October 21, 2020

The Niche

Knoepfler lab stem cell blog

More tough FDA draft guidance on stem cells…still no action

FDA logoThe FDA released more draft guidance with strong relevance to the stem cell field.

This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular fraction (SVF; fat stem cells) was much more restrictive than generally thought in the for-profit stem cell clinic field.

“Industry” apparently hasn’t been happy about this.

For instance, December 2014 FDA draft guidance very clearly indicated that fat-related stem cell products like SVF are more than minimally manipulated and hence are drugs requiring pre-approval and licensing. Another draft guidance on the same day surgical exemption issued a few months earlier also seemed (appropriately) to point toward more stem cell products being drugs requiring pre-marketing approval.

Still, to my knowledge the FDA has not actually finalized these guidances or taken any action based on them.

The new 2015 draft guidance aims to provide clarity and answer questions on the issue of homologous use. My sense is that this draft guidance, if ever finalized, would limit the unapproved uses of specific human tissues including amnion.

One particularly telling phrase from the new guidance stood out to me:

Generally, if an HCT/P is intended for use as an unproven treatment for a myriad of diseases or conditions, the HCT/P is likely not intended for homologous use only.

This sure sounds like how hundreds of stem cell clinics are using unapproved adipose and amniotic “stem cells”. Thousands of patients are spending millions of dollars right now on interventions violating multiple FDA perspectives mentioned in the various draft guidances.

Yet despite all this “tough talk” in draft guidances, by all accounts the FDA seems to be doing nothing to back it up in the way of actual actions on stem cell clinics violating these proposed rules or via finalized guidances. For instance, the CBER branch of the FDA suddenly stopped taking actions on stem cell clinics almost 2 years ago and since has done little if anything.  In the same period of time the number of stem cell clinics has roughly doubled. That is an equation for trouble and risks to patients.

What gives with the FDA?

In part I think they are just unbelievably slow in how they take steps on things, but that glacial slowness isn’t working to protect patients in the context of the warp-speed stem cell clinic world. They may also be getting political pushback on what seems to be emerging as a firming up path to regulating adipose stem cell products as drugs.

A big HT to Alexey Bersenev for pointing out the new draft guidance (see #5 in his post and another post). I recommend reading his post for another valuable view on this. He also points out that stocks have dropped for some companies related to this draft guidance and the FDA will hold a public hearing next year on these new draft guidances.

At this snail-like pace from the FDA we can expect these guidances might be finalized (assuming they ever are) in some revised form in…about 2-3 more years. By then there will probably be more than 1,000 stem cell clinics in the US selling unapproved stem cell drugs…

I’m all for public engagement by the FDA and responsiveness to feedback, but the FDA doesn’t have time to move so slowly.

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