The Division of Biologics Standards (DBS) is responsible for assuring the standards of potency and safety of a variety of immunizing agents and diagnostic and therapeutic biological products including blood and blood products for use in human beings. "Potency" means that the products are indeed capable of eliciting the bodily reactions or other effects that they are purported to do. "Safety" means that they will exercise their prophylactic, diagnostic or therapeutic effect without inducing undue toxic reactions in the individuals to whom they are administered. The Division's mission encompasses two objectives: 1) Development of standards and requirements, incorporating the necessary guidelines for potency and safety, for biological products to be administered to the general public by practitioners of medicine. The Division functions in a positive way to assure the quality of products, rather than merely policing traffic in biologics. The aim is to further the application of the new materials to public health and medical practice, at the same time assuring conformance to the best standards for safety and potency applicable on the basis of current knowledge. Standards for safety are enforced by a system of periodic inspections of operations and records and the testing of products when necessary of all establishments that are licensed to sell or exchange biological products, including human blood for transfusion, across State lines. 2) Research on important problems relating to all aspects of production, distribution, use and effects of biological products, insofar as these are concerned with safety, purity and potency. CONTROL The basic instrument for the control of "biological products" provided in the Public Health Service Act is that of licensing. The legal requirement for licensing a biological product is that a license may be issued only upon a showing that standards designed to insure the continued safety, purity, and potency of the product have been met. Both the product and manufacturer are subject to licensing. Once an establishment has been licensed, it is inspected each year to determine continued compliance with standards. In addition, samples and test reports of each batch or lot of a product the manufacturer proposes to distribute are required to be submitted to the Division in the case of all but a few products where this is not deemed necessary for the assurance of safety, purity and potency. Test reports are checked; samples are tested when necessary. The lot in question is not distributed until a letter of authorization or release is issued by the Division. During a recent 12-month period over 36,000 control tests were performed by Division personnel on the 3,559 lots submitted for release. This gives no idea of the total effort involved, however, since tests requiring a few minutes are given the same weight as those taking a month or more to complete. The control activities of the Division require, also, the maintenance of a large number of different standard and reference materials. These are prepared in the Division or obtained by purchase. They are all tested in the Laboratories of DBS and distributed as needed. During fiscal 1966, over 7,000 such preparations were sent out to commercial establishments, health departments, universities and research organizations. During 1966, thirty-four members of the scientific staff performed the required annual inspections. Sixty-five scheduled inspection trips were completed covering 236 licensed establishments, 103 locations, 134 blood donor centers as well as 10 applicants for an establishment license, for a total of 483 inspections. INVESTIGATIONS Investigations, in contrast with licensing and inspections, are conducted by the inspectors in the Office of the Director with assistance from laboratory staff when needed for peak loads. Inspections call for the expenditure of predictable periods of time on the part of the people involved and can thus be carried out with minimum dislocation of their other duties. Investigations, on the other hand, are essentially "open ended" with respect to time and must therefore be carried out by people who have this duty as their main function. During 1966 the legal actions and investigations of possible violations of the Public Health Service Act involved a total of 243 man work days on travel status. One hundred and eighty man work days were devoted to consultations with state and federal officials, criminal trial preparation and participation, and witness interviews. The remaining 63 man work days on travel status were spent visiting both licensed and unlicensed establishments for enforcement purposes. RESEARCH The research activities of the Division cut across many disciplines and fields of interest. New and important techniques in immunochemistry must be exploited in relation to investigations of the induction of antibodies by vaccines, the measurement of various types of antibodies, the relation of the antibodies to protection against disease, and the relation of cellular mechanisms as well as antibodies to the entire immune mechanism. New techniques in virology have placed Division scientists in the forefront of knowledge in regard to viral oncogenesis and to means of measuring attentuation of virus strains for the preparation of vaccines. Advances in virology are leading rapidly towards the development of new viral vaccines for mumps, para-influenza, rubella (German measles), respiratory syncytial virus, and many others. The unique features of each of these vaccines relative to the pathogenicity of the virus, the culture system, the techniques for assuring absence of adventitious agents, the inactivation techniques, the tests for safety, lack of communicability, and freedom from neurovirulence, etc. require the attention of expert staff. DBS scientists, to be effective, keep constantly aware of research advances and design their own research activities so as to be prepared for control and testing problems which inevitably come before new or improved products can be entered into general use. Occasionally, because their own work towards these goals provides leads to products, DBS scientists produce an experimental immunogenic agent of their own. This happened recently in the course of work on rubella which was mentioned at last year's hearings. The scientists are continuing their investigative work on the experimental rubella vaccine and are making very desirable progress. This product has been distributed to interested researchers in the scientific community for additional study. It is hoped by all concerned that a safe, pure and potent vaccine will be available to the public within a reasonable time. The same research team has recently developed a simple, rapid and inexpensive hemagglutination inhibition test for rubella antibodies. It is presently engaged in further perfecting this test, the widespread use of which could speed up work on rubella. 