The fiscal year 1966 supplemental approved by the Congress in August 1965 provides the initial resources required to establish a new Bureau of Drug Abuse Control, whose overall responsibilities are to develop and execute an effective audit and investigation program; to coordinate and guide the functions relating to drug abuse control that are handled by other FDA units, such as requirements in the fields of education and voluntary compliance, research and development, medical evaluation and field laboratory support; and to coordinate our activities with HEW Department and other Federal and State agencies, and outside institutions and groups in furthering the Bureau's mission to curtail the illegal distribution and abuse of nonnarcotic drugs. FDA's fiscal year 1966 supplemental request was based upon the assumption of a phased buildup of its drug abuse control program. The first phase, contained in the fiscal year 1966 supplemental, establishes the nucleus of a field audit program, strengthens FDA's criminal investigative capabilities, provides for the establishment of five field area offices, and makes provisions for a baise headquarters staff to provide program support under the direction of a new Bureau, the Bureau of Drug Abuse Control. A four-phase buildup is now planned to bring the program to full strength in fiscal year 1969. During fiscal year 1967, FDA proposes to take the second step in widening the scope of its field audit and criminal investigative capabilities by adding several new area offices to its field structure, and at headquarters, supplementing its case assistance staff to guide these operations. 1966 estimate: Positions... Amount 1967 estimate: Positions Amount.. 1967 increase: Positions. Amount... Field programs 244 $1,950, 100 346 $4,619, 900 102 $2,669, 800 Three major elements affect FDA's establishment of field programs and a field structure for the Bureau of Drug Abuse Control: 1. The need for intensive review and surveillance of stimulant and depressant drug production and distribution to detect the diversion of these drugs from legitimate channels. Several factors are of particular importance in this area during fiscal year 1967: The need to audit, within 3 years, all firms required to register and keep records of stimulant and depressant drugs under the drug abuse amendments; the ability to review in depth where evidence and leads indicate the necessity; and the ability to begin spot check and followup operations concerning pharmacies, hospitals, practitioners, etc. 2. The need for increased criminal and undercover operations coordinated with the audit function to provide followup support and investigation of such activities as counterfeiting which are not connected with the legitimate manufacturers or distributors. 3. The need for flexibility and capability to meet varying problems of drug abuse in different socioeconomic and age groups as they are found in different parts of the Nation, and provide field support to FDA's research, medical, educational, and other programs as they pertain to drug abuse control. Audit investigation. The audit provisions of the drug abuse control amendments require that records of receipt and sale of depressant and stimulant drugs be maintained throughout the chain of distribution. Effective February 1966, these records must be available for inspection by FDA for a period of 3 years. FDA's responsibilities in this area are to devise and implement an audit program that will identify the diversion of drugs from legitimate channels. FDA's experience has shown that diversion may occur at the basic chemical level, in dosage form at the manufacturer level, and from wholesalers, pharmacies, hospitals, etc. Current estimates indicate that there are approximately 4,000 establishments that will be required to register under the provisions of the amendments, comprised of 1,600 manufacturers, compounders, and processors; 1,500 wholesale druggists; and 900 jobbers and distributors. FDA has an immediate responsibility to systematically audit these establishments in order to: (a) quickly identify and take action at major points of diversion, (b) review operations, in depth, of those establishments where the initial audit or leads from other sources suggest illegitimate activities, (c) compile production and distribution data that will permit an accurate assessment of the quantities of these drugs produced and their channels of distribution and (d) promote a thorough understanding of the law and a desire on the part of the regulated industry and the public to assist FDA in the curtailment of the diversion and abuse of dangerous drugs. FDA's goal in auditing the 4,000 establishments required to register is to complete an initial audit of all establishments by fiscal year 1969, and at the same time provide for adequate manpower for rechecking and auditing in depth where necessary. In addition to the bulk producers and distributors of psychotoxic drugs, there are approximately 65,000 pharmacies, hospitals, and clinics and 330,000 practitioners and researchers who are the final major link in the distribution chain. In this area, FDA must develop a flexible program of immediate followup and systematic spot checking in order to quickly identify and correct violations and to promote voluntary compliance with the law. During fiscal year 1967, FDA will inspect the records of practitioners, researchers, clinics, pharmacies, and hospitals in those cases where there are specific leads or complaints. It is estimated that in future years routine coverage will be extended to these groups on a spot check basis as well as by followup investigations. The following table shows the estimated manpower required for these audit program goals through the second phase of a proposed four-phase buildup. 