Senate Bill Seeks to Create Standards Body for Regenerative Medicine

Senate Bill Seeks to Create Standards Body for Regenerative Medicine

Sen. Tammy Baldwin (D-WI) introduced a bill recently to promote the development of regulatory science and standards for regenerative medicine and advanced therapies.

While there is the Regenerative Medicine Promotion Act of 2014,this bill, known as the Advancing Standards in Regenerative Medicine Act, would require the US Food and Drug Administration (FDA) to oversee the creation of a "Standards Coordinating Body" for regenerative medicine. Regenerative medicine and advanced therapies belong to a rapidly growing field of medicine that includes cell therapy, gene therapy and tissue engineering products. To date, FDA's Office of Cellular, Tissue and Gene Therapies (OCTGT) has approved several cell therapies, but has yet to approve any gene therapies, though many hope that that could soon change.

Currently, the vast majority of treatments for chronic and or life-threatening diseases often only delay disease progression and the onset of complications associated with the underlying illness. Very few therapies in use today are capable of actually curing or significantly changing the course of disease. The result is not very promising for patients plagued with these progressive diseases and a healthcare system burdened by costly treatments with few solutions for containing rising costs.

In introducing the bill, Baldwin pointed to a "lack of collaboration on standards development" as a major barrier to regenerative medicine. "The lack of standards is an obstacle to drug development in this field, the creation of a Standards Coordinating Body will support a more coordinated and refined regulatory submission review, reducing the time and financial resources necessary for development and approval of cell and gene therapies and other regenerative medicine therapeutic programs," Michael Werner, executive director of the Alliance for Regenerative Medicine told Focus via email.

If passed, the Standards Coordinating Body would be developed in consultation with industry, academic institutions, standard setting organizations and relevant federal agencies. Notably, the bill does not allocate any additional funding to FDA, so any costs will be taken from FDA's existing budget.

The bill also directs FDA to "identify opportunities for the development of laboratory regulatory science research and documentary standards," both independently and in collaboration with the Standards Coordinating Body. Additionally, the bill calls on FDA to issue additional guidance for sponsors on "how these standards may be used in regulatory review."

Regenerative medicine is a direction in medicine that can help change our current path of passively treating symptoms and the not the core disease or cause itself. Hopefully more bills like these are enacted in order to push the medical industry in the direction it needs to go.

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