requirements of premarketing proof of safety and efficacy, as well as accurate labeling and manufacturing control. Please feel free to adapt any of the above requests, in the event that securing any particular answer may pose an unnecessarily time-consuming burden. In addition, please send whatever portions of your response can be rapidly com piled, in advance of a final answer to other parts. In am sending copies of this letter to the Department of Defense and the Pub lic Health Service in order that (a) they may be appropriately informed, and (b) they may supplement your answer with comparable information as to their internal experiences and needs for safe and effective medical devices and equipment. Sincerely, HUBERT H. HUMPHREY, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, April 3, 1964. DEAR SENATOR HUMPHREY: Thank you for your letter of March 6, 1964, re questing information regarding the Public Health Service's experience in pro curement of safe and effective medical devices and equipment and the exter of our cooperation and coordination with other Federal medical agencies meeting common problems in this area. Medical equipment items are not stocked by the PHS. We have agreement with the Veterans Administration and the Department of Defense under which medical equipment stocked in their depots is available for purchase by PE facilities. In view of the availability of most common-use items from the depots and Federal supply contracts, consolidated procurement within PHS our normal requirements has not been found advantageous. The VA depot have become our primary source of medical equipment. Trial-use tests and evaluations of new equipment are performed in our ba pital programs. Such tests, however, are conducted on a very small scale be cause of fund limitations. We receive information of VA and DOD tests experiences by receipt of their Supply Letters and Technical Medical Bulleta and through informal communications. As a result of our evaluations and ordination with the other Federal medical programs, we have had few proble with unsatisfactory equipment. As you are aware, an Intra-Governmental Advisory Council on Drugs ba been established to provide for interchange of procurement information an through cooperative efforts, to improve the quality of these products furnishe Federal agencies. In addition, we have established a PHS Supply Liais Officer position to provide close coordination and cooperation with the othe Federal agencies in supply support. In my opinion, there is a real need for the proposed statutory authority the Food and Drug Administration to require, on a pre-marketing basis, scientif evidence of the safety and effectiveness of medical equipment and devis The need for the legislation would appear much greater in nongovernment acti ties than in Government activities because information of impartial tests a evaluations of medical equipment is not generally available to them. I appreciate this opportunity to express my views in this matter. Sincerely yours, LUTHER L. TERRY. VETERANS ADMINISTRATION, OFFICE OF THE ADMINIStrator of VETERANS AFFAIRS, Washington, D.C., April 20, 1964 DEAR MR. CHAIRMAN: This is in reply to your letter of March 2, requesting written statement from the Department of Medicine and Surgery with respe to VA's problems and experience in procurement of safe and effective medi equipment and devices, etc. We understand that this material is to be used your committee in its study of "efficiency and economy" in "interagency coordi tion" and related matters. In the 17 years which have elapsed since World War II, the VA Supply Program has purchased thousands of items of equipment and supply at a cost in excess of two and a half billion dollars. The incident mentioned in your letter with respect to the procurement of automatic X-ray film processors known as Rapi-Dex was an unfortunate one. Our preliminary review of this matter indicates that our policies for procurement and contract administration are basically sound; however, it is apparent that the safeguards in these policies were not observed in the incident mentioned. In this instance, our critical need for compact, economical and fast X-ray film developing equipment resulted in hasty action and inattention to routine procurement practices. Fortunately, this is not typical of Veterans Administration procurement operations, generally. Nevertheless, I have ordered a study of this matter with a view to preventing future recurrence of such hasty action. It is standard procedure for the Veterans Administration to coordinate its problems and experiences in the procurement of safe and effective medical equipment and devices with other Federal agencies with similar interests. Mutual exchanges of information concerning safety, as well as efficiency, of