Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics.
The Panama clinic sells unproven umbilical cord cells grown in a lab for a host of medical conditions. I’ve had many concerns about it over the years, particularly their unproven autism “treatments.”
In the U.S. such a product is generally considered a drug and requires FDA approval based on rigorous clinical trials.
So what does Signature Biologics, located in Texas, sell? How does it fit into the scope of FDA oversight?
FDA warning to Neil Riordan: your product is a drug
The FDA just issued Signature Biologics a warning letter. The warning focuses on the firm’s umbilical cord product Signature Cord.
As with many perinatal cell therapy producers who get warnings, this letter to Neil Riordan starts by saying they need and don’t have FDA approval:
“Therefore, your product is a drug.” And the agency adds:
“Your product is not the subject of an approved biologics license application (BLA), nor is there an IND in effect for your product. Based on this information, your actions have violated the FD&C Act and the PHS Act.”
In other words, the FDA says this is an unapproved drug.
FDA letter notes many Signature Biologics CGMP deviations
The warning follows the pattern of other such letters in the birth-related stem cell drug manufacturing and clinic arena as it goes on to list many CGMP issues. The first on the list is, “Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.” This is a big deal as no one wants to get a cell therapy product that runs the risk of contamination.
The second CGMP bullet point in the letter builds on this concern, “Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area.”
The letter goes on to note seven major categories of CGMP concerns.
Signature Biologics has reportedly responded, as noted in the warning, but the FDA says the responses have not been adequate. The agency does note, “your commitment to voluntarily suspend the manufacture and distribution of Signature Cord.”
So is this product no longer being used on people by firms that bought it from Signature Biologics? From the agency letter (emphasis mine):
“FDA received your written responses dated January 10, 2022, March 1, 2022, April 1, 2022, May 24, 2022, June 30, 2022, August 31, 2022, and November 2, 2022, to the inspectional observations on the Form FDA-483. The corrective actions described in your responses are not adequate to address the above-referenced deficiencies. We note that certain corrective actions cannot be evaluated because they lack supporting documentation. In addition, your responses do not address your specific plans for disposition of the inventory of Signature Cord™ at your facility.“
It’s also striking how the firm wrote to the FDA seven times.
Placental Signature Biologics products too
I turned to YouTube to see if I could learn more than the firm’s website.
Something called the Fraum Center For Restorative Health has a YouTube video all about Signature Biologics. See below. The video is well-made, but it raises quite a few questions. Update: Within days of this post, Fraum Center took down the video about Signature Biologics. I wonder why?
To me it seems like the video implies the products in question are not drugs. Note also that the video mentions placental products, whereas the FDA letter notes umbilical cord material.
How many other firms besides the Fraum Center use Signature Biologics products?
Could the firm’s placental products also be drugs? Are they also widely used already?
Office of Biological Products Operations – Division 2
The warning letter is signed by Karlton T. Watson, Program Division Director of something called the “Office of Biological Products Operations – Division 2.” It’s been interesting to see that the FDA’s CBER branch, which is in charge of biologics, has issued fewer direct warnings itself lately.
Instead, we’ve seen more from the Office of Biological Products Operations, either Division 1 or 2, but especially 2.
I’ve written before about this relatively new FDA division including in regards to a warning last year to another firm. As I wondered then, does the Office of Biological Products Operations – Division 2 have enough staff and resources to effectively oversee the unproven cell therapy arena in the U.S.? I’d say the jury’s still out on that overall.
However, as I’ve also noted before, the unapproved perinatal drug space is one biologics area where the FDA has devoted relatively more resources and taken more action. Perhaps this emphasis is because of infection risks that can come along with these products due to their sourcing. The Liveyon mass infection event via umbilical cord material that sickened dozens of people probably also comes into play.
What’s next?
Even if Division 2 is not satisfied with future responses from Signature Biologics, sadly I’m not sure they’ll do much more about it any time soon.
As we’ve seen with other warned firms such as Invitrx Therapeutics, also a recipient of a Division 2 warning, the FDA might follow up just with more warnings over a period of years and no concrete action.
This is way too slow for oversight of a dynamic overall space like the unproven perinatal cell industry.
Hopefully, Signature Biologics will promptly resolve the issues outlined in the letter so no further FDA action is needed at all there.
For more background, see this explainer post: What is an FDA warning letter & how should firms respond?