An ecosystem that supports innovation—including federal regulatory, reimbursement and research policies—is critical to the success of JDRF’s mission. For many years, JDRF has worked with key decision makers and staff within the Federal Government to foster an environment that will help advance type 1 diabetes (T1D) research.
Specifically, our regulatory efforts are focused on ensuring that therapies for T1D have clear and reasonable regulatory pathways. This is accomplished through engagement with the Food and Drug Administration (FDA) officials on regulatory expectations for specific types of therapies, but also through engagement on overarching issues common to many therapies for T1D and other diseases.
The 21st Century Cures Act (H.R. 34) – approved this week by the U.S. Senate, and last week by the U.S. House of Representatives, with overwhelming bipartisan support – will help accelerate the discovery, development and delivery of life-changing therapies. JDRF provided input and comments throughout the legislative process with this bill. The legislation benefits medical research and patients broadly and includes provisions that will help give patients access to therapies sooner. A few key components of the bill that could support JDRF’s regulatory goals include:
- Making patient input a greater factor in FDA’s regulatory decisions
- Establishing an FDA review pathway for biomarkers and other drug development tools
- Enabling novel clinical trial designs in the regulatory process
- Increasing the scientific expertise at the FDA by improving processes to recruit and retain needed personnel
- $500 million for FDA over a 10-year period to accomplish the key components mentioned above and many others
These changes, plus the work JDRF is doing every day engaging directly with the FDA, have the potential to accelerate the development and approval of life-changing T1D therapies.
The Cures legislation also includes important provisions related to research policies, including appropriated funding for the Precision Medicine Initiative, brain and cancer research, and training the next generation of scientists. The bill is expected to be immediately signed into law by the President.
JDRF is grateful for Congress and the Administration’s continued commitment to advance medical research. JDRF looks forward to working with Congress and the incoming Administration to implement these provisions, while we also work to renew the Special Diabetes Program (SDP) next year.