CU and EAP Resources
Position papers from other organizations
top of the page- 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
top of the pageThe 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. Click here for 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
top of the page- “Treatment use of an investigational new drug"
Code of Federal Regulations, Title 21, Part 312, Subpart B, Section 312.34
The regulations guiding FDA on compassionate use
FDA Guidances
top of the page- “Expanded Access of Investigational Drugs
Guidance for Institutional Review Boards and Clinical Investigators"
1998 Update - “Emergency Use of an Investigation Drug or Biologic
Guidance for Institutional Review Boards and Clinical Investigators"
1998 Update
Essays and articles about compassionate use
top of the page- “Demand Grows for Early Access to Promising Cancer Drugs” Joyce Baldwin, Journal of the National Cancer Institute, Vol. 94, No. 22, 1668-1670, November 20, 2002 (subscription required)
- “Merciful Medicine” by Jerome Groopman, MD. Groopman is a professor at the Harvard Medical School and chief of experimental medicine at Beth Israel Deaconess Medical Center. He has written extensively for both medical journals and the popular press. "Merciful Medicine" is his essay about compassionate use. Jerome Groopman (Harvard Medical School), "Merciful Medicine," New Republic, April 26-May 3, 1999 (subscription required)
- 1996 Article from Mathew Lovell, Food and Drug Law Journal "Second Thoughts: Do the FDA's Responses to a Fatal Drug Trial and the AIDS Community's Doubts About Early Access to Drugs Hint at a Shift in Basic FDA Policy?"
- David A. Nass Jr. Memorial Foundation The story of David's struggle for compassionate use and an analysis of how cancer advocates should mimic the HIV/AIDS advocates in their fight against cancer.
General information, easy reading
top of the page- "Access to Cancer Drugs World Wide," Kidney Cancer Association
- "Experimental Treatments? Unapproved but Not Always Unavailable"
FDA Consumer magazine, Jan-Feb 2000 - "Access to Unapproved Drugs" FDA information on compassionate use
- "Understanding Clinical Trials" NCI information on clinical trials. Check out "Q & A: Access to Investigational Drugs" and "Understanding the Approval Process for New Cancer Drugs"
- "Expanded Access of Investigational Drugs
Guidance for Institutional Review Boards and Clinical Investigators"
1998 Update
Compassionate Use Resources
top of the pageBy Telephone:
FDA Office of Special Health Issues,
Cancer Liaison Program
(301) 827-4460