Senate Bill Seeks to Create Standards Body for Regenerative Medicine
Sen. Tammy Baldwin (D-WI) introduced a bill on Tuesday to promote the development of regulatory science and standards for regenerative medicine and advanced therapies.
The 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 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 a handful of cell therapies, but has yet to approve any gene therapies, though that could soon change.
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."
For its part, FDA held a public workshop in 2014 dedicated to standards development for regenerative medicines. The agency has also worked to developed guidance documents for industry covering various aspects of developing these products, such as:
- Recommendations for Microbial Vectors used for Gene Therapy
- Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
- Preclinical Assessment of Investigational Cellular and Gene Therapy Products
- Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products
- Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products