our drugs and medical supplies are routine. In our judgment, this is beneficial and to a substantial degree meets the requirements of the Government for making full use of its available talent, knowledge and experts in this field. For convenience, the items which follow refer to the similarly identified topics on page 2 of your letter. a. Generally, it is our policy to test new items considered for central purchases and distribution under actual working conditions in Veterans Administration hospitals or clinics. If scientific or laboratory tests are required, we use the facilities of the Bureau of Standards, the Food and Drug Administration, our own service and reclamation shops, and available commercial sources. Important in this area are the quality control systems of manufacturers in performing their own tests and providing us with documented information from recognized testing laboratories of good repute. This generally is adequate and satisfactory for the protection of the Federal interests. b. We are always mindful of the safety and efficiency of equipment and other Items used in the Veterans Administration. Our pre-award inspection and testing of surgical and medical products and apparatus are extensive. For many of our commodities, a Veterans Administration team makes on-site factory inspections to establish minimum standards for subsequent production and purchase, in accordance with the specifications of our own experts in this field. For much of our equipment purchases, actual working installations at hospitals are inspected by qualified Veterans Administration technical personnel for compliance with specifications. Also, we evaluate prototype models of equipment at the manufacturers' plants prior to production. We consistently emphasize close coordination with other Federal agencies in the development of improved specification standards for equipment. There is also a continuous exchange of information between the professional and supporting levels of the Federal agencies. We believe that such procedures are beneficial in our efforts to protect the Government's interest. c. Our experience in purchasing medical equipment and devices is such that in those rare instances when a product fails to meet our minimum specifications such deficiencies are quickly identified. This system is called our Material Quality Improvement Report. The volume of deficient reports over the period of 1 year are so infinitesimal that they would not justify the routine maintenance of a list of the infrequent manufacturer or supplier of such items. When problems do arise, our specifications are revised or amended to overcome the deficiency noted. This procedure, we believe, has generally been most effective. d. The Department of Health, Education, and Welfare has assigned a permanent liaison contact with the Department of Medicine and Surgery. We also have a mutual arrangement with the Department of Defense which calls for joint plant inspection, and exchange of data or information on product quality routinely. e. We assume your inquiry relates to the need for legislation such as S. 2580, a bill to amend the Federal Food, Drug, and Cosmetic Act to extend certain authorities of the Food and Drug Administration. We favor the practice of premarketing evaluation and testing of new medical supplies and equipment. We are aware, of course, that in his message of February 5, 1964 (House Document 220) the President recommended certain additional authority for the Food and Drug Administration and it is our understanding that the subject bill was intro duced to implement this recommendation. We are, however, not in a position to discuss the details of such legislation and must therefore defer to the Department of Health, Education, and Welfare as to such matters. f. The proposed legislation would affect approximately an additional $25 mil lion of our annual local station purchases. When this is added to the value of the items currently tested or inspected by VA, FDA, and the USDA, the total affected could approximate $100 million in total annual purchases. J. S. GLEASON, Jr., Administrator. EXHIBIT 295 U.S. DEPARTMENT OF AGRICULTURE: RELATIONSHIPS WITH FOOD AND DRUG AD MINISTRATION UNDER INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT Principal issues involving the U.S. Department of Agriculture in conjunction with the Food and Drug Administration are being considered separately by the subcommittee in its study of environmental hazards, under the active chairmanship of Senator Abraham Ribicoff. As an illustration, however, of one of but many drug phases involving the two agencies, there follows an exchange of correspondence with USDA. The Honorable ORVILLE L. FREEMAN NOVEMBER 1, 1963. DEAR MR. SECRETARY: Enclosed is an excerpt from a letter received