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The Legislation Directs the U.S. FDA to Facilitate the Establishment of a Standards Coordinating Body in Regenerative Medicine and Advanced Therapies, as Well to Support the Efforts of the Coordinating Body in the Development and Implementation of Material and Process Standards
WASHINGTON, DC--(Marketwired - Mar 4, 2016) - The Alliance for Regenerative Medicine (ARM) is pleased to announce U.S. Congressman Bill Foster (D-IL) has introduced the Advanced Standards in Regenerative Medicine Act, the House companion bill to S.2443 introduced by U.S. Senator Tammy Baldwin (D-WI) in January.
"We applaud Senator Baldwin's and Congressman Foster's leadership in promoting the need for industry-wide standards in this sector," said Michael Werner, executive director of ARM. "The Standards Coordinating Body, which this legislation supports and recognizes as an effort to bring much-needed planning and cooperation to the standards development effort, will expedite the creation of life-saving cell therapies, gene therapies and other regenerative medicine products."
The legislation directs the U.S. FDA to facilitate the establishment of a Standards Coordinating Body in Regenerative Medicine and Advanced Therapies, as well to support the efforts of the coordinating body in the development and implementation of material and process standards essential to the timely advancement and approval of new regenerative therapies to treat major unmet medical needs.
When introducing the Senate legislation in January, Senator Baldwin stated, "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."
As the only Ph.D. scientist currently serving in the U.S. Congress, Congressman Foster has been a longtime supporter of the life science industry. In his recent release, Representative Foster noted, "Regenerative medicine is an exciting new field that holds the possibility to transform treatments and outcomes for patients. 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."
ARM is working to ensure the legislation is included in the Senate's Medical Innovation package, currently under development.
About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 240 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org.