September 26, 2020

The Niche

Knoepfler lab stem cell blog

Has the FDA given up on regulating stem cell clinics?

rp_FDAADF-300x252.pngWhat the heck happened to the FDA when it comes to regulating stem cell clinics?

Has it given up?

Or does it just seem that way because it moves in slow motion?

The FDA might as well have thrown in the towel because, as I like to say, the stem cell field moves in dog years. Often times 7 years’ worth of stem cell happenings take place in just one human calendar year. An example of this warp speed is the approximate doubling of the number of stem cell clinics in the US in the last year or so.

There was a time when I was perhaps naive enough that I thought that regulatory agencies legally tasked with oversight of biologics would take swift action against violators, particularly if the products or procedures in question were not proven to be safe or effective. Patients are at serious risk.

Throw in some evidence of predatory behavior and dubious public claims and lack of training at some clinics, and the FDA in the US, for example, surely would do something about it as thousands of patients get these dubious interventions. Right?

I’m no so sure anymore.

I still believe in appropriate regulation of stem cell-based medical products and interventions. The FDA has now won their recent legal case on regulating proliferated stem cell products as biological drugs and it would seem they should if anything be energized to put the stem cell clinic sphere in order.

Cue crickets chirping.

The FDA appears at least on the surface not to be doing much of anything on stem cell clinics even as the number of dubious stem cell clinics in the US has stormed past 100. One problem right up the FDA’s alley for regulation is that these places are selling and using unapproved products and devices, and in that way putting patients at serious risk. For example, as best as I can tell there has been no recent FDA action on stromal vascular fraction (SVF), a product that the FDA has, at least in the past, defined in no uncertain terms as a biological drug. Meanwhile more and more clinics sell SVF treatments and it is spiraling out of control.

What is happening as a result of this lack of action by the FDA is bad for the stem cell field and for biomedical science more generally in addition to putting patients at risk as they literally pay to be participants in unapproved, for-profit human experiments. The reputation of the stem cell field overall is also in jeopardy.

It’s a weird situation. On the one hand the FDA holds those with good intentions (e.g. biotech and academic researchers working to do clinical trials) to appropriate, relatively strict standards, but on the other hand turns an apparent blind eye to an entire unregulated industry of stem cell clinics.

Even as the number of dubious clinics rockets upward, in the past year or so the FDA has issued no warning letters in this sphere and as best as I can tell not done much of anything. If the lack of FDA action meant that the stem cell clinic sphere was becoming more responsible and safer then I’d be cheering that, but instead I think it reflects some change at the FDA that is not encouraging.

The FDA has a unique opportunity to do something to help remedy this situation and clarify the regulatory sphere related to stem cells this year as it is slated to release new guidance sometime in 2014 on amongst other things SVF and other fat stem cell products. Will they punt? Will they stand firm? At this point, it’s anybody’s guess.

Here are the pertinent sections to focus on in the page linked to above:

  • Draft Guidance for Industry: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue Based Products
  • Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception
  • Draft Guidance for Industry: Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations

The FDA tells me they are taking actual actions too in this arena, but they cannot discuss it and the action is not apparent in the public sphere…yet.

However, effectively their inaction or slow motion action has created what I have termed “default deregulation” and this will only become more entrenched as the number of dubious clinics and untrained physicians pitching “stem cell” interventions without regulatory approval continues to skyrocket.

I often talk to the clinics and as appropriate I sometimes tell them they are not following FDA regulations, etc.

I’m not sure if I can even say that anymore since the FDA seems to be in effective hibernation on stem cell clinics.

Are the clinic operators right they can pretty much do whatever they want with whatever devices and products they feel like without worrying about the FDA? I’m not sure anymore because it feels like the FDA is all talk and no action lately on stem cell clinics. Well, actually, no talk and no action.

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