1 Effective man-years indicates the amount actually devoted to the audit work after an estimated 8-week training period. Fiscal year 1966 positions are lapsed at 50 percent. Positions cover number required for both initial audit and followup. It is anticipated that coverage of establishments requiring full audit will reach the projected level in fiscal year 1969; greater emphasis will then be given to expanding followup investigations of hospitals, clinics, practitioners, etc., as necessary The man-years required to cover the workload of auditing operations concerning potentially hazardous drugs are calculated from FDA's limited experience with record examinations in this field. Estimates such as 40 hours to audit a manufacturer or 16 hours for pharmacies and clinics were divided into an inspector's actual time available for investigation, exclusive of his training, travel, and administrative time, to determine the number of inspectors necessary to cover the industry in the projected 4 years. These estimated averages may be materially increased by findings of poorly kept or scattered records, illegal activity and requirements for in-depth audits. Support manpower for this operation is 1 supervisor for each 10 inspectors and 1 clerk for each 4 professionals. Actual experience may demonstrate the need for closer supervision and coordination of this operation. To advance the program of audit investigation to assure that all establishments are inspected by fiscal year 1969, a total of 142 positions is proposed for fiscal year 1967 consisting of 106 general investigators, 10 supervisors, and 26 clerks. This is an increase of 46 positions over fiscal year 1966. Criminal investigations.-As with the field audit program FDA's goal in the area of criminal undercover investigations is to achieve a four-phase buildup to be largely completed by fiscal year 1969. This will approximately double the level of effort in investigation achieved in fiscal year 1965 before enactment of the new law. This goal has been based upon the assumption that an effective field audit program will substantially reduce the "easy" diversion of psychotoxic drugs from legitimate channels and thus bring illegal distribution of psychotoxic drugs within workable bounds. If experience shows that the audit investigation curtails the "easy" diversion to our expectation, it is possible that illegal manufacturing and distribution would increase to meet the demand. If so, the level of effort and resources for this program will be reconsidered. The fiscal year 1966 supplemental (including the transfer of BRC positions to this area) provides a total of 119 positions for direct criminal investigative activities. In the second phase of the program, FDA proposes 21 additional positions in fiscal year 1967, consisting of 12 criminal investigators, 5 supervisors, and 4 clerks to bring the ratio of inspectors to support positions to the same level of the audit function. A total increase of $237,000 in nonstaff funds will be required to support the undercover program. This includes $15,000 for criminal investigator pay differential, $19,000 for special equipment purchase, $5,000 for special equipment rental, and $198,0001 for annualization of the cost of several fiscal year 1966 items on a full-year basis. The theoretical breakdown in BDAC field operations into categories of audit and criminal investigations is used to quantify the two major definable methods of approach to the problem of drug abuse on all of its levels from the manufacturer to the abuser. Each investigator will be trained in both operations. He may follow an investigation from the initial lead uncovered during an audit or series of audits or by complaint through to the arrest of the illegal distributors. In this way, an investigation followed through and coordinated by its initiator will not lose the perspective gained in gathering the basic facts since the routine plant audit becomes an investigation as soon as the first clue of diversion is found. This knowledge of the basic data is invaluable. Training. A well-informed and trained field staff is imperative if the new law is to be enforced in an enlightened and effective manner. This staff not only must have a high degree of technical training in investigational procedures and self-defense, but they must also bring to their work a knowledge of the overall problem of drug abuse with which they will be dealing, and an understanding of the complex legal decisions in search, seizure, and arrest. To prepare the investigational and audit staff for their work, an intensive training program will be undertaken, during which new employees will be given a basic orientation to FDA programs and the new law, training in audit and investigative procedures, legal and courtroom procedures, self-defense and disarmament, and an academic course on the sociological and psychological aspects of drug abuse. This comprehensive training program, initiated in fiscal year 1966, will be conducted under contract with one of the country's major universities. The training will be accomplished over an 8-week period. In fiscal year 1966, 150 persons will be trained and during fiscal year 1967, approximately 85 persons will require this training at a total cost of $179,000. Of this amount, $111,000 would be required for tuition, supplies, audiovisual materials, and the remaining $68,000 would be required to pay for travel to and from the training site and to provide per diem compensation for the trainees. Field organization.-The fiscal year 1966 supplemental makes provisions for the resources for the initial establishment of five drug abuse control field offices, with average supervisory and clerical staffing of six positions per office (an area Items annualized are: Informer fees, $63,000; investigator pay differential, $61,000; extraordinary travel, $17,000; special equipment rentals, $10,000; special room rental, $15,000; sample purchases, $120,000; props, $12,000. Items decreased are special equipment purchases, $70,000; and truck rentals, $30,000. The net annualization is $198,000. director, an audit program chief, a criminal investigation program chief, and three clerks). Since the drug abuse problem is nationwide and since effective coordination and economical operation of the drug abuse field program is essential to effective operation, FDA proposes resources to permit the establishment of four new area offices to bring the number of field units to nine in fiscal year 1967. Two new types of positions are requested for the offices established in fiscal year 1966: A chief investigator, who will act as the area