July 2, 1998

Dear Colleague:

On January 15, 1997, we proposed and solicited comments from the public on a process for selecting patient representatives to serve on the Food and Drug Administration's (FDA) advisory committees that review cancer therapies. We have reviewed and incorporated the comments we received into a final selection process. This process is explained in the enclosed guide. Please review this document carefully.

We invite you to submit your FDA Patient Representative candidate nominations to the following address:

Cancer Liaison Program
Office of Special Health Issues (HF-12)
Food and Drug Administration
Room 9-49
5600 Fishers Lane
Rockville, Maryland 20857

Nominations may be submitted by individuals, patient advocacy organizations, or other organizations. Self nominations will also be considered. After the program is in place, we plan to routinely evaluate the process and make adjustments as needed.

I have enclosed additional background information concerning the FDA's Cancer Patient Representative Program. We believe that involving cancer survivors in the advisory committee process brings a valuable perspective to the review and consideration of new cancer therapies.

We look forward to receiving your nominations, and if you have questions about the process please call JoAnn Minor or Beth Robins at 301-827-4460.

Sincerely,
/s/
Theresa A. Toigo, R.Ph., M.B.A.
Associate Commissioner
for Special Health Issues

3 Enclosures:

Federal Register Notice, January 15, 1997

Nomination Guide

Background

Last revised July 2, 1998