The development of regenerative medical treatments is one of the most exciting aspects of modern medicine. In fact, a recent report from the U.S. Government Accountability Office states, “virtually any disease that results from malfunctioning, damaged or failing tissues may be potentially cured through regenerative medicine treatments.”
These treatments, developed from adult stem cells, show potential to fully restore or establish normal function in damaged human cells, tissues, or organs.
Currently, the Food and Drug Administration oversees the development of regenerative applications based on a patchwork of regulations. The FDA simply does not have an approval process in place to best consider these new, innovative therapies. As a result, other countries, particularly Japan and the United Kingdom, are quickly outpacing the United States in the development of regenerative treatments.
I introduced the REGROW Act, which addresses the lack of FDA standards in the regenerative treatment field by creating standards that will lead to regulatory predictability regarding manufacturing processes and controls, and ensures the safety of these treatments. The legislation also protects approval pathways under sections 351 and 361 of the Public Health Service Act, while creating a new category for regenerative treatment products.
I think every American has lost a loved one to cancer or other deadly diseases. It’s devastating. That’s why I have introduced this bill and have made it one of my priorities in Congress to support the kind of medical research that seeks cures to prevent these heartbreaking losses.
I’m pleased to have the support of both Republicans and Democrats on this important legislation. Fighting and defeating diseases that devastate families is not a partisan issue, it’s an issue we can all support together.