I believe the agency is taking on major risk overall by clearing a vast number of cell therapy trials for COVID-19 mostly without much data, but the clearance of a few programs by for-profit stem cell clinics is especially problematic in my view. FDA on the ball more generally on clinics
For background and on the positive, the FDA is taking the problem of the stem cell clinic industry very seriously and taking action on clinic firms that are injecting patients with unapproved stem cell drugs.
It has sent off dozens of untitled and warning letters to clinic firms pitching unproven stem cells and other regenerative biologics like exosomes. The agency’s biologics branch called CBER is really on the ball on this these days. Its Director Peter Marks deserves big kudos for the serious commitment and marathon work here over many years to make things happen on this problem. Dr. Marks was the subject of an interesting piece in the WaPo by Laurie McGinley recently: Meet the most important federal official you probably don’t know — the man who holds the fate of the coronavirus vaccine in his hands.
Politics & FDA clearance of 2 stem cell clinic COVID-19 efforts
ReplyDeleteFDA is doing better job on unproven stem cell clinics, but it has cleared many INDs, some iffy, for stem cell and cellular medicine trials for COVID-19.
The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern.
I believe the agency is taking on major risk overall by clearing a vast number of cell therapy trials for COVID-19 mostly without much data, but the clearance of a few programs by for-profit stem cell clinics is especially problematic in my view.
FDA on the ball more generally on clinics
For background and on the positive, the FDA is taking the problem of the stem cell clinic industry very seriously and taking action on clinic firms that are injecting patients with unapproved stem cell drugs.
It has sent off dozens of untitled and warning letters to clinic firms pitching unproven stem cells and other regenerative biologics like exosomes. The agency’s biologics branch called CBER is really on the ball on this these days. Its Director Peter Marks deserves big kudos for the serious commitment and marathon work here over many years to make things happen on this problem. Dr. Marks was the subject of an interesting piece in the WaPo by Laurie McGinley recently: Meet the most important federal official you probably don’t know — the man who holds the fate of the coronavirus vaccine in his hands.