Options-Average Monthend Open Interest and 12-Month Volume MONDAY, MARCH 26, 1984. FOOD AND DRUG ADMINISTRATION WITNESSES MARK NOVITCH, M.D., ACTING COMMISSIONER OF FOOD AND DRUGS GERALD F. MEYER, ASSOCIATE COMMISSIONER FOR MANAGEMENT AND FRANK P. CLAUNTS, DIRECTOR, DIVISION OF FINANCIAL MANAGEMENT ANTHONY ITTEILAG, DEPUTY ASSISTANT SECRETARY, BUDGET, DEPARTMENT OF HEALTH AND HUMAN SERVICES EDWARD N. BRANDT, JR., M.D., ASSISTANT SECRETARY FOR HEALTH SANFORD A. MILLER, DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FDA MARION FINKEL, M.D., DIRECTOR, OFFICE OF ORPHAN PRODUCTS DEVELOPMENT, FDA LESTER A. CRAWFORD, DIRECTOR, CENTER FOR VETERINARY MEDICINE, FDA Mr. WHITTEN. The Committee will come to order. We have today the Food and Drug Administration. We are glad to have Dr. Novitch and his associates with us today. We are all very much interested in your activities. We are glad indeed to have you. You can proceed in your own way. Anybody new to the Committee, you can introduce them. Dr. NOVITCH. Mr. Chairman, I think Dr. Ed Brandt, who is assistant secretary for health, would like to make some opening comments, and then I will proceed. Mr. WHITTEN. We will be glad to hear from you. [CLERK'S NOTE.-The biographical sketches of the witnesses follow. The full text of Dr. Brandt's statement appears on pages 448 through 453. The full text of Dr. Novitch's statement appears on pages 454 through 461.] MARK NOVITCH, M.D. Position: Acting Commissioner, Food and Drug Administration. Education: Bulkeley School, New London, Connecticut, 1946-50; Yale University, New Haven, Connecticut, A.B., 1954; New York Medical College, Flower and Fifth Avenue Hospitals, New York, N.Y., M.D., 1958; Intern, 1958-59, and Assistant Resident in Medicine, 1959-60, Fifth and Sixth Medical Services, Boston City Hospital; Research Fellow, 1960-62, Assistant in Medicine, 1962-64, and Instructor in Medicine, 1964-67, Harvard Medical School; Assistant in Medicine, 1960-62, and Junior Associate in Medicine, 1962-67, Peter Bent Brigham Hospital, Boston; Assistant Physician to the University Health Services, Harvard University, 1961-67; Private practice of Medicine, Cambridge, Masachusetts, 1963-67; Resident Fellow, Kirkland House, Harvard University, 1964-67; Attending Physician, U.S. Veterans Administration Hospital, West Roxbury, Massachusetts, 1963-67; Assistant to the Deputy Assistant Secretary for Health and Scientific Affairs, and Assistant Staff Director, Task Force on Prescription Drugs, Department of Health, Education, and Welfare, (269) Washington, D.C., 1967-70; Federal Executive Fellow, Brookings Institution, Washington, D.C., 1970-71; Deputy Associate Commissioner for Medical Affairs, FDA, 1971-78; Associate Commissioner for Health Affairs, FDA, 1978-81; Deputy Commissioner, FDA, 1981-1983. Memberships: American Public Health Association, 1959-Present; Massachusetts Medical Society, 1959-Present; Formulary Committee, Harvard University Health Services, 1963-67; Premedical Advisory Board, Harvard University, 1964-67; Medicaid/Medicare Coordinating Committee, HEW, 1969-70; Committee on Medical Device Regulation, HEW, 1969-70; United States Pharmacopeial Convention (Delegate at Large), 1970-Present; Executive Secretary, OTC Drug Review Steering Committee, FDA, 1971-75; Chairman, Maximum Allowable Cost Working Group, HEW, 1973-75; Executive Secretary, Pharmaceutical Reimbursement Board, HEW, 197577; Chairman, Commissioner's Review Team, Panel on New Drug Regulation, FDA, 1977-78; Chairman, Peer Review Committee, Visiting Scientist Program, FDA, 1978-79; Chairman, Consulting Group on Drug Information Exchange, World Health Organization, 1979; Chairman, Performance Review Board, FDA, 1980Present; Executive Resources Board, HHS, 1980-Present; Board of Directors, National Health Council, 1980-Present. Medical licensure: Massachusetts, California, District of Columbia. Civic activities: Volunteer physician, Medical Clinic, Walter Reed Army Medical Center, Washington, D.C., 1968-70; Chairman, Economic Development Committee, Advisory Neighborhood Commission 3F, District of Columbia, 1976-78. Awards: Cor et Manus Award, New York Medical College, 1958, U.S. Public Health Service Fellowship, 1960-62, Secretary's Special Citation, U.S. Department of Health, Education, and Welfare, 1968 and 1975, Commissioner's Special Citation, FDA, 1977, Group Award of Merit, FDA, 1979, Presidential Meritorious Executive Award, 1980, FDA Award of Merit, 1982; Biographee, "Who's Who in America," 1982-83, and Honorary Membership, American Pharmaceutical Association, 1983. THOMAS SCARLETT Position: Chief Counsel, Food and Drug Administration. Education: Columbia University, B.A., summa cum laude, Phi Beta Kappa, 1966 Yale Law School, J.D., Order of the Coif, Yale Law Journal, 1969. Experience: 1981-Present, Chief Counsel, Food and Drug Administration; 19791981, of counsel, Morgan, Lewis & Bockius. Counseling and litigation in food and drug and environmental matters; 1978-1979, Deputy Chief Counsel for Regulations and Hearings, Food and Drug Division of HEW's Office of the General Counsel; 1973-1978, Lawyer, Food and Drug Division of HEW's Office of General Counsel; 1971-1973, Lawyer with the former Social and Rehabilitation Services Division of HEW's Office of the General Counsel; 1969-1971, Associate with White & Case, New York City; 1968, law clerk, Bergman & Barth, New