Mr. LARRICK. As I have said, we are glad to appear before your committee to discuss the handling of new drugs by the Food and Drug Administration. In order that this one activity of the FDA may be viewed in some perspective, we have prepared a discussion of our overall responsibilities and facilities for discharging them. Briefly, the Food and Drug Administration is responsible for some $125 billion worth of commerce in foods, drugs, and cosmetics, in interstate and foreign commerce. The organization operates 18 field district laboratories scat tered from Boston to Los Angeles where the bulk of our analytical and inspectional work is done. Our total staff of around 4,000 is divided about 57 percent in the field and 43 percent in Washington. I would estimate that we spend on drugs as a whole some 30 percent of our total manpower and facilities. If I may, I would like to submit for insertion in the record at this point a more detailed statement which does attempt to deal with the total responsibilities of FDA, so that if you wish, you may look at the drug activities in which you are particularly interested, with a reference to the whole. Mr. FOUNTAIN. If there is no objection, it will be done. I would like to ask you if you feel the material you are inserting from the standpoint of the readability of the record should come at this particular point. Mr. LARRICK. I would leave that to you and the staff, sir. But in my own view, to look at the problem, we should first look at the whole work of the FDA and then go on from there. To simplify it, for some of you who won't have time to read all of the material, we have prepared a few charts which show for example the increase in our appropriations from around $5 million in 1955 to some $39 million this year. That is chart No. 4. We have broken down our appropriations on a chart No. 7 to show the per capita expenditure for the consumer protective operations in which the FDA engages in the field of foods and drugs and cosmetics. This shows for example the total cost to the American public for whatever protection we provide was 2 cents per person in 1938, and has risen to about 15 cents per person in 1963. Mr. FOUNTAIN. May I interrupt you? I was interested in noting that in 1955 the per capita cost had risen to just 3 cents. Mr. LARRICK. That is correct, sir. It was 3 cents in 1955. Mr. FOUNTAIN. So you have a period of about 17 years there when the increase per capita was only about 1 cent! Mr. LARRICK. Yes, sir. We fell far behind in assets to deal with our responsibilities. Mr. FOUNTAIN. Go right ahead. Mr. LARRICK. I have also a chart No. 9 which very succinctly shows the basic organization of the FDA as reorganized in 1963 in an attempt to deal more adequately with the increased responsibilities which the Congress has seen fit to give us. Chart No. 18 shows that in 1963 we inspected some 20,000 of the 88,500 food establishments subject to FDA jurisdiction and shows that our facilities are such that we can inspect these firms on an average of once every 4 years. Another chart, No. 19, deals with the gigantic problem which arises because of the enactment of legislation dealing with additives to foods, 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 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 MORE LAWS TO ENFORCE 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 CHARTS 450 Manufacturers and packers of colors 14,000 Drug Establishments must be inspected CHART & 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 mannfacturing, 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 cronic 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 1988 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. DRUG SAFETY 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 |