5. Progress Made in Federal Human Nutrition Research Planning and Coordination: Some Improvement Needed-CDE-82-56-5/21/82. 6. Attrition of Scientists At Three Regulatory Agencies-GAO/PAD-83-16-12/ 27/82. 7. Legislative and Administrative Changes Needed to Improve Regulation of Drug Industry-GAO/HRD-82-24-4/7/83. 8. Better Use of Information Technology Can Reduce the Burden of Federal Paperwork-GAO/GGD-83-39-5/3/83. 9. Federal Regulations of Medical Devices-Problems Still To Be OvercomeGAO/HRD-83-53-9/5/83. 10. Monitoring and Enforcing Food Safety-An Overview of Past Studies-GAO/ RCED-83-153-9/9/83. 11. Improvements Needed in Clinical Testing of Anticancer Drugs-GAO/HRD83-52-10/14/83. ACQUIRED IMMUNE DEFICIENCY SYNDROME Mr. WHITTEN. Dr. Brandt, please outline for us the current situation regarding acquired immune deficiency syndrome. Dr. BRANDT. At this time AIDS continues to be a major unsolved public health problem in the United States, with over 3,700 cases having been reported to the Centers for Disease Control. Although research conducted or supported by the Public Health Service has resulted in the identification of several viruses associated with AIDS patients, there are as yet no data to show that any of them alone, or in combination, is the causative agent. The general working hypothesis remains, however, that an infectious agent-probably a virus-is the cause of AIDS, and we will continue to support research efforts to find the cause of AIDS. Mr. WHITTEN. Dr. Brandt, are you currently considering more vigorous FDA regulation of blood bank organizations? Dr. BRANDT. Last year, we discussed the fact that the scientific evidence linking blood and blood products to AIDS was only suggestive. Although there have been more data to suggest a link between blood and certain plasma derivatives with AIDS, we remain unable to identify individuals whose blood may be at risk because the causative agent of AIDS has not been identified and a test specifically for AIDS has therefore not been developed. There have been discussions of alternate approaches to laboratory screening tests which might be applied to blood plasma donors, and pilot studies are already under way to explore their feasibility and reliability. There is general agreement within the blood community that if one of those tests proves to be satisfactory in terms of identifying individuals who are at risk for AIDS, the rest would be used on a voluntary basis without the need for FDA to impose it by regulation. In the meantime, I continue to believe that our interim measures are appropriately directed at educating groups at increased risk of harboring AIDS to the potential danger of others if they donate blood or plasma. Our goal is to protect the quality of blood and blood products without imposing procedures or regulations which would disrupt the nation's blood supply to the extent that it would be harmful to the large number of persons who need transfusions. LOSS OF KEY PERSONNEL Mr. WHITTEN. With regard to the loss of key personnel, please update the table which appears on page 487 of the last year's hearing. [The information follows:] FDA KEY PERSONNEL LOSSES Reason/new employer fiscal year 1979 1980 1981 1982 1983 1. Department of Health and Human Services 2. 3. National Institutes of Health... Center for Disease Control... Health Care Financing Administration.... Alcohol, Drug Abuse, and Mental Health Administration Subtotal.. Other Government agencies: Department of Agriculture. Department of Defense. National Aeronautics and Space Administration.. Agency for International Development Veterans Administration..... Office of Management and Budget. Subtotal.. Nongovernment: American Critical Care.... American Journal of Tropical Medicine and Hygiene.. Association of Analytical Chemists. Blood Systems Inc... Clement Associates. Consulting.. Department of Health, Virginia. Farming.. Grocery Manufacturing. Howard University... Institute for Drug Development. Ledase Limited... M & D Technology (Scotland). Millipore Corp.... National Academy of Science National Food Processors. New York Medical College.. P/T Consultant (regulated indus. trade ass.). Patton, Boggs & Brow. Science Applications. Self-employed... Siemens Association. Spiral Systems... Squaw Peak Anesthesia Service. Stanford University.... Systems Automation Corp. The Nutrition Foundation. University of California. Mr. WHITTEN. What is the current status of Japanese regulation of BHA? Dr. NOVITCH. Representatives of the Japanese Government advised us that they were going to propose to ban BHA in September 1983. We reviewed their data and told them that we did not believe the data were conclusive. We further requested that the data be reviewed by scientists from the U.S., Canada, and the United Kingdom, as well as Japan. The recommendation of the scientists reviewing the studies was that additional studies should be conducted. The Joint Expert Committee on Food Additives of the World Health Organization/Food Agricultural Organization has reviewed data on BHA and concurred with the findings and recommendation of these scientists. As a result of that recommendation, various studies have been initiated in the U.S., Canada, and the United Kingdom. The Japanese Government subsequently decided not to propose a ban on BHA pending the outcome of these studies. Mr. WHITTEN. Dr. Brandt, Please quantify the total resources in the Public Health Service devoted to the National Toxicology Program, and identify the various components of these resources in 1983, 1984, and 1985. Mr. WHITTEN. Dr. Brandt, please provide for the record the total amount expended by PHS for drug development in 1979, 1980, 1981, 1982, 1983, and your plans for 1984 and 1985, separately identifying the amounts expended by the Centers for Disease Control, the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, and the Food and Drug Administration. [The information follows:] The amounts expended by the Public Health Service in Fiscal Years 1979 through 1983 and estimate amounts for 1984 and 1985 are as follows: |