U.S. Senator Tammy Baldwin Introduces Bill to Support Regenerative Medicine

WASHINGTON, D.C. – U.S. Senator Tammy Baldwin has introduced legislation that would direct the U.S. Food and Drug Administration (FDA) to facilitate the establishment of a public-private Standards Coordinating Body (SCB) in Regenerative Medicine. The Advancing Standards in Regenerative Medicine Act also directs FDA to participate in developing such standards and to issue guidance on how these standards could be used in FDA review of regenerative medicine products.

“Regenerative medicine holds incredible potential to give us lifesaving therapies for serious diseases. But, the lack of collaboration on standards development today is a huge obstacle as we work to boost the development of these advanced therapies. I’m proud to introduce this legislation that will help facilitate coordination and leadership as we address the most acute needs for standards and best practices, which will enable more efficient and successful development of regenerative and other advanced therapies for patients,” said Senator Baldwin.

“This bill emphasizes Senator Baldwin’s continued leadership in promoting potentially life-saving treatments and cures possible via regenerative medicine and advanced therapies technologies,” said Michael Werner, executive director of the Alliance for Regenerative Medicine. “Establishing industry-wide standards is a crucial step towards streamlining the processes that will enable life-saving products to be developed with greater speed and efficiency.  The creation of a Standards Coordinating Body will reduce the costs and time necessary to bring safe and effective products to patients in need.”

Regenerative medicines are cellular therapies, gene therapies, and tissue products, and represent a growing field that holds the potential for more targeted medical treatments for chronic and life-threatening diseases. Thanks to the pioneering and breakthrough stem cell research by Dr. James Thomson, Wisconsin is home to a strong base of scientists and innovative companies pursuing regenerative medicine research and product development.  

To help foster innovation and truly grow this evolving industry, stakeholders, researchers and the FDA need to come together on best practices, and basic technical and process standards. Regenerative medicine sponsors must show the FDA that products are safe and effective, including the ability to reliably and reproducibly manufacture products. This is a major challenge for products with the same biological activity. The more sophisticated the process, the greater the need for standardization, assay validation and harmonization. Coordinating basic standards are the first step to spurring innovators, getting more advanced therapies into the pipeline and into the hands of patients in need.

The mission of the SCB is to work with federal agencies, standards organizations, and other stakeholders to create a central authority for the coordination, development support, communication and implementation of technical and process standards for the regenerative medicine industry. Both FDA and innovators will benefit by having standardized measurement processes from which to evaluate products.