genetic changes; implementing organizational changes to emphasize and focus on cancer therapeutics; among others; and, in general, balancing its role as a consumer protection agency with its obligation to make useful medications available to the marketplace and patient care on a timely basis.
Both agencies are responding to the promise and challenges posed by advances in basic and clinical science in cancer and related fields and the need to adjust strategies and programs to this progress in scientific understanding.
Both agencies have issued statements and taken steps to coordinate, collaborate, and cooperate with the objective of ensuring that the potential of recent and projected scientific progress in cancer is translated to new anticancer therapeutics that are less toxic, more specific to precise molecular targets, and more effective in tumor control. NCI and FDA collaborations and continuing work to update procedures and policies for drug identification and development appear to be encouraging directions for the future. The information reviewed in this background paper, however, suggests that scientific, procedural, and policy problems remain that will require continuing effort from these agencies, singly and in concert, if their goals in the fight against cancer are to be realized in the most efficient and effective directions.