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What it does 

The aim of the bill is to establish private public partnerships with stakeholders in the field in an effort to identify opportunities for development of laboratory regulatory scientific research documentation standards.

This is accomplished by amending Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act, which creates a Standards Coordinating Body within the Food and Drug Administration (FDA) to develop standards in regenerative medicine and advanced therapies. This Body will work with the Secretary of the U.S. Department of Health & Human Services to identify opportunities for the development of laboratory regulatory science research and documentary standards that would support the development, evaluation, and review of regenerative medicine products.

To establish this public-private body, the Secretary shall consult with stakeholders that will include:

  • Regenerative medicine product manufacturers and clinical trial sponsors;
  • Contract manufacturers;
  • Academia; and
  • Standard setting organizations, including the U.S. Department of Commerce’s National Institute of Standards and Technology.

The FDA must accomplish this mandate within existing budgetary availability.

Relevant Science 

What:

  • As the bill explains, “‘regenerative medicine and advanced therapies’ includes cell therapy, gene therapy, gene-modified cell therapy, therapeutic tissue engineering products, and human cell and tissue products, and combination products using any such therapies or products.”

How:

  • Alliance for Regenerative Medicine explains, “Regenerative medicine research translates fundamental knowledge in biology, chemistry and physics into materials, devices, systems and a variety of therapeutic strategies that augment, repair, replace or regenerate organs and tissues.” These strategies are revolutionary for chronic and/or life threatening diseases, for which treatment is normally palliative.
  • Regenerative medicine alters the fundamental mechanisms of the targeted disease, operating at a cellular or genetic level. Several cell therapies have been approved in the U.S., but no gene therapies have yet been approved
Endorsements & Opposition 

Endorsement:

  • The Alliance for Regenerative Medicine, the main advocacy body for regenerative medicine, supports the bill. Executive Vice Director Michael Werner told the Regulatory Affairs Professional Society, “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.” 
Status 

The bill was introduced on January 12, 2016 and referred to the Senate Committee on Health, Education, Labor and Pensions.

Primary Author 
Emma Vail
Editor(s) 
Misha Angrist, PhD, Thomas Williams, JD, MBE & Aubrey Incorvaia, MPP
Recommended Citation 

Duke SciPol, “Advancing Standards in Regenerative Medicine Act (S 2443, 114th Congress)” available at http://scipol.duke.edu/content/advancing-standards-regenerative-medicine-act-s-2443-114th-congress (04/07/2016).