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Foster, Baldwin Introduce Legislation To Support Regenerative Medicine

Mar 3, 2016
Press Release

Washington, DC – Today, Congressman Bill Foster (D-IL) introduced the Advancing Standards in Regenerative Medicine Act to help foster innovation in regenerative medicine, a burgeoning field that holds potential for more targeted medical treatments for chronic and life-threatening diseases. The bill is the House companion to S.2443, introduced by Senator Tammy Baldwin (D-WI) in January.

This bill would require the U.S. Food and Drug Administration (FDA) to create a coordinating body to identify standards that could aide in the successful development of regenerative medical treatments for patients.

“Regenerative medicine is an exciting new field that holds the possibility to transform treatments and outcomes for patients,” said Rep. Foster. “But as in most scientific endeavors, coordination and building on others’ research is essential. Sir Isaac Newton famously said, ‘If I have seen further, it is by standing upon the shoulders of giants.’ Increasing coordination in setting standards will help this developing field grow.”

“We applaud Congressman Foster’s recognition of the need for industry-wide standards in the important and transformative field of regenerative medicine,” said Michael Werner, executive director of the Alliance for Regenerative Medicine. “Establishing the Standards Coordinating Body will enable more efficient and successful development of durable, potentially life-saving gene and cellular therapies and other 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. This measure would help facilitate coordination and leadership as we address the most acute needs for standards and best practices, which will help enable more efficient and successful development of regenerative and other advanced therapies for patients,” said Senator Baldwin, who introduced the legislation in the Senate (S.2443).

Regenerative medicines are cellular therapies, gene therapies, and tissue products, such as skin substitutes to treat diabetic foot ulcers to the more advanced cellular therapies currently being studied that may help treat cardiovascular disease. There are currently over 500 clinical trials ongoing in regenerative medicine worldwide, but the lack of coordination around standards development for these products is an obstacle to robust drug development and approval.

The Advancing Standards in Regenerative Medicine Act would direct the FDA to:

  • Facilitate establishment of a public-private Standards Coordinating Body (SCB) in Regenerative Medicine;
  • Work with appropriate stakeholders, including regenerative medicine manufacturers, clinical researchers, academic institutions, standard setting organizations, and the National Institute of Standards and Technology, in creating the SCB;
  • Participate in the SCB by identifying opportunities for laboratory regulatory science research and helping to develop standards that would support the development, evaluation, and review of regenerative medicine products; and
  • Issue guidance on how standards developed by the SCB may be used in FDA regulatory review for regenerative medicine and advanced therapies.