Monday, January 15, 2018
Stem Cells! The New England Journal of Medicine published an article on regenerative medicine. Rejuvenating Regenerative Medicine Regulation explains FDA action regarding the regulation of regenerative medicine.
The Food and Drug Administration (FDA) recently made long-awaited progress toward protecting patients from interventions involving human cell- and tissue-based products (HCT/P) of unknown safety and efficacy. By clarifying its position on the handling and therapeutic use of cells, the agency has sent a clear signal that it intends to regulate a broad swath of highly manipulated cellular materials as biologic drugs. This is a welcome development, and complementary action taken at the state level and by professional societies would further promote the interests of patients.
The question of whether using the patient's own stem cells falls under the FDA or medical practice has been one of debate, which are addressed with the issuance of these guidance documents. The authors see these as a step in the right direction but not the final step. A pdf of the article is available here.