1967 AND 1968 PROGRAM PLANS Within the last year the contracts program, stimulated by findings obtained within the last few years of the tumor-producing capabilities of various viruses, has been organized into a series of testing and research projects designed to answer problems of oncogenesis (the production of tumors) in relation to biological products. Work has already been initiated on tests of viral vaccines in the conventional test systems. Various studies are under way on methods for the detection of latent viruses in tissue culture cell preparations used for vaccine production, on adjuvant preparations purported to enhance immunogenicity of vaccines, and on chemicals added to inactivate viruses or to stabilize biologicals. Many of these, because of the inherent nature of the problems, are long-range projects which will require at least several years for their final results. Some of these projects will require the production and use of newborn animals, which in the case of monkeys and dogs, will entail a considerable expenditure. Furthermore, in the analysis of cell chromosomes for example it will be necessary to exploit automated methods to the extent they are available, and possibly to invest in the development of additional graphic analysis techniques. The initial expenditures of funds for this program were, of necessity, committed relatively late, because the conceptual development of a coordinated program of research and testing required a large percentage of the time and effort of Division staff. The program is gaining momentum, and there will be need for additional funds for additional projects and for confirmatory tests and tests of many new combinations of ingredients not included in the first protocols to obtain the precise information required. The "state of the art" in the entire field of viral and chemical oncogenesis is advancing so rapidly on many fronts that there is little doubt that new findings will require new investigations to assure the safety of biological products in these respects. In this budget, an additional $300,000 is requested to further the oncogenic program. The Division has acquired additional facilities in 1967 and present space will be renovated in 1968; the budget contains no provision for additional funds or positions to expand the present staff. However, with expansion of physical facilities, the Division's scientists will have more desirable working conditions which will contribute to productivity. Of the $260,000 requested for equipment, $175,000 is required to equip renovated space in the present building and $85,000 is for specialized research equipment. The 1968 total request is $60,000 less than the total obligations and balance in 1967. The unobligated balances resulting from the reserve in 1967 are $229,000, which, if removed from the base leaves a net increase requested for obligations only of $169.000. This net increase includes $560,000 for the expansion of programs as described above, $24,000 for mandatory items such as annualization of positions new in 1967 and annualization of the wage board pay increase, $184,000 for centrally furnished services from the National Institutes of Health Management Fund, offset by decreases of $7,000 for one day less of pay in 1968 and $592,000 for non-recurring items budgeted in 1967 to equip new facilities and renovate existing space. FRIDAY, APRIL 7, 1967. NATIONAL CANCER INSTITUTE WITNESSES DR. KENNETH M. ENDICOTT, DIRECTOR, NATIONAL CANCER INSTITUTE DR. JAMES A. SHANNON, DIRECTOR, NATIONAL INSTITUTES OF HEALTH ROBERT E. LEARMOUTH, EXECUTIVE OFFICER, NATIONAL CANCER INSTITUTE DR. CARL G. BAKER, ASSOCIATE DIRECTOR FOR PROGRAM, NATIONAL CANCER INSTITUTE EARLE L. BROWNING, BUDGET OFFICER, NATIONAL CANCER INSTITUTE RICHARD L. SEGGEL, EXECUTIVE OFFICER, NATIONAL INSTITUTES OF HEALTH CHARLES MILLER, FINANCIAL MANAGEMENT OFFICER, NATIONAL INSTITUTES OF HEALTH DR. WILLIAM H. STEWART, SURGEON GENERAL G. R. CLAGUE, ACTING CHIEF FINANCE OFFICER JAMES B. CARDWELL, DEPUTY ASSISTANT SECRETARY, BUDGET 1 Includes capital outlay as follows: 1966, $1,231,000; 1967, $1,447,000; 1968, $2,046,000. Selected resources as of June 30 are as follows: Unpaid undelivered orders, 1965, $44,836,000; 1966, $50,049,000; 1967, $50,049,000; 1968, $50,049,000. BIOGRAPHICAL SKETCH OF PRINCIPAL WITNESS Name: Kenneth Milo Endicott, M.D. Position: Assistant Surgeon General, Public Health Service Director, National Cancer Institute. Birthplace and date: Canon City, Colorado, June 6, 1916. Education: A.B., University of Colorado, Boulder, 1936; M.D., University of Colorado, Denver, 1939. Experience: Director, National Cancer Institute, National Institutes of Health, U.S. Public Health Service, Department of Health, Education, and Welfare, July 1960Appointed Assistant Surgeon General, U.S. Public Health Service, January 1960. Associate Director, National Institutes of Health, 1958-1960. Chief, Cancer Chemotherapy National Service Center, National Cancer Institute, 1955-1958. Scientific Director, Division of Research Grants, National Institutes of Health, 1951-1955. Chief, Section on Metabolic and Degenerative Diseases, Division of Pathology, National Institutes of Health, 1942–1951. Medical Center for Federal Prisoners, Springfield, Missouri, 1942. |