month, also requiring careful review and anlaysis. The table below relates workload to manpower. 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: 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. 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 rate 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. 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. 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 prepaid medical plan. Through coded diagnostic and drug utilization information on these patients, FDA will be able to make determinations and projections of the incidence of reaction and of disease in a given population, and determine the relative safety and, in some cases, the efficacy of two or more drugs marketed for the same purpose. The cost of this contract is based on an estimated receipt of 270,000 reports each year, at a cost of $1.50 per report, cataloging drug data for a million and a half outpatient visits and 200,000 inpatient days. In fiscal year 1966, preliminary steps will be taken to establish a program for the international exchange of adverse reaction reports through the World Health Organization (WHO). This program, which will involve 8 to 10 countries, will be implemented in fiscal year 1967 when a reporting center within the Bureau is staffed. It will provide a more thorough procedure for the early detection of harmful effects of drugs that are used fairly extensively in one part of the world before reaching this country. To meet all of these responsibilities in the adverse reactions area, the Bureau requests an additional 19 positions for fiscal year 1967, including 11 to staff the WHO reporting center. Medical reference service During fiscal year 1965, the Bureau's medical reference unit was unable to meet half of the requests for services it received. No significant improvements were made in this area during fiscal year 1966 because the high priority science information retrieval area required available resources. An additional nine positions are requested for fiscal year 1967. In addition to staff, an increase of $50,000 is proposed for the purchase of microfilm editions of certain reference works, microfilm reader printers, medical references, and journal subscriptions. Medical evaluation of hazardous substances Information on the hazards of household chemicals and of cosmetics, pesticides, food additives, and accidental drug ingestion is collected, evaluated, and stored within the Bureau for ultimate dissemination to interested activities in the agency. FDA receives about 60,000 injury reports each year, as well as 4,000 certificates of death caused by chemicals, etc. The New York University Medical Center submits over a thousand reports annually on the effects of various household products on the skin. To keep abreast of this data and, equally as important, to develop new sources of information, five additional positions are needed. Science information In fiscal year 1967, an increase of 22 positions is requested for the science information program. These are justified in a special analysis on this program on page 77. 1966 estimate: Positions Amount 1967 estimate: Positions Amount 1967 Increase: Positions Amount Medical resources and liaison 11 $604, 500 42 $1, 112, 000 31 $507, 500 An expanded program for liaison with the medical and scientific community will require additional positions in fiscal year 1967. The Bureau plans to employ the services of more ad hoc committees and more extramural research performers. In addition, the professional development program will be greatly expanded, and positions will be necessary to fill the gap created by the time lost throughout the Bureau. Advisory commillees The advisory committees on investigational drugs and the medical advisory board now meet on a regular schedule and are providing important aid in clarifying basic issues for the Bureau. In general, communications with the scientific and medical community are improving, particularly through the AMA Council on Drugs and through liaison with scientists in PHS and other Government agencies. Eleven medical advisory committees will be appointed in fiscal year 1966, 18 in fiscal year 1967. The use of committees and panels entails a great deal of work in preparing for meetings and distributing committee decisions and recommendations. In addition to two clerical positions available for this work in fiscal year 1966, Bureau professional staff devote portions of their time to the medical details involved. To use their time more effectively, a professional "secretariat" staff is needed in this area: two additional positions are requested. Cooperative research For FDA to determine the safety and efficacy of drugs, access to independent clinical studies conducted in hospital facilities is required. During fiscal year 1965, these studles included investigations of two appetite depressants, various medicated room sprays, and an alleged cancer cure. During fiscal year 1966, $340,000 will be available for clinical studies of other drugs and devices, such as oral contraceptives, anti-infective agents, and psychotherapeutic agents. This program will be continued at the same level in fiscal year 1967. The $320,000 program for a "quick-response" clinical-pharmacological laboratory initiated in fiscal year 1966 in the metropolitan Washington area will also continue at the same level. This laboratory will provide for clinical investigators and facilities to be immediately available on a regular basis for urgent questions that may develop during the processing of IND's, NDA's, litigation on seizures, or upon the report of adverse drug reactions. Recognizing the problems connected with the effect of drugs on the newborn and on genetic functions, the Commission on Drug Safety conceived the idea of a series of workshops on teratology. Two of these workshops have been held to date, both supported by industry grants. These workshops have played an important role in disseminating information on teratology, particularly to workers in the field. FDA proposes to continue this program in fiscal year 1967 by sponsoring two workshops at a total of about $60,000. Two additional positions are requested to aid in implementing all of these cooperative programs in fiscal year 1967. Professional development To maintain and improve the quality of medical and scientific review, the professional staff in FDA must keep in touch with those outside of the Agency who are involved in the same work, and it must maintain a continuous program of postgraduate education. To achieve this end in fiscal year 1967, FDA proposes the part-time assignment of medical and scientific personnel to research and teaching centers at a rate amounting to about 10 percent of professional staff time. To offset the manpower loss in regulatory programs that would result from these aassignments, 22 additional positions are proposed for fiscal year 1967. Medical regulations Experience has demonstrated the need for continuing review and revision of the drug regulations promulgated by FDA. Delayed action in making needed changes in the regulations may adversely affect the public interest, place unnecessary burdens on the staff, and result in hardships to the regulated industries. An Assistant for Medical Regulations has been designated to keep abreast of the need for new and revised regulations. During fiscal year 1966 his activities will be limited to the identification of problem areas and to handling the most urgent regulation changes. An increase of three positions is requested for fiscal year 1967, which will enable this unit to revise and simplify 15 to 20 percent of the new drug regulations and to provide assistance in other important areas, such as the development of regulations for good manufacturing procedures. Drug coordination There has long been a need for a focal point in the Bureau with whom industry representatives could communicate on the status of their submissions to FDA. To meet this need, the position of Assistant for Drug Coordination was created at the time of the 1965 reorganization. This function has been welcomed by the drug industry, and over 60 visits were made in the first several months of operation. Approximately 450 pieces of correspondence were received during the same period. Visits and inquiries are becoming more frequent, and by fiscal year 1967 it is anticipated that the workload in this area will more than triple. To meet the demands expected in this area, two additional positions are requested. |