NCCS Policy Comments: Recommending Cancer Survivorship as a Topic for FDA Patient-Focused Drug Development Meetings
Last week, NCCS submitted comments to the U.S. Food and Drug Administration (FDA) regarding the series of patient-focused drug development meetings that have been convened and the list of disease topic meetings scheduled for 2016-2017. In 2013, FDA convened a patient-focused drug development meeting related to lung cancer and has plans to convene a breast cancer meeting in 2015. For 2016-2017, the FDA has identified ovarian cancer and melanoma as possible topics among a list of other disease areas.
While we commend FDA for their efforts to date, we strongly recommend that cancer survivorship be selected as a topic as it meets the criteria that the agency has identified for qualifying as a meeting topic. In addition, the issues identified by cancer survivors and their caregivers would inform therapy development and the regulatory review of new cancer therapies. They may also offer an important perspective regarding assessment of the impact on therapies on quality of life.
Lastly, we recommend that the series of meetings that will consider drug development in specific disease areas be coordinated by, or at least fully involve, the relevant review office. For example, in the case of meetings related to cancer, we propose that the Office of Hematology and Oncology Products assume a key role in organizing the meeting. We believe that this structure would lead to meetings of high quality with strong agendas, ensure that the findings of the meetings inform regulatory activities, and encourage appropriate meeting follow-up.