December 8, 2016
What is the news?
Both the House and Senate have passed the 21st Century Cures legislation, which President Obama has said he will sign into law.
- provides more than $4.8 billion over 10 years to the National Institutes of Health (NIH) for the Precision Medicine Initiative, Cancer Moonshot, BRAIN Initiative, and regenerative medicine using adult stem cells.
- provides the FDA with $500 million over 10 years to move drugs and medical devices to patients more quickly, while maintaining safety and effectiveness standards.
- encourages HHS to carry out a “Precision medicine Initiative” to augment efforts to address disease prevention, diagnosis, and treatment.
Why does it matter?
- $1.5 billion of the funds will fund research to advance precision medicine.
- $1.8 billion will fund cancer research.
- The legislation supports broader, more collaborative development, qualification, and utilization of biomarkers that help assess how a therapy is working earlier in the process.
- The Cures Act includes creation of a “Next Generation of Researchers Initiative” in the Office of the NIH director to improve opportunities for new researchers.
- The act also establishes a review pathway at FDA for biomarkers and other drug-development tools that can be used to help shorten drug-development time and reduce the failure rate in drug development.
- …and more.
What is SNMMI doing?
- SNMMI plans to submit comments to the Centers for Medicare and Medicaid Services regarding the site-neutral policy that is included in the Cures Act. The society will work with other medical societies and stake-holder groups on these comments.
- SNMMI is working to help streamline the FDA regulatory approval process for new and existing radiopharmaceuticals.
President Obama is expected to sign the Cures Act. A stop-gap funding bill being developed on the Hill is expected to include some initial funds.
Links to more information
HHS: 21st Century Cures—Key Documents
Cures Fact Sheet
Section-by-Section Summary of the Cures Act
SNMMI article on House passage of the Cures Act