I recently asked Celltex if they had definitely convinced the FDA their product was not a drug (i.e. the FDA confirmed their product was not a drug) or rather they had tried and hoped they had. It appears the latter is correct from the Celltex response below:
Dear Dr. Knoepfler,
Thank you for your interest in Celltex. In your latest inquiry, you sent two interrelated questions, both asking for FDA’s thinking. We cannot speak on behalf of the FDA. We maintain an open, positive dialog with FDA. FDA’s oversight of our operations will continue as we are providing HCT/P services. For example, we anticipate, and welcome, a return visit from the FDA before the end of this year, consistent with the agency’s typical practice for following up on a 483. We are operating as an HCT/P facility and FDA is fully aware of that fact. Sincerely,
The Celltex Team
Based on talking to many experts in the field, I disagree with Celltex. In my opinion the FDA will remain steadfast that Celltex is in fact operating a drug manufacturing facility (as was how the FDA described Celltex on the 483 report), not an HCT/P facility. I could be wrong of course.
Interestingly, the answer above also reveals that Celltex is expecting a 2nd visit from the FDA relatively soon.
Kudos again to Celltex for engaging in this dialogue with me.
If nothing more, it is great to see CellTex rise to the occasion and be very open and transparent with you and your readers during a very important time in their genesis. I congratulate Mr. Eller and his staff.
Hi Dr. Knoepfler, just a thought about the category of drug manufacturer on the 483. Put yourself in the place of the investigator trying to determine what is what at the CellTex site (that is the objective). Wouldn’t you rather begin from the drug manufacturer position and let CellTex make their case for HCT/P rather than vice versa?
I see your point, Mario, and there’s some logic there. However, I’m not sure that’s how the FDA works based on what I hear. They take great care in what they call a company from the beginning because it has a lot of importance. The term used to describe a company on that first 483 form is really a defining moment.
I personally believe that definition will not change for Celltex barring some radical change in their stem cell product (i.e. it is no longer expanded) or some new court ruling years down the road, but as I’ve said that’s just my opinion and I could be wrong.