One of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog.
- What does a warning letter really mean? What triggers it?
- Why do some businesses selling stem cells get inspected and others don’t?
- What do some entities get warning letters over the years, while others don’t?
- What weight does a draft guideline have?
- How about a finalized one?
- If a business disagrees with an FDA guideline or action, what should it do?
- If a business operates without FDA approval (maybe because they disagree with the FDA) when it seems that it should need that approval and yet the FDA takes no action, does that mean anything?
The list goes on and on.
It’s kind of like trying to read tealeaves. One of the FDA reforms I advocated for in my book, Stem Cells: An Insider’s Guide, is more clarity and better communication.
Despite the many questions and confusion out there, I would say one thing is clear: Take FDA “current thinking” very seriously.
While current thinking as articulated in guidances (draft or otherwise) is not formally equivalent to a regulation, it would seem to have the power to trigger action based on the historical record.
Therefore, one broader lesson in this arena would seem to be that the FDA can pull the trigger on actions like visits and warning letters based on their current thinking even if that current thinking is not formally crystalized beyond draft guidances or even without any draft guidances. For instance, it seems pretty clear that the FDA right now views SVF as a drug and while it may not have done much about this action wise yet, the odds are that such action will be coming sooner or later. The same goes for non-homologous use of bone marrow and amniotic stem cells such as for neurologic conditions. In other words, what the FDA staff think is going to be their basis for actions.
As a result, it kind of goes both ways in the sense that guidances (draft or otherwise) are not formal regulations and “only” reflect current FDA thinking, but at the same time “FDA current thinking” shouldn’t be underestimated in terms of importance as it clearly can play a big role as the basis for action.
Too often I’ve heard clinics or other advocates say things like, “these are just draft guidelines” or “the FDA hasn’t been clear on that yet”. The reality is that no matter what any of us might like (e.g. increased FDA clarity), it is not the FDA’s responsibility to make sure everything is crystal clear for every stem cell clinic out there. Rather, it is the physicians’ responsibility to do their homework on the FDA and all relevant regulations, current thinking, etc.
If a clinic wants to challenge the FDA I can respect that if it is done responsibly, but it is a very different matter and a risky game to do such a challenge operationally by administering what by all accounts the FDA considers to be unapproved drugs into patients and then waiting to see if anything happens on the regulatory front.
This game of stem cell chicken is particularly risky if you are “treating” medical conditions outside of your specialty and do not have any rigorous training in stem cells as well as having little if any expertise in FDA regulatory affairs. And, no, a weekend resort or other similar quickie “course” on stem cells doesn’t really count.