today from a drug manufacturer. He raises a question as to a joint liaison committee between USDA's Plant Pest Control Division and the Food and Drug Administration. I would appreciate receiving a response in duplicate, containing comments by the Department. Sincerely, HUBERT H. HUMPHREY, EXCERPTS OF LETTER FROM DRUG COMPANY (The company official cites the instance of a drug which comes under the jurisdiction of the Food and Drug Administration, since it is used for livestock and poultry. The drug is also used as a larvicide, however, and therefore comes under control of the Pesticide Division of USDA.) The official then states: "The regulations for the enforcement of the Federal Insecticide, Fungicide and Rodenticide Act, state, under 'Interpretations,' that a joint liaison committee would be set up between the Plant Pest Control Division and the Food and Drug Administration with frequent consultations. However, in our dealings with these two agencies, we have never run across this committee, and must deal with each agency independently. This of course places us in a very untenable and precarious situation. We think the law should be completely clear that the committee must be set up and must act on such problems and in no case, e12 either agency take any action except through this committee. This would clarify this situation beyond a shadow of a doubt." UNITED STATES DEPARTMENT OF AGRICULTURE, Washington, D.C., November 19, 1963. DEAR SENATOR HUMPHREY: This is in reply to your letter of November 1, 1963, addressed to Secretary Freeman with an attached excerpt from a letter you received from a drug manufacturer. The interpretations of the regulations for the enforcement of the Feders! Insecticide, Fungicide, and Rodenticide Act which was referred to in the excerpt is interpretation 3 entitled, "Interpretation of Terms Included in Definition of Economic Poison." This interpretation was revised and brought up to date a little over a year ago. A copy of the revision which was published in the Fedral Register on October 6, 1962, is enclosed. The statement referred to in the excerpt is found in paragraph (c), which reads as follows: "To avoid conflict in the requirements under the Federal Insecticide, Fungiide, and Rodenticide Act and the Federal Food, Drug and Cosmetic Act, with respect to products which are covered by both Acts, close liaison is maintained between the Pesticides Regulation Division and the Food and Drug Administration." If, during the review of labeling submitted in connection with the registration of an economic poison, it is found that the product is intended for use in such a manner as to make it subject to both the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug and Cosmetic Act, the scientists reviewing the labeling will consult the appropriate official in the Food and Drug Administration. This is to determine the status of the product under the new drug provisions or the necessity for referring the registrant to the Food and Drug Administration for a further review of his proposed usage. In the same manner, it is common practice for Food and Drug Administration workers to contact Pesticides Regulation Division as to the status of a drug product under the Federal Insecticide, Fungicide, and Rodenticide Act. These exchanges of information are normally carried out informally by telephone. There is no formal committee to handle such matters and it is felt that the formation of such a committee would be difficult. The United States Department of Agriculture has proposed a formal memorandum of understanding, however, to guide officials in both agencies in such mutually important matters. We trust this information will be helpful to you. Sincerely yours, R. J. ANDERSON, Deputy Administrator. EXHIBIT 296 U.S. DEPARTMENT OF AGRICULTURE: ITS REVIEW OF CHEMICAL APPLICATIONS FOR DIAPER RINSES-AN ILLUSTRATION OF AN AREA OF OVERLAPPING INTEREST WITH THE FOOD AND DRUG ADMINISTRATION There follow materials relating to one area which illustrates overlapping of interest between the U.S. Department of Agriculture and the Food and Drug Administration-review of applications for diaper rinses. U.S. DEPARTMENT OF AGRICULTURE, DEAR SENATOR HUMPHREY: As was agreed in a telephone conversation on March 6, 1964, with Mr. Julius Cahn, Staff Director of your Subcommittee on Reorganization, we are appending hereto reviews on: 1. The status of TCC as an antibacterial agent and a diaper additive under the Federal Insecticide, Fungicide, and Rodenticide Act, and the experiences of the Pesticides Regulation Division in regulating products containing this chemical; 2. Procedures for reviewing labeling of products carrying recommendations for use on diapers submitted for registration under the Federal Insecticide, Fungicide and Rodenticide Act; and 3. The problem of overlapping authority in the regulation of laundry chemicals under the Federal Insecticide, Fungicide and Rodenticide Act and the Federal Food, Drug and Cosmetic Act. As was also requested, we are appending to these three reviews: Exhibit A.