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Senators 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.
Just because some authorities in Japan and England 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.
Read full, original post: REGROW Act is Attack on Science-Based Stem Cell Trial Oversight
