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Living With Cancer

Advocacy

Position papers from other organizations

  • Position Statement from the National Breast Cancer Coalition. To find its statement, go to www.natlbcc.org and search for "access to investigational interventions". Select "Position Statement on Access to Investigational Interventions Outside of Clinical Trials".
  • Position Statement from Breast Cancer Action
  • 1998 Consensus Statement from the National AIDS Treatment Project regarding expanded access and compassionate use of a specific drug Glaxo-Wellcome's 1592U89 drug, then in development.
  • 1997 Canadian HIV/AIDS Legal Network Analysis of Canadian House of Commons recommendations. October 1996. Spring 1997.

FDA and Congressional Events on Compassionate Use

The FDA held meetings in 2000 and 2001 to discuss the issue of compassionate use. Resources from the meeting include:

  • Briefing document: reviews compassionate use from the regulatory perspective. Technical and informative.
    Slides: Powerpoint presentations from FDA and industry
  • Questions: FDA questions for the advisory panel
  • Transcripts: meeting transcripts:
    Dec. 14, 2000

    June 7, 2001: Part 1/Part 2

The House of Representatives, Committee on Government Reform and Oversight, has held an ongoing series of hearings on the issue of compassionate use. FDA position statements from these meetings spell out regulatory positions and concerns.

  • Statement by Robert J. Temple, M.D., Associate Director for Center for Drug Evaluation and Research, Food and Drug Administration, before the Committee on Government Reform, U.S. House Of Representatives
    June 20, 2001

The transcript for the entire June 20 2001 hearing

Look for hearing transcripts from June 20, 2001. This includes statements from Samuel Waksal of ImClone, Frank Burroughs of the Abigail Alliance and Fred Santino.

  • Statement by Richard Pazdur, M.D. Director, Division of Oncology Drug Products Food and Drug Administration, Department of Health And Human Services, before the Committee on Government Reform, U.S. House of Representatives June 7, 2000
  • Statement by Michael A. Friedman, M.D., Lead Deputy Commissioner, Food and Drug Administration, Department of Health and Human Services, before the Committee on Government Reform and Oversight, U.S. House of Representatives April 22, 1998

FDA Regulations

FDA Guidances

Essays and articles about compassionate use

General information, easy reading

Compassionate Use Resources

By Telephone:

FDA Office of Special Health Issues,
Cancer Liaison Program

(301) 827-4460