Introduction: Science and Government in Drug Development, Regulatory Assessment, and Postmarketing Surveillance
The papers included in this volume--like the international meeting from which they are taken--all deal to some extent with the roles of, and relationships between, science and government in the development and use of prescription drugs. The purpose of this introduction is to survey the current nature of government participation, and to identify changes and future trends in the impact of both science and government.
KeywordsFederal Register Orphan Drug Relative Efficacy Marketing Approval Reagan Administration
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- 1.Irving I. Kessler, “Putting Reason Into Regulation” (Rochester, N.Y.: Center for the Study of Drug Development, Publication Series, PS 7705 ), pp. 1–7.Google Scholar
- 2.U.S. Congress, House of Representatives, A Bill to Expand the Medical Freedom of Choice of Consumers by Amending the Federal Food, Drug, and Cosmetic Act to Provide That Drugs will be Regulated Under That Act Solely to Assure Their Safety, H.R. 14426, 94th Congress, 2nd Session, 1976, pp. 1–3.Google Scholar
- 3.Department of Health, Education and Welfare, Food and Drug Administration, “New Drug Regulations Under the Federal Food, Drug and Cosmetic Act,” Federal Register 35: 7250, 8 May 1970.Google Scholar
- 4.Regulations proposed under the Bioresearch Monitoring Program by the FDA include: 1. Department of Health, Education and Welfare, Food and Drug Administration, “Obligations of Clinical Investigators of Regulated Articles,” Federal Register 43:35210, 8 August 1978. 2. Department of Health, Education and Welfare, Food and Drug Administration, “Obligations of Sponsors and Monitors of Clinical Investigations,” Federal Register 42:29412, 7 September 1977. Final regulations include: 1. Department of Health, Education and Welfare, Food and.Drug Administration, “Non-clinical Laboratory Studies: Good Laboratory Practice Regulations,” Federal Register 43:59986, 22 December 1978. 2. Department of Health and Human Services, Food and Drug Administration, “Protection of Human Subjects; Informed Consent,” Federal Register 46:8942, 27 January 1981. 3. Department of Health and Human Services, Food and Drug Administration, “Protection of Human Subjects; Standards for Institutional Review Boards,” Federal Register 46:8952, 27 January 1981. The last two of these “final” regulations are scheduled to go into effect 27 July 1981 but the Reagan administration has indicated there may be some delay in implementation.Google Scholar
- 5.For example, the stringencies of the Bioresearch Monitoring Program regulations may result in a further paucity of clinical investigators in the U.S. and further encourage the move abroad of clinical studies. See “Statement of the American Society for Clinical Pharmacology and Therapeutics on the Drug Regulation Reform Act of 1978 (H.R. 11611)” submitted to the Subcommittee on Health and the Environment of the House Committee on Interstate and Foreign Commerce, 22 June 1978 (presented on 27 June 1978), pp. 8–9.Google Scholar
- 6.William M. Wardell, ed., Controlling the Use of Therapeutic Drugs: An International Comparison ( Washington, D.C.: American Enterprise Institute, 1978 ).Google Scholar
- 7.For the expression of government concern, see National Immunization Working Groups, Reports and Recommendations, submitted to the Office of the Assistant Secretary for Health, McLean Virginia, 15 March 1977. For an elaboration, see the “Introduction” in William M. Wardell, ed., Controlling the Use of Therapeutic Drugs: An International Comparison ( Washington, D.C.: American Enterprise Institute, 1978 ).Google Scholar
- 8.For elaboration, see, for example, U.S., Department of Health, Education and Welfare, Significant Drugs of Limited Commercial Value: Report of the Interagency Task Force to the Secretary of H.E.W. by Marion J. Finkel (29 June 1979) and Fred E. Karch, ed., Orphan Drugs (New York: Marcel Dekker, in press). Recently, widespread concern has been expressed about this issue. Hearings were held on 9 March 1981 by the House Health Subcommittee, for example. Testifying before the House HHS Appropriations Subcommittee March 24th, HHS Secretary Schweiker expressed “‘personal’” concern that “‘something’” be done including “‘some role for federal research.’” [As quoted in FDC Reports (The Pink Sheet), 30 March 1981, p. TandG 16.]Google Scholar