As chart 23 shows, this year approximately 360,000 shipments of foods, drugs, and cosmetics worth $6 billion will reach U.S. ports. FDA has the manpower to sample approximately 4 percent of these shipments. Yet, based on the experience of prior years, it is expected that approximately one-third of all the shipments checked will show violations under the Federal Drug and Cosmetic IMPORTS 360,000 SHIPMENTS FDA SAMPLES 4% % OF PRODUCTS CHECKED ARE CHART 23 Act and have to be detained. This does not mean that one-third of all shipments show serious violations, because FDA inspectors are quite selective in their operations. However, if American consumers are to be adequately protected against harmful imports, and if the American industry is to be protected against unfair foreign competition, much more work is necessary in this important area. COMPLEX OPERATIONS In addition to the consumer problems briefly touched upon above, FDA also is challenged by administrative and management questions that must be resolved in the interest of effective and efficient operation. These are largely of three types: (1) Those resulting from complex work processes; (2) those caused by inadequate space and facilities; and (3) those related to inadequate salaries. FDA has a tremendously complex operation for two basic reasons: First, because the laws FDA administers require demanding procedures, such as the processing of petitions, review of plans for clinical testing of new drugs, the approval of new drugs, the establishment of tolerances, the issuance of regulations, and the conduct of hearings; second, because the nature of FDA's work demands high knowledge of and dependence upon scientific technology, medicine, law, and other complex disciplines. In addition, FDA recognizes the need to regulate industry fairly and in a manner permitting the maximum amount of technical and economic progress consistent with the public well-being. Chart 24 illustrates the interrelationships between the scientific community, Government, and industry in any decision which FDA makes to approve pesticide, food additive, or color additive petition, a new drug application, or a proposal for an investigational drug. As can be seen, practically all of FDA's major organizational units participate in such activities. For example, the Bureau of Scientific Research and the Bureau of Scientific Standards and Evaluation bring their scientific skills to bear in the evaluation of all of these proposals. In the case of a new drug application, for example, the Bureaus evaluate the pharmacology of the drug. The field inspectors and laboratories verify the information submitted by industry through Inspections, sample collections, and laboratory analyses. FDA medical officers and other scientists in the Bureau of Medicine are called upon not only to review the manufacturing, laboratory, and control procedures used by the manufacturer and the evidence of safety and effectiveness of the product for its intended use but also the truthfulness of the proposed labeling. In addition to the work the Bureau of Medicine does with respect to new drug applications, it also reviews the medical aspects of pesticide, food additive, and color additive proposals. DATA FOR DECISIONS Contributions by Scientific SCIENTIFIC LITERATURE •Special problems NATIONAL SCIENCE FOUNDATION CHART 24 In deciding whether to approve or disapprove a given proposal, FDA reaches beyond its own staff to obtain data and advice. Industry itself provides much of the basic information that supports a proposal. FDA also depends heavily upon other units of Government, such as the Public Health Service, the Department of Agriculture, the National Science Foundation, and others. In addition, universities, hospitals, clinics, and non-Government experts play a part in such decisions, not to mention the contributions made by literature emanating from the scientific community in general. The preceding discussion of FDA's review of industry proposals illustrates a significant trend of the past 30 years in the administration of the national pure food and drug laws; that is, the trend toward fuller utilization of preventive measures. The 1906 law was punitive in the main and accomplished its purpose by punishing misdeeds after they occurred. The 1938 law adopted in its provisions the concept of preventive enforcement for which administrators of the old act had been striving. It placed legal sanction behind the advisory color standards. It authorized the establishment of standards of identity and quality for food thus recognizing the value of the earlier advisory standards. It authorized (in a way that had to be improved later, it is true) the establishment of toler ances for toxic materials required in production of food. And particularly, it required premarketing clearance of new drugs for safety. This basic philosophy has been reflected in amendments to the 1938 law. FDA's entire rulemaking process, which today is very extensive, is designed to acquaint the manufacturer with the steps he can follow to comply with the law. With this evolution of law has come an evolution of administration. FDA seeks increasingly the assistance of the scientific community in resolving questions presented by new science and technology. In addition to the complexity of FDA basic