Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game?

FDA untitled letter

FDA untitled letterThe FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here.

This newest untitled letter went to RichSource Stem Cells, Inc. and its CEO Sara Oracle, a firm which markets an unusual “combo” product described this way by the FDA, “a combination of amniotic fluid and membrane, Wharton’s jelly, and placental tissue.”

In my view it’s very difficult to see how such a complex allogeneic product would not be considered a drug. Also, do all the different components come from a single donor source in each case? I kind of doubt it, and if they come from different donors that makes the product even more likely to be a drug in my view.

Plus, it seems that RichSource is marketing this RICHGEN product for many health conditions having little-to-nothing to do with the inherent nature of the constituents, invoking nonhomologous use. Thus, overall RICHGEN sure seems to me to be a drug. The FDA makes some of these points in its letter (emphasis mine):

“Based on a review of your website, it appears that no exception in 21 CFR 1271.15 applies, and the products offered by RichSource Stem Cells, Inc. are intended for nonhomologous uses. Additionally, they appear to not meet all the other criteria at 21 CFR 1271.10(a), and accordingly, would be regulated as drugs as defined in section 201(g) of the FD&C Act [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. In order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)].”

As with the other perinatal suppliers, I don’t quite understand why the FDA is sending them each an untitled letter. Such letters don’t have much in the way of teeth, so to speak. Earlier I was upbeat about the FDA sending so many of these letters (dozens now it seems), but where has it gotten us?

Are these scads of untitled letters to various unproven stem cell clinic-related firms doing any good? It’s hard to say if they are changing many corporate behaviors. Maybe in a few cases. Does an individual firm care that much if it gets an untitled letter? Also, not all of these letters have been publicly released by the FDA so if they in part are intended to raise awareness, how much has that been helpful?

Or maybe the agency agenda here is that these letters lay the foundation for robust, rapid actions once the FDA’s 3-year “grace period” of a sort ends next year?

At that point maybe the FDA is going to send dozens of warning letters to firms that haven’t “shaped up” into compliance? Or maybe the agency will even directly seek injunctions against many firms?

Perhaps the agency is thinking they can more easily take these kinds of bold steps without having to do standard, lengthy inspections of every one of these firms in advance since it already sent them the untitled letters? Technically, the FDA could take more bold steps any time it sees particularly risky non-compliance even during the grace period and even without having sent untitled letters first.

As to the grace period itself, many of us feel the FDA erred in establishing such a long period during which many forms of non-compliance can apparently flourish. Unproven stem cell clinic and supplier firms have seemed to keep on going and new firms have even popped up during the 3-year period. RAPS quoted long-time fellow stem cell clinic critic, bioethicist Leigh Turner:

“Turner added that he thinks the 36-month period “was too lengthy” and has “provided a period where many more businesses are entering the marketplace.” Corporate records for RichSource show the company was incorporated in 2018, just months after FDA released its regenerative medicines framework and announced the 36-month enforcement discretion window.”

During this window are non-compliant firms at most subject to untitled or more rarely warning letters? As long as what they are doing does not reach a certain level of risk, business as usual can proceed even though there’s an unapproved drug involved?

What does it take for the FDA to be spurred to take more robust action such as the suits against Cell Surgical Network/California Stem Cell Treatment Center (still pending) and US Stem Cell Inc (FDA prevailed and case has been appealed)?

How does the agency decide, “Okay, these 700 noncompliant firms will get no action, these other 60 firms will get untitled letters, these few get warning letters, and then these handful of firms will get sued for permanent injunction?”

What’s the logic behind the different responses? A range of perceived risk?

I hope the FDA has a long game in place. Next year when the grace period ends there are likely to be hundreds of clinics and supplier firms that are actively non-compliant. Hopefully these untitled letters will have some positive role.

9 Comments

  1. I spoke with several representatives from the FDA at this years AABB meeting. Staff said they were ‘aware that clinics operating outside of FDA regulations’ existed by the hundreds, but that they were not allowed/able(?) to actively look for them themselves. Instead there had to be reportable complaints from patients or concerned citizens, and that enough credible complaints could trigger an investigation.

    Further conversation made it sound like going after manufactures was the most cost effective and work/hour efficient way to tackle the problem. “Cut off the source” seemed to be common talking point.

  2. US Stem Cell is back into business providing the banked stem cells to the past clients but doing this through American Cell Technology, a company that appears to be owned by Sean Berman, son of Dr.Mark Berman of Cell Surgical Network. So FDA prevailed and shuts US Stem Cell down, and now right back to doing the same business at the same exact location. Totally amazing….

  3. Clients are reporting they have already received their stem cells from American Cell Technology in multiple states throughout the US. They reported that the stem cells were sent to the same clinic that originally did their fat extraction for US Stem Cell, as well as ship directly to patient’s own home!

  4. Here is the actual agreement submitted in their Quarterly Report
    https://www.sec.gov/Archives/edgar/data/1388319/000118518519001306/ex_158742.htm

    The discussion of past clients now ordering with American Cell Technology is on a Facebook private group
    https://www.facebook.com/groups/Citizens.for.stem.cells/

    These are some of the comments being made…
    “Rxxxx just let me know the clinic he had his stem cell treatment done has let him know he can now access his stem cells. I just called the clinic that my cells were transferred to, and she said our cells are now accessible. I strongly suggest you call the new clinic, American cell technology at XXXXX and find out if your cells are there and how you can get to them.
    The question now is where do we go to get the infusions. Please comment on your findings when you call. Let’s take back what is ours before someone else gets in the way.”

    “They will ship them directly to you. I will post the link to the order form. $500 a dose but that was what I was paying US Stem cell each time.”

    ” I just made an appointment with XXXX Stem Cell Center to receive three doses plus exosomes on December 10th. I’m not taking any chances. I will use as many doses as possible at a time before the government decides to take them away again. I was told three doses is the maximum they can use at a time. Jxxx is right. The cells have to be prepared before they can be used. American Cell Technology will prepare them the same way US Stem did and they have to be used within twenty-fours of being sent out. My cells will be ordered by me and I will have them sent directly to XXXXX Stem Center. Hopefully this information will help.”

    • First, how do you know Sean Berman is any relation to Mark Berman?
      Second, my guess at this point is they may be sending out non-SVF stem cells like banked bone marrow since if I understood right those are not subject to the injunction, but it’s hard to know. Do you have any insights on that?

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