The FDA’s biologics or CBER branch just warned two perinatal biologics firms. In a way, these letters surprised me more than any in recent years.
Up to this point, I had not seen any posted warning letters from the Trump 2.0 FDA to stem cell clinic or biologics supplier-type firms. Part of me thought that flatlining of actions might continue throughout much of this year.
So are these two new letters encouraging as signs of CBER taking timely, appropriate action on unapproved perinatal biological drugs? Might CBER continue to function well despite RFK Jr.’s apparent interest in lowering oversight of birth-related “adult stem cells”? And even with the ouster of Peter Marks?
Let’s dig into what these letters say and may mean, especially in the context of a dozen or more biologics warning letters last year.
Warnings to perinatal biologics firms
Supreme Rejuvenation
The first new FDA warning letter I saw went to CEO Aracely Cabrera or Supreme Rejuvenation. It says, “…you sell “100 Billion Exosomes: Human Umbilical Cord Mesenchymal Stem Cell Derived Exosomes,” “15 ml 100 Billion Exosomes: Stem Cell Exosome Gel,” and “30 ml 200 Billion Exosomes: Stem Cell Exosome Gel” for allogeneic use.” As the letter notes and the FDA has said before, generally exosomes are defined drugs requiring pre-market approval. In other words, you need to work with the FDA before marketing exosomes, but many firms do not.
One of the things I like about this letter (we’ll see over time if my opinion changes) is that it doesn’t mention any inspection. Does it seem paradoxical that I saw that favorably?
I’ve advocated in the past for CBER to issue warning letters to regenerative clinic firms without necessarily doing any in-person inspection if online or other marketing clearly indicates the product in question is an unapproved drug.
Why is this important?
The in-person FDA inspection is a major rate-limiting step in the oversight process. If the FDA doesn’t always require itself to do the inspections, it can issue much larger numbers of letters and so respond more nimbly to problematic marketing of what it sees as unapproved biological drugs. I also believe the agency should be issuing potentially many fines to serious offenders in this space, but we haven’t seen that and probably won’t anytime soon.
Trying to learn more about Supreme Rejuvenation on the web, I found its website and social media accounts no longer appear active. It seems to fit broadly into the category of perinatal exosome suppliers making all kinds of health claims.
Skye Biologics
The second letter went to CEO Christopher M.B. Sharp of Skye Biologics.
Here the FDA says it did an inspection and “documented that your company manufactures “placental connective tissue matrix allograft” products derived from umbilical cord, namely BioECM™ (collectively, “your products…This letter is to advise you that your products are unapproved new drugs.”
The agency also added toward the end, “we have concerns with your “placental connective tissue matrix allograft” products derived from umbilical cord, namely BioRenew™, and products derived from amniotic and chorionic membrane and umbilical cord, namely HRT® BioPower-A, HRT® BioPower-C, and HRT® NX”. The FDA is asking whether the firm thinks these are 361 (non-drug) products and why.
One odd thing about this letter from November of last year is that it cites inspections in 2022. What’s been going on in the interim?
Predicting how the Trump 2.0 FDA and CBER will oversee biologics
Frankly, I’m not sure yet what to think of these first two warnings of the second Trump administration.
Much will depend on how CBER conducts oversight moving forward.
Over the last four months has CBER’s oversight of the regenerative and biologics sphere continued much the same as before or mostly gone dormant? If the latter, we probably won’t see many more warnings in coming months.
We don’t yet have enough information to predict how new CBER Director Vinayak Kashyap Prasad (Vinay Prasad) might change CBER’s approach cell therapies. So far the priorities of FDA Commissioner Marty Makary on biologics are also unclear.
For the moment, I take these two new warning letters as a potentially mildly encouraging sign. Perhaps cinical trial data and standards will still matter in cell therapy oversight. Also, maybe just because some products are perinatal in nature won’t mean they are largely exempt from regulatory scrutiny and action.
When I was first diagnosed with ALS, we traveled from Central Pennsylvania to Phoenix for Stem cell therapy four times over the course of a year. We discontinued treatment as it became cost prohibitive and too disruptive to everyday life. They used a drug to open the blood brain barrier, administered the cells then finished with a high dose of B12. What process do you use?
Thanks, Paul. I want the FDA to regulate cell products, so I appreciate a bit of good news.