Biologics

GAO Regenerative Medicine Policy Options

The Government Accountability Office (GAO) says its study of regenerative medicine led to the development of 11 policy options, several of which involve FDA. GAO says it conducted an assessment of current and emerging regenerative medicine technologies and therapeutic applications. The report looks at (1) current and emerging regenerative medicine technologies and therapies and their potential benefits; (2) challenges that hinder their development and use; and (3) policy options that could help enhance benefits and mitigate challenges associated with the technologies and therapies.

Challenges that may affect the development and use of regenerative medicines technologies and therapies include standardization, regulation, and manufacturing, GAO says.

The report says the policy options “are provided to inform policymakers of potential actions to address the policy changes identified in the GAO technology assessment….Policymakers would need to consider the impacts these new technologies will have on existing federal programs that are already strained.

Four key policy options highlighted by GAO are:

invest in standards development;
provide opportunities for increased interactions between regulatory experts (at FDA or in industry) and smaller companies, especially early in the development process;
consider whether changes to the framework for evaluating combination products and medical devices to accommodate emerging technologies and therapies may be necessary; and
provide more oversight and feedback to suppliers to increase consistency in starting materials.

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