BOX 6-1

The Impact of Patient Advocacy for Cancer Therapeutics at FDA

Until recently, patient communities were concerned principally with improving research capacity at NIH in their efforts to advance cancer care, according to Ellen Sigal. The role of FDA, on the other hand, remained unclear and thus ignored. The cancer research community has since come to understand the critical functions of FDA in the emergence of new therapeutics for cancer. The community also observed that more could be done to promote cancer care at FDA—beginning with the elevation of oncology to a new office within the agency infrastructure.

In July 2005, the cancer community, including professional groups, cancer centers, scientists, the American Society of Clinical Oncology, and the American College of Radiology, succeeded in bringing about the agency’s Office of Oncology Drug Products (OODP). OODP uniquely encompasses both small-molecule drugs and biologics within one office in an effort to consolidate oncology regulations and improve consistency in review standards and policies, and serves as a small-scale example of flourishing regulatory science.

In going forward, Sigal observed that OOPD could further advance regulatory science by enhancing collaboration among the different FDA centers, increasing interactions with other health-related federal agencies, expanding external advisory capacity, and harmonizing with international regulatory bodies.


SOURCE: Sigal, 2009.



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