January 16, 2021

The Niche

Trusted stem cell blog & resources

REGROW Act is Attack on Science-Based Stem Cell Trial Oversight

REGROW ActSenators Mark Kirk, Joe Manchin, and Susan Collins have proposed new legislation in the form of the REGROW Act that would substantially interfere with the FDA’s ability to properly regulate the development of new stem cell and regenerative medicine therapies based on hard science.

The REGROW Act would force the FDA to allow rushed introduction of experimental stem cell interventions into patients even if the science did not support that these were safe or effective at that time.

From the Kirk press release:

“Unfortunately the Food and Drug Administration (FDA) has identified the current lack of regulatory standards in this area of medicine as an impediment to treatment development. Countries like Japan and England are outpacing the U.S. in regenerative medicine therapy development due to new regulatory policies that the U.S. has yet to mirror.

S. 2689 will allow the United States to regain prominence in the field of regenerative medicine science and bring therapies quickly to the patients that need it most.”

This libertarian agenda fits with the recent BPC report that overreaches on FDA deregulation. See my take on the BPC report here.

You can also see a nationalistic agenda evident in the language that is not scientific. Just because some authorities in Japan have chosen to dramatically weaken regulation of stem cell therapies there and made other questionable decisions such as more widely allowing charging of patients to be in stem cell clinical trials, doesn’t mean the U.S. should follow the same somewhat reckless path.

These practices are highly questionable from a bioethics perspective and also from a simple common sense view that rushing ahead too fast can actually slow things down by leading to catastrophic patient outcomes. The Jesse Gelsinger case with gene therapy comes to mind and its interesting that some advocate a race car mentality for use of CRISPR in humans too.

My understanding is that the dubious stem cell clinic lobbying force is happy with the REGROW bill as it would shift the regulatory framework toward their philosophy even if they don’t get everything they want. REGROW proponents want to rocket forward with stem cells into patients by eliminating Phase III trials and establishing a risky conditional approval paradigm. I haven’t seen any evidence that Phase III clinical trials for stem cells are unnecessary nor that the conditional approval paradigm would be safe.

The REGROW Act summary page is here and the full text of the bill is here. Fortunately analysts predict only a 4% chance of passage of this dangerous bill.

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