-Photocopies of some reports from the medical literature on difficulties encountered in the use of TCC on diapers. Exhibit B. A general list of selected references to reports in the medical literature on the use of various chemicals in the treatment of laundry and infant diapers. Exhibit C.-Photocopies of certain announcements sent out by the American Academy of Pediatrics and the American Hospital Association to their members alerting them to the possibility of difficulty in the use of products containing TCC in laundering diapers. Exhibit D.-Copies of certain publications reviewing the history of the reg ulation of sterilizers, germicides, disinfectants, and sanitizers under the Federa Insecticide, Fungicide, and Rodenticide Act. Sincerely yours, Enclosures * 7. JUSTUS C. WARD, Director. REVIEW NO. 1 THE STATUS OF TCC AS AN ANTIBACTERIAL AGENT AND AS A DIAPER ADDITIVE UNDER THE FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT, AND THE EXPERIENCES OF THE PESTICIDES REGULATION DIVISION IN REGULATING PRODUCTS CONTAINING THIS CHEMICAL TCC (3,4,4-trichlorocarbanilide) is manufactured and sold by the Monsanto Chemical Company, Saint Louis, Mo., for use as an antibacterial additive for toilet soaps, laundry detergents and laundry rinse chemicals. A manufacturer's label for the basic chemical has been registered under the Federal Insecticide, Fungicide and Rodenticide Act, Registration No. 524-133. The current labeling includes a specific recommendation against use of this product in chemicals en ployed in laundering articles which are sterilized with steam under pressure prior to use. This chemical was first introduced as an antibacterial agent for toilet ber soaps in 1956, and has been employed in many leading brands including Dial and Zest since that time. Acceptance has been largely as a replacement for part the hexachlorophene or other bis-phenol employed to reduce the incidence of skin irritation without loss of efficacy. Acceptance as an additive for toilet bar soaps, which are not subject to the provisions of the Federal Insecticide, Fungicide and Rodenticide Act since they are used solely on or in the living body of man or other animals, was soon fo lowed by introductions into laundry detergents, rinse additives and softeners Since the antibacterial activities claimed in these uses were in the inanimate laundered items, products of this type were classified as economic poisons as that term is defined in the Federal Insecticide, Fungicide and Rodenticide Act at were required to be registered with the Department of Agriculture. By June of 1962, 13 products had been registered for laundry use whid contained TCC at concentrations ranging from 0.5 percent to 5.0 percent of the formula. On June 20, 1962, the Pesticides Regulation Division received a repor that use of a product or products containing TCC in the laundering of diapes subsequently used on premature infants had resulted in the development of t cyanotic condition known as methemoglobinemia. On June 21, 1962, the divisite contacted the Monsanto Chemical Company. This company, pending further investigation, immediately withdrew the basic chemical from the market and ad vised through its Medical Director, Dr. Kelley, the American Hospital Associs tion, and the American Academy of Pediatrics of the apparent danger in the use of laundry products containing this additive. As a direct result of the warning special notices were sent out on June 25, 1962, to all members of these two organizations warning them of the possible danger in the use of produc containing TCC on nursery linens. Investigations by the division's field repre sentatives and employees of the Monsanto Chemical Company at the Cedars of Lebanon Hospital, Los Angeles, Calif., and the Nellis Air Force Base Hospita Las Vegas, Nev., revealed that the product implicated was not registered under the Federal Insecticide, Fungicide and Rodenticide Act and had been shippe illegally in interstate commerce. On the basis of nonregistration 3 interstab shipments were intercepted and seized and the manufacturer, the Calusa Chen cal Company, called back all other outstanding merchandise which was seized. Of the 7,750 pounds of the offending product, Steri-Fleece, which ba been manufactured, all but 533 pounds was accounted for. Company represents tives believed that part of this was lost during packaging and part diverted int nonlaundry applications. *EDITOR'S NOTE: For reasons of brevity, material from the open literature is not r printed with the above letter. |