The International Cellular Medicine Society (ICMS) is viewed somewhat skeptically by the stem cell community, but they are undeniably an important player in the stem cell world.
A few weeks ago I interviewed ICMS President, Dr. Ricardo Rodriguez (see interview here), and then I provided recommendations here to the ICMS to improve their organization including a less adversarial relationship with the FDA amongst other recommendations that include a patient resources webpage and an outside advisory committee.
ICMS more recently announced in a PR that its IRB has been audited by the FDA.
Now ICMS has gone a step further in an encouraging sign of transparency and publicly posted the FDA report (called a 483) from the audit. You can read it here (PDF). The audit took place over 4 days according to the 483.
It’s fascinating reading. ICMS also posted a PR on the audit.
The FDA made 8 observations about ICMS and most of the observations were broken down into subsections as well. These observations, to paraphrase the FDA website, are basically things the FDA views as “objectionable”.
What are the FDA concerns?
There are quite a few, but generally the concerns point toward the FDA wanting ICMS to more strictly govern how it runs its IRB. I am not a regulatory expert but it seems to me that “Observation 1” may be the most significant (see below). I’d value other input from the blog readers on the 8 observations.
In the ICMS PR about the audit they make a number of statements about the FDA and the practices of the ICMS. Executive Director, David Audley is quoted as follows in the ICMS PR:
“While we have not yet received the final report from the FDA, we are very pleased with their initial conclusions.” stated Audley. “The FDA’s comments were limited to relatively minor issues such as increasing the level of detail in meeting minutes and providing a clearer explanation of the relationship of reviewers to the ICMS. We expect to be fully compliant with the recommendations of the FDA by August 1, 2012.”
At this time there is still no news from the FDA regarding its reported visit to Texas stem cell firm, Celltex, and Celltex itself is mum, but I’m thinking we should hear something about that pretty soon. Grapevine on this remains mixed as to the outcome….stay tuned!
I speculate:
Celltex will be in compliance with cGMP rules.
What may be more concerning will be the IRB oversight of “practice of medicine exempt from FDA.” This is the realm of physicians operating under the new TMB rules. Now the stakes go up. If the FDA has a problem with this (and I suspect so), we will probably see the State of Texas take this to court and we will be in a huge legal battle that will shut down the new approach for a long time.
Mario, you are probably very insightful based on what I’m hearing. The coming week is going to be a big one I think in terms of us learning a great deal about this for various reasons and we’ll if you are right!
The FDA rules state that a 483 is completed after the site visit. To my knowledge the visit was over this week or last. In fact the FDA may have even seen patient treatment or patient records. Remember 100 or patients have been treated already.
Unless certain issues extended the investigation I think we hear something soon.
Eller is a smart man and Cell Tex is very well funded and connected. I presume both parties are being overly cautious. Sorta like 2 prize fighters coming into the center of the boxing ring and just circling each other waiting for the fight to start.
I don’t think we will see the 483 put on the Cell Tex web site as David Audley did wih ICMS.
To me the Cell Tex issue will be huge, either way, don’t you agree Dr. Paul?
It appears the system has inspected ICMS, and the infractions listed on the departure 483 appear to bookkeeping in nature and correctable.
I applaud Mr. Audley & his open transparent release of the report for all to see.. This is how it’s supposed to work kids!!!!
Let’s all get on with good science!!!
And if more inspections are warranted I’m sure the FDA will knock on ICMS’s door and be invited back in.
Any thoughts on the Celltex FDA audit?