA goes back to the very beginning when implementation of the 1906 act was placed in the hands of the Bureau of Chemistry of the Department of Agriculture. Since then, the physical and medical sciences have 1960 Federal Hazardous Substances | 250,000 Household products are subject Labeling Act 1960 Color Additive Amendments 1962 Kefauver-Harris Drug Amendments 1962 Investigational Drug Regulations to safety labeling requirements 450 Manufacturers and packers of colors CHART 1 14,000 Drug Establishments must be inspected every two years: 10,000 adverse reaction reports must be evaluated 2.000-New drugs are clinically tested by CHART 2 played a vital role in FDA's programs. Not only FDA laboratory scientists but also its inspectors are required to have college science backgrounds. The laws that FDA enforces also have the potential of profoundly affecting the rate of progress this Nation can make in food, drug, and cosmetic science and technology. They are laws which have fundamental impact on the industry and commerce of our Nation. This is true not only in the case of new drugs, but it also applies to the development and use of new food additives, color additives, agricultural chemicals, and therapeutic devices. These laws affect manufacturing, processing, and distribution techniques. They apply to research and testing procedures and to a host of other factors profoundly related to the progress this Nation can make to provide us all with better health and improved standards of living. Enforcing such laws not only calls for the most qualified resources of the scientific and medical disciplines, but it also requires administrative judgments of the highest order. Both are necessary to provide maximum protection not only to the legitimate interests of consumers, but also to the Nation's basic interests in scientific and technological progress. If such is the case, it seems that it is vital to implement laws, especially those with the far-reaching effects that U.S. food and drug laws have at all levels, with people who have the capacity to grasp and understand as fully as possible all the implications of a given statute; men who are administrators in the broadest sense, who have a keen insight into the balance that is necessary between the public that is served by the law and the interests that are regulated by the law. Since its origin, FDA has tried to find such individuals to administer its programs. Although they represent an extremely scarce category of talent, the agency has, nonetheless, met with significant success, and it is fair to say that few regulatory agencies of the Federal Government can boast of having over a half century's record of more vigorous, effective, and fair enforcement of the law. Resources The Food and Drug Administration has long suffered from a serious lack of resources to do its job. But the chronic degree to which this has been the case deserves some amplification if a thorough understanding of FDA is to be had. During the first half of this century, when the food, drug, and cosmetic industries were in the midst of a technological revolution, FDA grew at a snail's pace, and even remained static for long periods. In 1957—a half century after enactment of the original law-FDA began to move forward and resources essential for the agency to do its job began to be provided in more adequate fashion. This change was largely the result of a study made by a Citizens Advisory Committee in 1955, a study that highlighted the serious condition FDA was in and kindled a new awareness of the agency's needs. As chart 3 shows, from 1938 through 1957 the agency's staff hardly increased at all. As a matter of fact, by 1955 the total staff numbered 829 as compared to 823 10 years before in 1945. Chart 4 gives the same picture in terms of appropriations for this period. Here again, between 1938 and 1957 FDA's budget hardly moved forward at all, despite increasing costs for personnel, equipment, and facilities. There were 2 years in the early 1950's when the agency suffered reductions in staff because of inadequate financial resources. By 1955, FDA had a budget of $5.5 million. The significance of this static period can best be evaluated by looking at the other developments going on in the Nation during the same time; developments such as population growth, economic expansion, and changes and advancements in technology. The total U.S. population grew by 31 million between 1938 and 1955. It is expected to number 194 million in 1964, and the Bureau of the Census predicts between 216 and 244 million by 1975. In addition to the effect that sheer numbers of consumers have on FDA operations and programs, the agency is also affected by the way the population is distributed. In this connection it is well to note two important trends that have accompanied U.S. population growth over the past several decades. One of these has been the phenomenal shift from farms to cities. This has had a direct effect on FDA's job, because city dwellers are far more dependent on mass-produced foods than are citizens who live on farms. Most of the technological developments for the preservation, packing, and distribution of foods, for example, have been stimulated by the industry's need to provide for a fast-growing U.S. urban population. Whereas U.S. farm population was 31 million in 1938, it is less than half of that number today; and whereas the urban population was 99 million in 1938, it is nearly double that number today. The other trend that has characterized the population explosion has been the growing segment made up of citizens 65 years and older. A dramatic shift has been taking place since 1938 as chart 5 indicates, where citizens 65 and older have increased from 8.4 million in 1938 to more than double that figure today. The problems of these older consumers are considerably different from those of other groups in the population. They depend a great deal more on drugs, special dietary preparations, and nutritional products. Since they are prone to various degenerative diseases, cures for many of which have not yet been found by medical science, they are often the victims of charlatans and quacks who take advantage of the condition to sell them fake and often highly dangerous— products. As chart 6 shows, while the population was growing in a straight line, FDA was struggling to maintain what small staff it had at the end of World War II. This situation continued until relatively recent years. RATE OF U.S.A. POPULATION GROWTH MILLIONS OF PEOPLE 170 " THOUSANDS OF PEOPLE 3 In addition to population, however, it is also important to note what was hap pening to the economy during those same years. Here again, FDA and its programs are directly affected, because as the American standard of living increases, the consumption of products falling under FDA jurisdiction also increases, industries expand, distribution outlets increase, retail outlets and sales go up. The expansion of the economy is demonstrated by the growth in the gross national product from $90 billion in 1938 to $360 billion in 1955. The 1964 estimate is for a GNP of about $625 billion and the Committee on Economic Development has projected a $725 billion GNP by 1975. At the same time that the GNP has been growing so has the personal consumption expenditures for foods, drugs, and cosmetics. This growing economy and this more affluent population have |