News Details
NCCN Statement on FDA Leadership and Vision for the Future
[Fort Washington, PA – April 5, 2017] The Food and Drug Administration (FDA) plays a critical role in the ability for patients to benefit from medical progress and safe and effective scientific breakthroughs. As such, the FDA requires a leader who will ensure that evidence-based, sound decision-making is preserved so that patients can live better lives.
The National Comprehensive Cancer Network® (NCCN®), an alliance of 27 leading academic cancer centers in the United States, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. As such, NCCN believes that high-quality cancer care depends on safe and effective products for patients, which are then reflected in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), and compendia, such as the NCCN Drug & Biologics Compendium (NCCN Compendium®), that patients, providers, and commercial and private payers utilize to make treatment and coverage policy decisions. In turn, NCCN looks forward to working with the future FDA Commissioner to ensure that as therapies and products are approved, NCCN can continue to promote the importance of continuous quality improvement through updates to the NCCN Guidelines, NCCN Compendium, and other derivative products.
Specifically, NCCN hopes to work with the next commissioner to pursue this goal as the agency implements the 21st Century Cures Act and seeks to reauthorize important programs this year. In addition, NCCN hopes the following will be priorities of the new leadership:
- Emphasize stable, consistent funding to continue to reduce review times and thus improve access for patients: According to researchers at the Tufts Center for the Study of Drug Development, the time required for the FDA approval phase of new drug development (i.e., time from submission until approval) has been cut from an average of 2.0 years for the approval phase at the start of PDUFA to an average of 1.1 years more recently.
- Provide important guidance to industry: Just as NCCN provides valuable evidence and guidance to patients, clinicians, and payers, the FDA provides a large body of technical guidance to industry that clarifies the drug development pathway for many diseases and meets with companies during drug development to provide critical advice on specific development programs.
- Promote appropriate care opportunities for patients with cancer, including preventive opportunities (such as strong regulation of tobacco and related products through the Center for Tobacco Products), clinical trial access and availability, and accelerated approval for rare diseases.
Consistent with these goals, Robert W. Carlson MD, Chief Executive Officer of NCCN praises the nomination of Scott Gottlieb, MD, to serve as the next FDA Commissioner. “We deeply respect Dr. Gottlieb’s experience in health care and particularly his experience with the issues that patients with cancer and providers face, and we look forward to working together to accomplish the goal of high-quality cancer care for all Americans.”
For more information about NCCN’s oncology policy initiatives and to view comment letters and statements sent by NCCN, visit NCCN.org/policy.
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