operations, many business management decisions prove to be equally critical to our successful operation. One of these involves the agency's space needs, as explained in chart 25. FDA's headquarters operations have been scattered in numerous locations for years, resulting in a serious drag on efficiency. The agency has been suffering from acute space shortages, and its facilities have been substandard. Quarters are old and were constructed for purposes other than the specialized needs of the agency. Many laboratories, for example, are in the South Agriculture Building constructed nearly 30 years ago. Much of FDA's staff is housed in World War I and II tempos, and even in a former nurses' home. All this has seriously handicapped not only operations but also the ability to attract and retain skilled personnel, such as medical officers and scientists. FDA is also faced with similar problems in the field, as shown in chart 28. Until 1958 all field laboratories were located in facilities that had been designed for other purposes, including post offices and customhouses. As of today, 7 of the agency's 18 districts are still housed in such facilities and are awaiting modernization, although the 1964 budget contains funds for 2 of these. SPACE AND FACILITIES UNTIL 195S FDA FIELD LASS WERE HOUSED IN OLD AND OODED FACILITIES... MANY WERE HOUSED IN BUILDINGS COCTED BEFORE THE TURN OF THE CENTURY. COUCTION FUNDS HAVE BEEN MADE AVAILABLE TO ERNIZE OUT OF 1 FDA DISTRICTS. As can be seen by chart 27, despite recent Government-wide legislation designed to raise Federal salaries, FDA, along with other agencies in need of highly specialized skills, is still lagging behind universities and industry. This is particularly true with respect to medical officers where FDA can pay anywhere from a quarter to a third less than what M.D.'s can earn in our medical schools or in private practice. The salary rates that FDA can pay for pharmacologists, chemists, and other scientists are likewise inferior to those private industry and universities can provide. WHAT IS BEING DONE TO SOLVE THESE PROBLEMS All of the proceeding discussion leads to a description of what FDA needs to do to meet the problems it faces so as to assure the Nation's consumers of adequate protection now and in the future. FDA efforts to prepare for the future are directed essentially to four areas. These are (1) continuing the struggle for appropriations and staff to strengthen FDA's consumer programs; (2) taking concrete steps to try to improve FDA's salary scale in order to be able to attract and hold on to needed, scarce skills, such as doctors and scientists; (3) taking positive measures to improve the organization and internal operating procedures; and (4) developing and supporting proposals for new laws to improve FDA's ability to protect consumers. Additional resources While there is a pressing need for additional resources the budgets must reflect the rate at which FDA can assimilate the increases. The fiscal year 1965 budget, pending before the Congress, would continue the progress that has been made since fiscal year 1957 as shown in chart 28. It would add 215 people to the staff, bringing the total to 4,039, and it would increase appropriations from $35,805,000 to $39,500,000. In addition, it would permit FDA to make substantial strides in solving space and facilities problems by authorizing the construction of an additional laboratory building at headquarters and the modernization of three of the five district office-laboratory buildings yet remaining to be modernized under a program begun in 1958. Salaries As already mentioned, the salary scale which is authorized for FDA has represented a considerable stumbling block to the agency's ability to recruit and to keep hard-to-find personnel. Since a large portion of the staff is made up of doctors, veterinarians, pharmacologists, chemists, etc., this handicap represents a problem of serious dimensions. Until recently, for example, FDA was authorized only 20 special salary rate positions, that is, positions that are paid from CONSTRUCTION OF NEW HQS. LABORATORY BUILDING CHART 28 $16,000 to $20,000 per year. Some months ago FDA sent through Secretary Celebrezze to the Civil Service Commission a request for 45 additional supergrades with salaries ranging from $16,000 to $18,000 annually. All of these were for medical officers and scientists. Some time ago, the Civil Service Commission approved 29 of these. The agency is planning to request additional medical and scientific supergrade positions made necessary by the recent reorganization. Thus, some headway is being made to try to solve this problem. In addition, FDA intends to continue to take advantage of every opportunity available under the law to obtain a better pay scale for its professionals, a scale which hopefully will some day be more compatible with industry and private institutions. Improvements in data processing and scientific communications FDA has taken a number of concrete steps to improve certain operating procedures, steps motivated both by its own recognition of the need for improvements as well as by observations of outside groups. As charts 29 and 30 show, many of these steps have been directly related to science communications and data processing problems. SCIENTIFIC AND MEDICAL COMMUNICATIONS |