The REGROW Act has attracted both support and criticism, including on this blog, for the changes it would mandate in the way the FDA regulates stem cell products. More specifically it would greatly reduce regulation of experimental stem cell products. I believe that would be dangerous to patients and to the stem cell field more generally.
One additional important issue about REGROW that oddly hasn’t been talked about very much is that it would only apply to adult stem cells. So if the fans of REGROW had their way, the U.S. would end up with a regulatory system that gives adult stem cells a relative free pass.
— Mark Kirk (@SenatorKirk) May 2, 2016
Why was REGROW written like this?
I wonder if in part (see yesterday’s tweet above from Senator Mark Kirk, the prime driver of REGROW that cites both the Act and the Pope) it is based on religious beliefs? I tweeted back to Senator Kirk asking why the bill doesn’t include embryonic stem cells and IPSC. We’ll see if he responds.
More practically speaking, probably REGROW’s creators felt it would have a better chance of passing and garnering support from fellow Republicans (and yes, I know it has some Democratic support too) if it was only on adult stem cells. But I believe that some of those pushing REGROW likely themselves are opposed to embryonic stem cell research.
Some will certainly argue that pluripotent stem cell therapies are going to be riskier so that is why they were excluded, but I’m not convinced that makes solid sense if we are talking about stem cell products already having INDs and successfully passed through Phase I/II.
Interestingly, in Japan the regulatory changes so often cited by REGROW as a model to follow and also by the Bipartisan Policy Center report backers as such a great thing, do include embryonic stem cells and IPS cells in the new regulatory framework. Some cherry picking then with REGROW?