back to the point of examination, then back to a laboratory, the exchange of information, whether the sample was in violation of the law or not, communication going out to an inspector to seize a product, and so forth. It is a very heavy user of travel and other forms of communication by the very nature of its business. Mr. SHRIVER. As I look this over, it is true in printing and reproduction, other services, the whole realm has increased from three to five times over 1960, and it will continue to increase? Mr. CARDWELL. Yes, sir. The agency grew from 877 employees in 1954 to over 4,000 today. Its programs have grown tremendously. The number of new laws assigned to the Food and Drug Administration in the last 10 years would go up by 10 times perhaps. PUBLIC KNOWLEDGE OF FOOD AND DRUG ADMINISTRATION Mr. FLOOD. How are you accepted by the general public, by the man in the street? Are you respectable? Does he know about you? Are you an organization of integrity? How does the average citizen look upon you? Dr. GODDARD. My knowledge of this tells me that the average citizen looks to us for his protection and if he can purchase a product. then the Food and Drug Administration must have determined it was safe. He places great reliance on the agency and its activities. Mr. FOGARTY. I don't think that is an answer to Mr. Flood's question. I know what the answer is. The average person doesn't know what the Food and Drug Administration does. Mr. FLOOD. That is what I am concerned about. Mr. FOGARTY. They have almost no citizens' committees in the country that inform the people that there is a Food and Drug Administration, such as the American Heart Association, the American Cancer Society, and so forth, in other areas. The consumer groups are not organized, either. Dr. GODDARD. I refer to a more general sense, that people have the feeling that the Government has determined that this product is good, but they don't necessarily know about the Administration. Mr. FOGARTY. If you stop 10 people on the street, 9 would not even know this Administration exists. The main reason is that you do not have citizens groups talking about what you are doing. You cannot do it yourself, unless you get in the headlines because you closed down some pharmaceutical manufacturers, or something like that or the thalidomide incident. Dr. GODDARD. This did a great deal in raising the confidence of the public, which is why I responded as I did, and also the controversy over the birth control pills, and the pesticide problem with foods. I am sure you are right, we can walk across the street, in Providence or my hometown of Atlanta, and find the same problem, people not knowing what the Food and Drug Administration does. Mr. FOGARTY. Any other questions? Thank you very much. Dr. GODDARD. Thank you, sir. Summary of changes 1966 enacted appropriation_ Unobligated balance lapsing Transferred to operating expenses, PBS, GSA, for rent. Total estimated obligations, 1966.. 1967 estimated obligations.. $53, 079, 000 -60, 000 - 140, 000 52, 879, 000 63, 454, 000 Total change.. INCREASES +10, 575, 000 Mandatory: 1. Annualization of 406 new positions authorized in 1966 for 2. Annualization of 269 new positions authorized in 1966 for $1, 130, 200 1 2,006, 400 497, 000 452, 000 Subtotal, mandatory increases... 4, 085, 600 This increase is required to annualize the position plus support items such as informer fees, sample purchases and investigator pay differential which were budgeted for only % of fiscal year 1966, but must be annualized forfall of fiscal year 1967. Decreases: Nonrecurring expenses related to new programs in fiscal year 1966- 1,571, 100 -2 Total net change requested.. 720 10, 575,000 Medical evaluation EXPLANATION OF CHANGES An increase of 42 positions and $597,000 is proposed to enable FDA to process, on a more timely basis, investigational new drug applications and new drug applications in both the human and veterinary areas. This workload also includes supplements and amendments to these applications, as well as the processing of progress reports on such applications. An increase of 31 positions and $312,000 are proposed for medical review including regulatory support, drug surveillance, and evaluation of medical advertising and devices. An increase of four positions and $41,000 are proposed to implement the Drug Abuse Control Amendments of 1965. Fifty-five positions and $1,078,000 are proposed to expand the medical information and communication programs with emphasis on the adverse reaction reporting program, the medical reference service, and implementation of the medical information subsystems which are part of the science information facility. Thirty-one positions and $507,500 are proposed to provide resources for a professional development program, staffing of medical advisory committees, administrative management and supports increased emphasis on review and revision of medical regulations, an expanded program of coordination with the drug industry, and a cooperative research program to support clinical investigations of drugs. Research FDA's scientific research activity, composed of intramural research and cooperative extramural research programs, will be expanded primarily in the food and drug fields. Thirty-one positions and $404,600 would be used for research programs on normal constituent and natural contaminants of foods, research on pesticides and food additives, hazards in foods and for new research programs seeking novel approaches to scientific problems in this area. There will be an expansion of 22 positions and $305,000 for research on drug mechanisms, psychotoxic drugs, exploration of new approaches to drug problems and on drug integrity and misrepresentation. Research on composition and safety of cosmetics will be expanded by eight positions and $160,000. Research sypport activities require an increase of 17 positions and $226,000, including $75,000 for "research breakthrough funds." Scientific evaluation An increase of nine positions and $146,900 is proposed for FDA's programs concerned with the promulgation of food regulations and food investigations. Eleven positions and $225,000 are proposed for the program of pesticide regulation-setting and pesticide investigations for verification of safety or products. An increase of 21 positions and $220,000 is to keep pace with a greater influx of human and veterinary drug submissions from industry and permit the more timely processing of these applications. The resources also permit supporting drug investigations. An increase of two positions and $20,000 will permit expansion of reviews and investigations of hazardous substances. Bureau administrative and statistical support will require an increase of nine positions and $65,000. Education and voluntary compliance Nine positions and $581,900 are proposed to expand the consumer information program. Program emphasis will be placed on greater use of mass media: particularly, television and programs designed for segments of the population with special consumer problems. To expand the voluntary compliance program with regulated industries, including emphasis on industry workshops and training films 15 positions and $184,000 are requested. Five positions and $39,000 are requested to meet industry requests for advisory opinions. In addition, 11 positions and $85,000 are requested for improved and expanded visual and editorial services, program direction and evaluation, and administrative support functions. Regulatory compliance An increase of 170 positions and $1,008,000 is proposed for regulatory compliance activities, relating to drugs. This will permit an increase in the number of inspections and samples analyzed, and will also permit more timely followups and improved surveillance of drug industry control procedures, and increased efforts in education and voluntary compliance by the field. To take advantages of increased productivity in the general foods category, a transfer of 28 positions is proposed from this area to the potentially hazardous foods category. The increase will permit expansion of inspection coverage of the food industry where potentially hazardous problems are present. In the imports area, 30 positions and $173,000 are requested to provide more wharf examinations and in-depth coverage of drug imports. In addition, $384,700 is proposed for such items as telecommunications network, attendance at scientific meetings, increased court costs, equipment, increased training requirements, etc. Drug abuse control An increase of 104 positions and $2,752,200 is needed to annualize the drug abuse control program authorized in fiscal year 1966 and to expand the field investigation program by expanding audit and undercover activities. Executive direction and technical support An increase of 29 positions and $218,000 is proposed for the science information program, which in fiscal year 1967 will be in full-scale development. Six positions and $87,500 is proposed for central laboratory services to meet the anticipated increased workload resulting from increased laboratory capacity at headquarters. Five positions and $219,000 are for the establishment of a new FDA training program. Thirteen positions and $87,200 are requested to provide improved and expanded organization and methods and data processing services. Ten of these positions will be in direct support of the science information program. Twentyeight positions and $249,000 are requested for other administrative areas to expand necessary services such as facilities planning, supply management, records, personnel, and fiscal administration. An increase of seven positions and $243,500 is needed for program planning and evaluation, increased use of outside consultants for committees, improved issuance of regulations and better utilization of scientific resources. With the reorganization of the Bureau of Medicine in January 1965, staff positions were created to assist the Director and to improve Bureau administration. Since that time, the Bureau has moved toward its goals of streamlined processing of drug submissions, more efficient distribution of incoming workloads, improved handling of medical information, an expanded program of professional development and liaison with the medical community, and stronger administrative support within the Bureau. The proposed fiscal year 1967 budget is designed to carry on these improvements and to help accomplish the following broad objectives: (1) eliminate all backlogs of drug submissions; (2) accelerate the decisionmaking process; and (3) fully implement by fiscal year 1968 the Kefauver-Harris drug amendments. 1966 estimate: Positions Amount.. 1967 estimate: Positions Amount. 1967 increase: Positions Amount__ Investigational drug evaluation New drugs 148 $1,918, 000 180 $2,341, 000 32 $423, 000 The Bureau's responsibility in this area is to evaluate manufacturers' applications for permission to use a new drug on a limited basis in clinical trials on humans. These applications are called notices of claimed investigational exemption for a new drug (IND). The major problem in this area has been the large backlog of IND's that accumulated after 1962, when these submissions were first required by law. At that time, more than a thousand applications received in the opening months of the review program created a backlog that has not yet been reduced. There were over 1,450 on hand at the end of fiscal year 1965, and they continue to come in to FDA at a rate of about 70 per month. In addition to these original submissions, FDA receives about 300 amendments and progress reports every 60-627-66-pt. 2——6 |