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 INDUSTRY • Basic data SCIENTIFIC LITERATURE • Data UNIVERSITIES Data Consultation NATIONAL RESEARCH COUNCIL OUTSIDE EXPERTS •Special problems Contributions by FDA and Government 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 tolerances 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. SPACE AND FACILITIES 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 26. 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 SALARIES 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. 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 PLANS AND DESIGNS FOR 2 OTHERS 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 SCIENTIFIC AND MEDICAL COMMUNICATIONS cont. • STUDY IN PROGRESS BY OUTSIDE • THE SYSTEM BEING DEVELOPED WILL INCLUDE THE FOLLOWING BASIC FDA WORK PROCESSES • NEW DRUG APPLICATIONS PESTICIDES SAFETY TOLERANCES CHART 30 Several years ago, for example, FDA began to look into the use of automatic data processing systems to assist its programs, particularly the scientific operations. In October 1961, the Data Automation Branch was established and efforts were begun to staff it. Eight months later a relatively small computer was made available to FDA. Since then various computer programs have been developed that are proving to be of considerable value to our scientists and program planning staff. In October 1962, a special group headed by the Assistant Commissioner for Science Resources was designated to (1) develop recommendations to promote and improve the processing and dissemination of scientific information within FDA and with outside organizations; (2) develop a close relationship with other groups working in the information exchange area; and (3) evaluate FDA's adverse drug reactions reporting program. Among the recommendations that this group made was that FDA needed the services of outside experts to 1. Study some of the basic work processes of FDA to determine the feasibility of establishing an agencywide system or systems for the retrieval, utilization, dissemination, and exchange of scientific information and data; 2. Produce recommendations concerning the feasibility of a unified and agencywide system or systems, including suggested methods of approach and specifications to be used by the agency for the subsequent planning, designing, and implementation of such a system or systems; and 3. Produce recommendations for interim changes in data handling techniques where the contractor finds that such changes are necessary and practical. A formal invitation for bids for this study was issued on June 10, 1963, and a final contract was signed on September 9, 1963, with Arthur D. Little, Inc., of Cambridge, Mass., an organization with experience in the design of information handling systems. The study is nearing completion. Realizing that any study will point out the need for developing new techniques of information handling, FDA is taking collateral measures to assure that it will have both the staff and the organization to implement the study's recommendations. The agency is now recruiting for the scarce talents needed in handling mechanized information systems, it is developing special training programs in modern techniques of information handling for some of its present staff. FDA is also working to investigate ways of applying new techniques of information handling to specific programs and problems peculiar to FDA-particularly in the Bureau of Medicine, the Bureau of Scientific Research, and the Bureau of Scientific Standards and Evaluation. Work is also being done to develop new and improved laboratory operations and systems for both headquarters and field laboratories. Another result of the study made by FDA's own group, under the direction of the Assistant Commissioner for Science Resources, was to emphasize the need for improvements in FDA's adverse drug reaction reporting program. By way of background, this program was instituted several years ago as an experiment. Up until that time, no organization had attempted to systematically collect, record, and disseminate information gathered from clinical records concerning |