Mar 02, 2017
In December 2016, President Barack Obama signed into law the 21st Century Cures Act, landmark legislation designed to improve and accelerate the pace of biomedical research in the United States. The bill passed Congress with overwhelming bipartisan support, with a House vote of 392 to 26 and Senate vote of 94 to five.
ASCO CEO Clifford A. Hudis, MD, FACP, FASCO, attended the White House signing ceremony to witness the culmination of 3 years of intensive advocacy effort by ASCO and its members.
“This historic legislation brings new hope to millions of Americans facing life-threatening diseases and to their families,” said Dr. Hudis. “Not only does the 21st Century Cures Act reduce some of the major barriers to advancing cancer research, the measure also provides critical authority to federal research agencies to accomplish major priorities for the cancer community, including the Cancer Moonshot and Precision Medicine Initiatives.”
ASCO was a major supporter of the Cures Act and worked with lawmakers to advocate for key priorities—many of which were included in the final legislation. These priorities include:
- Addressing the interoperability of electronic health records (EHRs) and restricting intentional information blocking to make it easier to coordinate patient care and advance big data and precision medicine efforts.
- Authorizing supplemental funding for the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) to support critical cancer research and accelerate the momentum of the Cancer Moonshot and Precision Medicine Initiatives.
- Requiring drug companies to make available public information about their expanded access plans after phase II and phase III clinical trials so that patients and providers can more easily get access to promising new treatments.
- Improving the way research is conducted by requiring the use of centralized Institutional Review Boards when appropriate, encouraging data standardization, and bringing the patient voice into the drug development process.
The 21st Century Cures Act also includes additional provisions of interest to ASCO members, including providing a site neutrality exemption for certain cancer center outpatient departments, increasing transparency around the Local Coverage Determination Process, advancing guidance on incorporating novel clinical trial design into new drug applications, and authorizing funding for states to address the opioid crisis, among other measures.
Passage of the legislation was quickly followed by Congress fully funding the 21st Century Cures Act for Fiscal Year 2017 in a continuing resolution signed into law at the end of 2016. The spending bill included $872 million for Cures, of which $352 million is supplemental NIH funding to support the Cancer Moonshot Initiative. Funding is also provided to the FDA to carry out new responsibilities included in the Cures legislation.
“Enacting 21st Century Cures is a momentous achievement and, potentially, an important pivot point for cancer research progress,” said Dr. Hudis.
ASCO will continue to work with the new administration and Congress to build on this achievement and ensure NIH and the National Cancer Institute are adequately funded to further our progress against cancer.
Visit ASCO in Action (ascoaction.asco.org) for the latest news on ASCO’s health care advocacy efforts.