Haven, Conn. Memberships: New York Bar, District of Columbia Bar, United States Supreme Court Bar, and the American Bar Association. GERALD F. MEYER Position: Associate Commissioner for Management and Operations, Food and Drug Administration. Birthplace and date: Maquoketa, Iowa, September 16, 1936. Education: June, 1958, B.S., cum laude, Commerce, University of Notre Dame, South Bend, Indiana. Honors and awards: Senior Executive Service Performance Award-1980 Food and Drug Administration-Award of Merit, May 31, 1973; DHEW Superior Performance Award-May 28, 1968. Experience: April 1979 to Present, associate Commissioner for Management and Operations, Food and Drug Administration; 1978 to 1979, President, Microbiological Associates, a Division of the Wittaker Corporation, Bethesda, Maryland; 1973 to 1978-Associate Commissioner for Management and Operations, FDA; 1972 to 1973-Director, Office of Legislative Services, Food and Drug Administration; 1971 to 1972-Chief, Health Branch, Division of Budget, Office of the Secretary, Department of Health, Education and Welfare; 1969 to 1971-Clerk to the Minority, Appropriations Committee, U.S. House of Representatives; 1964 to 1969-Administrative Officer, Etiology Research Program directed at the Cause and Prevention of Cancer, National Cancer Institute; 1962 to 1964-Administrative Officer, National Institutes of Health, Research Program in West Africa undertaken to assist the Government of Ghana develop its first medical school; 1960 to 1961-Budget Analyst National Cancer Institute; 1958 to 1960-Management Intern, National Institutes of Health. FRANK P. CLAUNTS Position: Director, Division of Financial Management, Office of the Associate Commissioner for Management and Operations. Birthplace and date: Bartlesville, Oklahoma, September 5, 1942. Education: Bachelor of Arts, Texas Tech, June 1964, Master of Business Administration, American University, May 1975. Honors and awards: Food and Drug Administration Commendable Service Award, 1980; Quality Increases in 1975, 1973, and 1971; "Distinction" on MBA Comprehensive Exams in 1975; Special College Leadership Award at Texas Tech in 1964. Experience: July 1980 to Present, Director, Division of Financial Management, Food and Drug Administration; September 1977-June 1980, Director, Division of Management Services, Food and Drug Administration; July-September, 1977, Special Assistant to the Associate Commissioner for Management and Operations, Food and Drug Administration; August 1976-June 1977, Legislative Analyst, Office of Management and Budget; July 1972-August 1976, Management Analyst, Food and Drug Administration; June 1971-May 1972, State Director of the Peace Corps in Bihar, India; July 1969-June 1971 India Desk Officer, Peace Corps, Washington, D.C.; September 1966-July 1969, Peace Corps Field Officer in north-eastern India; June 1964-June 1966, Peace Corps Volunteer, Tripura, India. ANTHONY L. ITTEILAG Position: Deputy Assistant Secretary, Budget, Department of Health and Human Services. Birthplace and date: Westerly, Rhode Island, May 3, 1942. Education: University of Rhode Island, 1964, B.A. (Magna Cum Laude); Graduate Studies at the George Washington University and the University of Maryland. Experience: 1980-Present, Deputy Assistant Secretary, Budget, DHHS; 1978-1980, Director, Division of Budget Policy and Management, DHEW; 1975-1978, Chief, Support Programs Budget Branch, ACTION; 1969-1972, Head, Procurement of Aircraft and Missiles Budget Section, Department of the Navy; 1965-1968, Budget Analyst, Department of the Navy. Honors and awards: 1976, Public Health Service Exemplary Service Award; 1979, 1977, 1976, 1975, 1974, 1972, Incentive Awards; 1979 Senior Executive Service. Memberships: American Association for Budget and Program Analysis; Federal Executive League; International Association of Parents of the Deaf; Southern Proverty Law Center. EDWARD N. BRANDT, JR., ASSISTANT SECRETARY for Health, DepartmenT OF HEALTH AND HUMAN SERVICES Edward N. Brandt Jr. was sworn in May 14, 1981, as assistant secretary for health, Department of Health and Human Services. Dr. Brandt was nominated by President Reagan Feb. 13, 1981, and confirmed by the Senate May 4, 1981. Before joining HHS, Dr. Brandt, a physician, was associated with the University of Texas. Since 1977, he had been vice chancellor for health affairs for the university system, based in Austin. From 1970 to 1977, he was dean of the graduate school, dean of medicine and executive dean of the University of Texas Medical Branch in Galveston. He had also served since 1970 as professor in the university's departments of preventive medicine and family medicine. From 1962 to 1970 Dr. Brandt was at the University of Oklahoma Medical Center, first as director of the Medical Research Computer Čenter and later as associate dean and associate director of the medical center. As assistant secretary for health, Dr. Brandt directs the activities of the Public Health Service, which includes the Alcohol, Drug Abuse and Mental Health Administration; the Centers for Disease Control; the Food and Drug Administration; the Health Resources and Services Administration; and the National Institutes of Health. Dr. Brandt provides policy guidance for other HHS health programs including the Health Care Financing Administration, which administers Medicare and Medicaid. 33-494 0-84--18 |