Regenerative Medicine Promotion Act
The Regenerative Medicine Promotion Act of 2014 (H.R. 4494; S. 2126) launches a national initiative on Regenerative Medicine. It supports this technology through development of a federal framework, increased funding for research and commercial development of products, and development of a regulatory environment that enables rapid approval of safe and effective products. Specifically, the Act would do the following:
- Require our port from the US Government Accountability Office that details on going Federal activities in regenerative medicine.
- Establish the Regenerative Medicine Coordinating Council.
- Establishes a public-private Council to devise a national strategy for the promotion of research into regenerative medicine and the development of drugs, biological products, medical devices, and biomaterials; identify and recommend policies to overcome barriers in research and product development; and specify priorities for research into regenerative medicine and the awarding of grants under the Act, among other things.
- Requires the Council to issue an annual report on the state of regenerative medicine.
House Version of the Act Only:
- NIH Grants for Academic-Industry Collaboration creates two translational research grant programs at NIH to nurture academic-industry collaboration in regenerative medicine.
- Funds for non-profits or institutions of higher education to conduct basic or preclinical research into regenerative medicine, if the research is partly funded by a private company.
- Grants to collaborative partnerships, which include a nonprofit/institution of higher education and a private company, for R&D of regenerative medicine and the making of an investigational new drug (IND)/investigational device exemption (IDE) application at FDA within 4-years.
- NIH Grants for Private Companies - to support product development in regenerative medicine through the existing Cures Acceleration Network. Grants will support basic research, pre-clinical studies, and clinical trials for pre- and IND/IDE applications in regenerative medicine.
- FDA Grants for Regulatory Research - to foster development of a clear, predictable regulatory pathway to enable speedy approval of safe and effective products, the Act authorizes FDA to conduct regulatory research to help in the approval of regenerative medicine products. Research would be public-private partnerships.
The Act does not authorize any new funding.
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