What were the top posts here on The Niche for the past year? I’ve listed some of them below along with some posts from 2015 that remain highly read. Some top 2016 posts 20 Nominees for Stem Cell Person of the Year 2016 Award REGROW Act is Attack on Science-Based Stem Cell Trial Oversight Will new gene editing tech NgAgo challenge CRISPR? FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US Public stem cell skirmish erupts between Hanna & Jaenisch Controversy over …Read More
The 21st Century Cures Act has some important provisions that would impact the stem cell and regenerative medicine field. What is driving these efforts is a widespread sense that the status quo of regenerative medicine oversight isn’t working very well. I’m talking with key stakeholders and still trying to sort out my thoughts on the stem cell provisions in Cures. What would it mean? Cures’ language on stem cells is nuanced and its provisions also are not so black and white as REGROW was in …Read More
Will Trump trump the FDA? Our President-elect recently released his health care policy agenda and it looks like the FDA is a target in terms of reducing oversight. Over at the Washington Post, Carolyn Johnson has a nice article on this development. One point in the agenda in particular has caught people’s attention as potentially the key indicator of what is to come for regulatory oversight of biomedical products: “Reform the Food and Drug Administration, to put greater focus on the need of patients for new …Read More
One of the biggest stem cell news stories of 2016 has been the REGROW Act, a bill intended to accelerate investigational stem cell and regenerative medicine therapies to patients by lessening FDA oversight, but in the last couple months REGROW has mostly disappeared from the news. Will REGROW do a reappearing act like some kind of magician? REGROW is in fact still out there so it is not gone by any means. Republican senators have been discussing including REGROW in a large medical spending bill …Read More
Today was the first part of the FDA’s 2-day meeting on stem cell draft guidances. It was a great meeting I thought. A few consistent themes and notable things emerged as raised by participants.
The FDA is holding its first 2016 stem cell meeting today. How’s the meeting going? The meeting start awfully early for us West Coast folks (5:30am) so I didn’t get to see the first few talks. Did anyone else see those and if so, what was your impression? From the talks I have seen, this meeting is very scientifically focused so far. There has been a lot of clinical trial data presented, which for me as a scientist I really appreciate. We’ve heard about promise, …Read More
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.