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A proposal for FDA reform

Abstract

Since the current system for the regulation of drugs in the United States was established in 1962, the FDA has steadily increased the scope of its responsibilities and activities, and, concomitantly, the regulatory burden on drug developers. The costs and time that are required for drug development have spiralled upwards. Reform of drug regulation is necessary; it must be fundamental in nature, and it must come from outside the agency through new legislation.

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References

  1. 1

    US Food and Drug Administration. About the US Food and Drug Administration. US Food and Drug Administration [online] (cited 20 Jun 2002) 〈http://www.fda.gov/opacom/hpview.html〉 (2002).

  2. 2

    US Food and Drug Administration. The Federal Food, Drug and Cosmetic Act. As Amended by the FDA Modernization Act of 1997. US Food and Drug Administration [online] (cited 20 Jun 2002) 〈http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm〉 (1997).

  3. 3

    US Food and Drug Administration. The Public Health Service Act. US Food and Drug Administration [online] (cited 20 Jun 2002) 〈http://www.fda.gov/opacom/laws/phsvcact/phsvcact.htm〉 (1999).

  4. 4

    Boston Consulting Group. The Contribution of Pharmaceutical Companies: What's at Stake for America (Boston Consulting Group, Boston, 1993).

  5. 5

    Peck, C. C. Drug development: improving the process. Food Drug Law J. 52, 163–167 (1997).

    CAS  PubMed  Google Scholar 

  6. 6

    Anon. in Pharmaceutical Research and Manufacturers of America, 1999 Industry Profile 33 (PhRMA, Washington DC, 1999).

  7. 7

    DiMasi, J. A. et al. Cost of innovation in the pharmaceutical industry. J. Health Econ. 10, 108–142 (1991).

    Article  Google Scholar 

  8. 8

    Anon. Tufts Center for the study of drug development pegs cost of a new prescription medicine at $802 million. Tufts Center for the Study of Drug Development [online] (cited Jun 22 2002) 〈http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=6〉 (2001).

  9. 9

    Pharmaceutical Research and Manufacturers Association. New Drug Approvals (Pharmaceutical Research and Manufacturers Association, Washington DC, 1998).

  10. 10

    Grabowski, H. G. & Vernon, J. M. Returns to R&D on new drug introductions in the 1980s. J. Health Econ. 13, 383–406 (1994).

    CAS  Article  Google Scholar 

  11. 11

    Miller, H. I. Ill-advised response to a tragedy. Financial Times 11 (14 January 2000).

  12. 12

    Fletcher, L. Cubist highlights FDA's antibiotic resistance. Nature Biotechnol. 20, 206–207 (2002).

    CAS  Article  Google Scholar 

  13. 13

    Anon. The Tufts University Center for the Study of Drug Development, 1996–1997 Annual Report (Tufts University, Boston, 1997).

  14. 14

    Testimony of Michael K. Kirk on H.R. 400 before the House Subcommittee on Courts and Intellecutal Property (American Intellectual Property Law Association, Arlington, Virginia, 1997).

  15. 15

    US Centers for Disease Control and Prevention. Viral hepititis B. US Centers for Disease Control and Prevention [online] (cited 20 Jun 2002) 〈http://www.cdc.gov/ncidod/diseases/hepatitis/b/index.htm〉 (2002).

  16. 16

    Bakke, O. M., Wardell, W. M. & Lasagna, L. Drug discontinuations in the United Kingdom and United States: issues of safety. Clin. Pharmacol. Ther. 35, 559–567 (1984).

    CAS  Article  Google Scholar 

  17. 17

    Bakke, O. M., Manocchia, M. A., de Abajo, F., Kaitin, K. I. & Lasagna, L. Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: a regulatory perspective. Clin. Pharmacol. Ther. 58, 108–117 (1995).

    CAS  Article  Google Scholar 

  18. 18

    US Food and Drug Administration. Improving Public Health Through Human Drugs (US Food and Drug Administration, Washington DC, 2001).

  19. 19

    FY 2003 Justification of Estimates for Appropriations Committees. FY 2003 Budget Summary. US Food and Drug Administration [online] (cited 20 Jun 2002) 〈http://www.fda.gov/oc/oms/ofm/budget/2003/BIB2003.pdf〉 (2002).

  20. 20

    Goldberg, R. M. Breaking up the FDA's medical information monopoly. Regulation Magazine [online] (cited 20 Jun 2002) 〈http://www.cato.org/pubs/regulation/reg18n2c.html〉 (1995).

  21. 21

    Miller, H. I. & Wardell, W. M. in Advancing Medical Innovation: Health, Safety and the Role of Government in the 21st Century (eds Epstein, R. A. et al.) 41–69 (Progress & Freedom Foundation, Washington DC, 1996).

    Google Scholar 

  22. 22

    Testimony of Pamela Walker, Mitre-Tek Systems, before the Committee on Labor and Human Resources of the US Senate (Committee on Labor and Human Resources, Washington DC, 1996).

  23. 23

    EU Commission Council Directive 93/42/EEC (1993).

  24. 24

    Epstein, R. A. in Advancing Medical Innovation: Health, Safety and the Role of Government in the 21st Century (eds Epstein, R. A. et al.) 70–96 (Progress & Freedom Foundation, Washington DC, 1996).

    Google Scholar 

  25. 25

    PhRMA. PhRMA Industry Profile 2002 — Chapter 2. Pharmaceutical Research and Manufacturers of America [online] (cited Jun 2002) 〈http://www.phrma.org/publications/publications/profile02/chapter2.pdf〉 (2002).

  26. 26

    Biotechnology Industry Organization. Biotechnology Industry Statistics. Biotechnology Industry Organization [online] (cited 20 Jun 2002) 〈http://www.bio.org/er/statistics.asp〉 (2002).

  27. 27

    Peltzman, S. Miller's Prescription. Regulation 24, 56–57 (2001).

    Google Scholar 

  28. 28

    Bandow, D. The FDA can be hazardous to your health. The Cato Institute [online] (cited Jun 2002) 〈http://www.cato.org/dailys/1-29-97.html〉 (1997).

  29. 29

    Anon. Bravo, FDA (Really). Wall Street Journal (3 June 2002).

  30. 30

    Miller, H. I. To America's Health: a Proposal to Reform the Food and Drug Administration (Hoover Institution Press, Stanford, California, 2000).

    Google Scholar 

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Correspondence to Henry I. Miller.

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FURTHER INFORMATION

Centers for Disease Control and Prevention

Council on Competitiveness

Duke University

European Agency for the Evaluation of Medicinal Products

FDA

Hoover Institution

Johns Hopkins Center for Clinical Trials

Joint Commission on Accreditation of Healthcare Organizations

Medicines Control Agency

National Institutes of Health

Occupational Safety and Health Administration

Office of Management and Budget

Tufts Center for the Study of Drug Development

Underwriters Laboratories

University of Chicago

University of Pennsylvania

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Miller, H. A proposal for FDA reform. Nat Rev Drug Discov 1, 642–648 (2002). https://doi.org/10.1038/nrd874

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