The National Coalition for Cancer Survivorship (NCCS) submitted comments to the House Energy and Commerce Committee on its 21st Century Cures legislative initiative. In our comments, we urged that the 21st Century Cures effort reflect a goal of ensuring delivery of appropriate treatment to each patient, based on a shared decision-making process. To achieve the goal of the right medicine for the right patient at the right time in an age of targeted therapies, we strongly recommend that the cancer care experience begin with a cancer care planning encounter between patient and physician. Shared decision-making will be especially critical in an age of precision medicine, when appropriate diagnosis, including genetic profiling, will be necessary to match patient and drug.
We also commented on the committee’s efforts to accelerate Food and Drug Administration (FDA) review so that patients receive promising new treatments at the earliest possible time. We highlighted the need to balance speed of review with the quality and quantity of data required for approval and noted that patients need the reassurance that drugs approved by FDA are in fact safe and effective. The cancer drug review office has achieved an impressive level of efficiency that might be replicated by other review offices. Because we have observed the accomplishments related to cancer drug review – including approval of many products well in advance of their user fee dates – we are not persuaded that fundamental revisions of review processes or changes in evidence required for approval are necessary.
In addition, NCCS joined colleagues in the Cancer Leadership Council in addressing a number of key concepts and provisions in the legislation, including:
- Balancing the speed of regulatory review against an assurance that new cancer drugs are safe and effective;
- Preparing for review of precision medicine drugs;
- Ensuring that “patient-focused drug development efforts” are reflected in the Food and Drug Administration’s programs and regulatory approaches;
- Encouraging the consideration of patient-reported outcomes data in the review process;
- Building data-collection and sharing efforts on a firm foundation of successful clinical trials data reporting;
- Defining the new roles of patient advocacy and patient research foundations in the therapeutic development process; and
- Ensuring that new commissions, panels, and reports serve the needs of patients, do not duplicate existing commissions and reporting requirements, and do not create unreasonable burdens for federal agencies.
View the Comments Submitted by NCCS (also embedded below)