FDA Commissioner Scott Gottlieb, M.D. said in the December 20 announcement that FDA is still “committed to advancing the field of cell-based regenerative medicine,” but “At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk.”
“The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion. We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients,” Gottlieb said.
The November 2017 FDA “Framework for the Regulation of Regenerative Medicine Products” includes two guidance documents. The main document, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use Guidance for Industry and Food and Drug Administration Staff” covers human tissue from a donor, or human tissue extracted from a patient and later reintroduced into the same patient in a subsequent surgical procedure.
The second document, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception Guidance for Industry” is brief guidance setting the conditions under which autologous use—that is, taking tissue from the patient and reintroducing it in the same procedure—is permitted.
In an interview, Schwartz said, “It is unclear whether the products that Liveyon is referencing on their website are the same ones that Genetech received its Warning Letter for. That said, it is likely that FDA would argue that any umbilical cord stem cells used for these indications violate at least two of the four criteria for regulation solely as a 361 HCT/P (i.e., that they are intended for a non-homologous use and that they are dependent on the metabolic activity of living cells for their primary function), thereby rendering the product an unapproved drug and biological product.”
The State of the Science (and the Profiteering) of Living Cell Implants
The state of the science in the use of stems cells in orthopedics is covered in depth in two recent Orthopedics This Week articles, “Mixed Cells, Not Stem Cells,” Tuesday, November 6, 2018, and “The Wild West of “Stem Cells: Updated,” Thursday, October 11, 2018.
We’ll have more on the prices and profits in: Upcoming in Part 2: Liveyon Markets On
