The REGROW Act is a bill that seeks to lessen the regulatory burden to accelerate getting stem cells to patients more quickly, but it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole. The REGROW Act, which is sponsored by Senator Mark Kirk of Illinois, has had several incarnations, but the latest new one reflects some big changes so I’m going to call it REGROW 2.0. A source provided me with a …Read More
Today an opinion piece that I wrote about CIRM was published in the San Francisco Chronicle. The unusual element here is that the article is critical of CIRM. More specifically I raised concerns about a recent political trend at CIRM under its new President Randy Mills lobbying for dramatically weaker stem cell regulatory oversight. The Chronicle piece was first posted online on Thursday on the paper’s website. I encourage you to read it when you get a chance. For a decade I have been one of the most consistent …Read More
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.
The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved. Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for that, especially from stem cell clinics. For instance, I am publicly opposed to the REGROW Act, a piece of legislation that would dangerously weaken oversight of experimental stem cell therapies. …Read More
We’ve heard of payphones, pay toilets, and other services for which people have to pay for access, but what about pay clinical trials? In a pay clinical trial, patients have to pay anywhere from $10K to over $100K to get in the door. I asked readers of this blog about how they feel about patients having to pay those running clinical trials just to get into the trials of experimental therapies. In that poll, 70% of the more than 120 responses felt negatively about …Read More