director's deputy and who will assist the director in such critical areas as Federal-State liaison and liaison with local enforcement agencies and professional groups: and a hearings examiner for each area to handle the anticipated legal workload. This position is essential to assure that the legal proceedings which result from the uncovering of violations are properly, effectively and expeditiously handled. To accomplish this expansion of field offices and the addition of these new positions to existing resources, 34 positions are proposed, consisting of 22 professional and 12 clerical support personnel. Nonstaff funds required will amount to $278,000, including $147,000 for annualization of fiscal year 1966 costs and $131,000 for new field space rental. The fiscal year 1966 supplemental provided headquarters resources to assure strong and effective leadership during the critical first phase of drug abuse control program development. FDA plans to continue with basically this same staffing component in fiscal year 1967, with the exception of two new positions proposed for headquarters to provide additional staff in the case assistance area to help coordinate the increased legal workloads projected for fiscal year 1967. An amount of $35,000 in nonstaff funds is requested to reimburse the Civil Service Commission for special field background investigations of new professional personnel proposed in fiscal year 1967. This background investigation is essential because of the special nature of drug abuse control work. Agents will carry guns, make arrests, and present cases to U.S. attorneys, thus their character must be beyond reproach. They must be emotionally stable and able to operate under stress. Approximately $27,000 will be required for space rental, including annualization of full-year requirements for fiscal year 1966 positions. Coordination and direction of the various programs of FDA are accomplished in this activity. This activity also contains functions and services that can best be performed on a centralized basis. These include agency administrative services. In addition, technical support to the scientific staff is placed here. This includes the central laboratory services operation and a major portion of the science information program. 60-627-66-pt. 2- -8 The functions within this subactivity include the establishment of policy; the formulation and promulgation of agencywide plans, budgets, regulations, and directives; the allocation of resources; the day-to-day direction of the agency; the dissemination of information to the press and to the public; and, the evaluation of performance and accomplishments. In addition, programs are conducted to promote cooperative Federal-State relations; and to obtain advice from outside consultants. Policy and direction.-The Office of the Assistant Commissioner for Regulations is charged with responsibility for screening all documents on new drugs, and processing and reviewing for approval by the Commissioner all documents proposed for the Federal Register. With the increased emphasis being placed upon preclearance and prevention in enforcement activities, the workload has been expanding over the past several years. By 1967, the workload resulting from new drug and antibiotic regulations will exceed the capacity of the existing staff to handle it on a timely basis, and backlogs will start to accrue. One additional position is requested. The Office of the Assistant Commissioner for Science Resources reviews FDA's research programs and provides a focal point for the coordination of all scientific activities, including the science information program, which is separately justified in a special analysis on page 75. Two important functions of this Office are the coordination and monitoring of cooperative research studies and the upgrading of FDA's scientific manpower. Over $1 million will be awarded in fiscal year 1966 for cooperative research studies, and approximately $2.5 million in fiscal year 1967. To insure that FDA keeps its scientists current in their scientific disciplines, programs are planned that will provide an exchange of scientists between selected universities and FDA, and the rotation of scientists within the agency to broaden their experience. Three positions are requested to coordinate and monitor these programs. Planning and budgeting.-Key to successful development and implementation of consumer protection programs are the planning and budgeting processes. In its first year, fiscal year 1965, the planning staff developed a comprehensive 5-year plan for FDA, which contains the agency's goals and program objectives through fiscal year 1970. The current budget request reflects the agency plan for fiscal year 1967 and anticipates future year requirements. The complexities and continued growth of agency operations has resulted in increased workloads in the planning and budgeting areas. In addition, during the past year it has been necessary to detail personnel on a temporary basis from other units to assist the staff working on FDA's legislative matters. FDA's legislative program will require extensive work by the legislative staff to provide timely assistance in the consideration of draft and pending legisla tion. Three additional positions are requested for these activities. Special programs Three programs are conducted by FDA on a centralized basis, relating to the specialized mission and needs of the agency: emergency preparedness, FederalState relations, and outside consultation. The Special Adviser to the Commissioner handles the arrangements, including financing, of all outside consultation to the agency. These include standing committees such as the National Advisory Food and Drug Council, ad hoc committees to provide specific advice on specific problems, scientific seminars and symposia to discuss important scientific subjects and exchange information and views, and individual consultants retained to advise or to work on special projects. In fiscal year 1966. $200,000 is available for this program. In fiscal year 1967, 5 additional standing committees, 22 additional panels of experts, and an additional seminar are planned. To fund these, an increase of $50,000 is requested. |