Leaders of Breakthrough T1D, the leading global type 1 diabetes (T1D) research and advocacy organization, met today with senior officials at the Food and Drug Administration (FDA) including Acting CDER Director Mike Davis and Acting CBER Director Karim Mikhail. Separately, they also met with Health Resources and Services Administration (HRSA) Administrator Tom Engels, as well as other senior leaders at HRSA to discuss our proposal to reclassify deceased donor islets as organs for transplantation. HRSA is the agency within the Department of Health and Human Services (HHS) responsible for the Organ Procurement and Transplantation Network. Both meetings highlighted Breakthrough T1D’s commitment to working with government agencies to accelerate the delivery of therapies and cures.
“It was my privilege to meet with senior leaders at the Food and Drug Administration and Health Resources and Services Administration today,” said Aaron J. Kowalski, Ph.D. “As I testified recently to the House Energy and Commerce Committee’s Health Subcommittee, FDA plays an important role in safely accelerating breakthrough treatments from the lab to the T1D Community. We’ve already seen positive steps come from Acting Commissioner Diamantas’ leadership, and we appreciate his desire to make FDA the modern, responsive, and reliable partner that American innovation demands.
We discussed some of the most pressing issues facing T1D research today, including deceased donor islet classification as well as the important need for FDA regulatory pathways to keep pace with science, reflect the needs of people living with T1D, and support accelerated development of curative therapies. There are tremendous opportunities for FDA to keep pace with the science. With the right approach, and good partnerships, we will usher in cutting-edge therapies more quickly, effectively, and safely.
There is a lot of incredible work being done, right now, on better therapies and cures for T1D. Delivering on the promise of that science means all of us–FDA, HRSA, researchers, manufacturers, and advocacy communities–working together. We look forward to continuing these invaluable partnerships to accelerate results for everyone living with this disease.”