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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.

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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:

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1967 estimate:

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1967 increase:

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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

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month, also requiring careful review and anlaysis. The table below relates workload to manpower.

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In fiscal year 1967, FDA proposes to reach a scientific decision on these IND's on an average of 50 days after receipt. Currently it may take anywhere as long as a year to complete some reviews. This shortened period for review will permit FDA in many instances to prevent potentially harmful drugs from being used in clinical tests on humans. Expediting the review process for IND's and eliminating the current backlog will require an increase of 12 positions in fiscal year 1967.

New drug evaluation

Applications for new drugs (NDA's) are reviewed and evaluated to determine whether they establish the safety and efficacy of drugs proposed for interstate shipment and general use. FDA has been advised by spokesmen for the Pharmaceutical Manufacturers' Association that there will be a substantial increase in NDA's during the next few years because the drug industry has adjusted to the requirements of the Kefauver-Harris amendments and will be "pulling a number of drugs off the shelf" for processing by FDA. The table below relates anticipated workload to manpower:

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Additional workload includes amendments to NDA's under review, resubmissions of NDA's, and other correspondence.

The time required to evaluate each of these applications continues to average 180 days, but applications are becoming lengthier and more complex: 10- and 20-volume submissions are commonplace now. With the staff increase authorized for fiscal year 1966, FDA anticipates reducing the time for review from an average of 180 days to 130 days. By fiscal year 1967, FDA's goal is to reach a decision on all of the uncomplicated NDA's within 90 days after receipt, thereby virtually eliminating the backlog of submissions. The accomplishment of these objectives will require an increase of 13 positions in fiscal year 1967.

Antibiotic drugs

Although the primary responsibility of the Bureau in this area is to determine whether scientific evidence establishes the safety and efficacy of antibiotic drugs, the Bureau also must provide medical expertise and support for FDA's antibiotic certification and enforcement programs. Each district office sends in about 25 requests per year for medical advice about antibiotic products; it takes any

where from a day to 45 days to develop a response to these requests. Time must also be devoted to the development of evidence and testimony for court actions. The review workload for antibiotics has tripled in the past year; IND's and supplementary material are now being received at a rate of about 200 per month. In order to keep pace with these submissions in fiscal year 1966, certification personnel must be diverted to regulatory work to support the small staff of four positions. Furthermore, FDA plans to reevaluate in fiscal year 1967 about 150 of the 500 antibiotic preparations marketed between 1938 and 1962 to determine if they are effective as well as safe. In order to meet this workload, an increase of seven positions is proposed.

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This program centers around the Bureau's responsibility to determine whether drugs and devices are adulterated or misbranded. The staff maintains a continuing surveillance of drug labeling and advertising, clinical reports, and adverse reaction reports. It also reviews inspection reports to insure that the manner in which approved new drugs are manufactured, marketed, and distributed adheres to the commitments made by the manufacturers in their NDA's.

Medical regulatory support

The case review staff in the Bureau reviews proposed legal actions involving medical issues and recommends appropriate action on the basis of medical evidence. It also determines the need for field investigations of drug problems, designs clinical investigations, and obtains expert medical witnesses for trials and hearings. The staff in fiscal year 1965 was able to review only about 25 percent of the 200 or more items on hand each week. In fiscal year 1967, this unit must evaluate at least half of the inspection reports from the field and must cope with a larger workload growing out of the agency's responsibility to reevaluate drugs approved between 1938 and 1962, as well as its new program to inspect foreign drug firms exporting drugs that are subject to NDA's in this country. This latter program, which is part of a plan to initiate a food and drug review in 6 foreign countries that are major exporters of potentially hazardous products, will call for 14 additional positions in the regulatory support area to assist in evaluating inspectional findings and to follow up on them whenever necessary. Drug surveillance

Bureau activities in this area involve evaluating the safety and efficacy data and the proposed labeling in NDA supplements. In fiscal year 1965, the Bureau received 1,845 of the sesupplements and processed only 607. Records and reports required for human drugs under the new drug regulations are coming in at a late of 25 a week, in addition to the 4,500 reports received last year under sections of the regulations that require FDA to reevaluate the safety and efficacy of all the drugs that were approved since 1938 on the evidence of safety alone. An increase of 10 positions is proposed in this area for fiscal year 1967. This increase, combined with the full-year efforts of positions authorized during fiscal year 1966, will permit more timely review of these supplements and the elimination of backlogs by fiscal year 1968.

Evaluation of medical advertising

FDA monitors and evaluates medical advertising in professional journals and in promotional labeling, as well as material collected in establishment inspections or submitted in records and reports from industry. Emphasis was placed on this activity in the reorganization of January 1965, with the creation of a specific unit, During fiscal year 1967, FDA proposes to increase its surveillance of prescription drug advertisements by scanning at least 20 percent of them every year, with concentration on those areas where the major advertising problems are occurring, This will require consultation with specialists and extensive review of pertinent medical literature, NDA's, and adverse reaction reports. This staff will also

support FDA plans to initiate an industry information program on the criteria for prescription drug advertisements. To accomplish these objectives, an increase of five positions is requested.

Evaluation of medical devices

During fiscal year 1965, nearly a thousand documents were submitted to the Medical Device Branch for review and evaluation. This was an increase of 36 percent over fiscal year 1964. The staff of this branch developed the medicallegal support for 6 contested device cases and participated in more than 80 seizures. During the same period, considerable staff time was devoted to developing information on methods of therapy for various types of devices. Two additional positions are proposed for fiscal year 1967 to handle a growing workload and to permit the review of classes of devices that would permit FDA action on an industrywide basis.

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To implement the Drug Abuse Control Amendments of 1965, the Bureau will initiate a program of cooperative clinical studies in fiscal year 1966 to determine the effect of psychotoxic drugs on human behavior. This $150,000 program will be continued in fiscal year 1967, with particular emphasis on medical investigation of the causes and circumstances of drug addiction resulting from overuse of certain prescription drugs like amphetamines and barbiturates. Two additional positions are requested for this program.

In fiscal year 1966, a medical advisory committee was established to provide FDA with information about drugs having depressant and stimulant effects, in order that they can be added to the list of those regulated by FDA. One position is needed in fiscal year 1967 to support and help implement committee recommendations. In addition, one position is proposed to maintain liaison with groups involved in studies of the legal, sociological, and psychological aspects of drug abuse and addiction. Through this contact, FDA can improve its medical educational programs for both industry and the general public.

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The unit responsible for this program makes a preliminary review and analysis of all adverse drug reaction reports coming into the Bureau. Hospitals are among the best sources for reports of this kind, and in fiscal year 1965, the agency increased the number of hospitals reporting under contract from 79 to 120. During fiscal year 1966 this number will increase to 300, and the number of Government institutions reporting at no cost to FDA should also increase. About 6,000 reports, involving 2,000 drugs, were received in fiscal year 1965. FDA will budget $382,000 in fiscal year 1966 to cover the costs of this program, plus $50,000 for data on the University of Pittsburgh's model prescription recording system, and $15,000 for extensive drug and device data from the National Center for Health Statistics. An increase of $155,000 is proposed for fiscal year 1967 to cover the cost of adding 100 hospitals to the adverse reaction reporting program. Another increase of $400,000 is needed to initiate a cooperative study with a major medical foundation, which consists of 300,000 individuals who belong to a

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