The FDA's regulation of health economic information

Health Affairs

Volumn 19, Issue 5, 2000, Pages 129-137

  Neumann, Peter J ^a,b   Claxton, Karl ^b,c   Weinstein, Milton C ^b,d  

^a Department of Health Policy ^*

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF YORK   (United Kingdom)

^d Prog Economic Eval Med Technol   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG INDUSTRY; DRUG INFORMATION; ECONOMICS; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEALTH INSURANCE; HUMAN; LEGAL ASPECT; MOTIVATION; ORGANIZATION AND MANAGEMENT; PATIENT ADVOCACY; PHARMACOECONOMICS; RESEARCH; REVIEW; STATISTICS; UNITED STATES;

DRUG INDUSTRY; DRUG INFORMATION SERVICES; ECONOMICS, PHARMACEUTICAL; EVIDENCE-BASED MEDICINE; HEALTH POLICY; HUMANS; MANAGED CARE PROGRAMS; MOTIVATION; PATIENT ADVOCACY; RESEARCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0034268940     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.19.5.129     Document Type: Article

References (13)

1. P.J. Neumann and E.A. Sandberg, "Trends in Health Care R&D and Technology Innovation," Health Affairs (Nov/Dec 1998): 111-119.
2. D. Kessler and W. Pines, "The Federal Regulation of Prescription Drug Advertising and Promotion," Journal of the American Medical Association 264, no. 18 (1990): 2409-2415.
3. Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, "Principles for the Review of Pharmacoeconomic Promotion," Draft Guidelines, 1995. The guidelines noted that "models to provide estimates of pharmacoeconomic parameters should be used only when it is impractical or impossible to gather data using adequate and well-controlled trials."
4. P.J. Neumann, D.E. Zinner, and A.D. Paltiel, "The FDA and Regulation of Cost-Effectiveness Claims," Health Affairs (Fall 1996): 54-71.
5. Federal Trade Commission, Bureau of Economics and Consumer Protection, In the Matter of Pharmaceutical Marketing and Information Exchange in the Managed Care Environments: Public Hearings, Docket no. 95N-0228 (Washington: FTC, 16 January 1996).
6. Ibid.
7. Pharmaceutical Research and Manufacturers of America, comments on Section 114 of FDAMA, submitted to the FDA (Washington: PhRMA, 1998).
8. PhRMA, comments on Section 114 of FDAMA.
9. FTC, In the Matter of Pharmaceutical Marketing, cited in PhRMA, comments on Section 114 of FDAMA.
10. PhRMA, comments on Section 114 of FDAMA.
11. PhRMA, comments on Section 114 of FDAMA.
12. D. Dranove, "Is There Underinvestment in R&D about Prevention?" Journal of Health Economics 17, no. 1 (1998): 117-127.
13. Merrill, "Modernizing the FDA."