BACKGROUND

On March 26, 1996, President Clinton announced the FDA Initiatives on Reinventing the Regulation of Cancer Drugs. This program of cancer initiatives specified the participation of patient representatives on FDA advisory committees that review and consider cancer-related therapies. Between February 14, 1995, and December 16, 1996, eleven non-voting patient representatives have served on FDA advisory committees including the Oncologic Drug Advisory Committee, the Medical Imaging Drugs Advisory Committee, and Biological Response Modifiers Advisory Committee.

On December 13, 1996, Lead Deputy Commissioner for Operations, Michael A. Friedman, M.D., announced that patient representatives would have the full voting privileges of FDA advisory committee members. Since that date, patient representatives have cast votes on 14 different therapies related to cancer, including AIDS- related cancers. The view that patient representatives should serve a fixed term was endorsed by patient representatives who have served to date and supported by comments received during the comment solicitation period following the Federal Register notice dated January 15, 1997.

Prepared by:
Cancer Liaison Program
Office of Special Health Issues
Office of International and Constituent Relations

Last revised March 5, 1998