Perinatal biologics supplier Platinum Biologics recently received an FDA warning letter.
A second perinatal biologics firm, Innate Healthcare Institute, was also recently warned. I’m primarily going to focus on the warning to Platinum Biologics, but both letters have a paradoxical element to them.
Why?
These warnings provide some hope of normalcy in FDA biologics oversight moving forward.
Let’s take a look at the letters, starting first with the one to Platinum. Beeben Russell is its leader.
Platinum Biologics FDA warning letter
The letter notes several products that the agency mentions as having related violations including as unapproved drugs:
“…two umbilical cord derived products, Nano PRP Jelly and Nano Flex, and two exosome products, NanoEx and Nano Xsomes, for allogeneic use (collectively, “your products”).1 This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of section 351″
The FDA has consistently defined both umbilical cord products and exosomes more broadly as being drugs requiring premarket approval. No firms have such approvals except for related to umbilical cord cells used in a similar fashion to bone marrow transplantation or hematopoietic stem cell products for use in limited ways such as for immune system reconstitution after chemo. You can see my full list of FDA-approved cell and gene therapies.
The warning letter notes that the Platinum Biologics products don’t meet minimal manipulation or homologous use standards for non-biological drugs (361s).
Other biologics folks weigh in on Platinum Biologics
Chris Centeno over at the Regenexx Blog did a 2024 post about Beeben Russell and Platinum Biologics that’s worth a read.
Centeno notes that Beeban Russel was “former VP of sales for Regenative Labs.”
Why is this important? Regenative Labs itself previously got an FDA warning too.
It’s also worth looking at a post and discussion on LinkedIn started by Don Buford about the Platinum warning letter. From Don’s post:
“The FDA is letting Beeben Russell and Platinum Biologics know that their products are not compliant and that what they have been telling people for years is frankly untrue. In other words, the FDA has just put Platinum Biologics on notice for marketing and selling products that are drugs without getting FDA approval. All of the doctors, chiropractors and clinics that bought these products and injected them in people now have additional significant legal risk for injecting patients with an unproven and unapproved drug. Anyone with a bad outcome or even just with NO outcome who was misled is likely to sue for damages or to get their money back.”
Innate Healthcare Institute warning
The other warning letter, to Innate Healthcare Institute, went to its leader, Travis Whitney, NMD. The letter noted that the firm,
“markets umbilical cord mesenchymal stem cells (UC-MSCs),” which you also describe as “UC-MSC therapy” (hereinafter, “your product”) for allogeneic use. This letter is to advise you that your misbranding of your product while held for sale after shipment in interstate commerce violates section 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(k).”
Some of the marketing is concerning, including the statements about autism. The FDA also mentioned misbranding of the UC-MSCs.
In addition, the FDA letter noted potentially problematic exosome marketing in this letter.
These letters could also be a hopeful signal regarding the FDA
So what are these letters now from Makary’s FDA telling us?
One of the first things that struck me about the Platinum Biologics letter was that the agency didn’t mention any inspection of the firm. Same for the letter to Innate Healthcare Institute. In a way, that’s a good thing. The FDA should not be requiring itself to inspect every firm if the potential deviations relate to marketing that is readily apparent, such as on the web.
Requiring in-person FDA visits to firms is a major roadblock to more efficient agency action.
The inspections aren’t always needed and sometimes it seemed in the past that the FDA was requiring itself to do inspections when they may not be needed.
Through the latter part of the first Trump administration and throughout the Biden administration, the FDA prioritized oversight actions on perinatal firms. These new letters appear to continue that trend, which provides some reassuring consistency. Since RFK Jr. seems a fan of perinatal stem cells, there has been some uncertainty about what the FDA might do or not do about firms selling them without agency approval.
State laws conflicting with the FDA
It’s also significant that Platinum Biologics is located in Florida. As many of you may know, there’s a new Florida stem cell law saying FDA approval isn’t needed for use of certain cell injections.
Many in the field have been wondering if the FDA would confront the Florida stem cell law (and other similar state stem cell laws) since federal law preempts state law, or could the agency turn a blind eye?
The new FDA warning letter to Platinum could be a positive sign that the agency will tackle stem cell providers who market stem cell drugs based on state laws without FDA approval.
It’s going to be important to watch what the FDA does as more firms seek to take advantage of permissive, risky state laws.
Inspections for what?
This FDA letter is not on the efficacy of the product, it’s about providers, that use Platinum products, claiming the exosomes will heal, treat, prevent disease.. which since they’re not FDA Approved “drugs” cannot say.
If a manufacturer give products to outside providers to use as they see medically fit based on research, how do they ensure those outside providers stay compliant?
If those providers then choose to lack this integrity, the buck gets passed on.
Actually, manufacturers have some responsibility for how their medical products, especially things that are drugs, are used by their clients. Further, when something per the FDA is an unapproved drug, then a manufacturer should be selling it to no one who might use it clinically. Are you suggesting that one of the firms that got a letter here only was selling its product for research-use only?
@admin- Do you agree that Federal law should supersede state law?
@Bill, that’s what the law says. It generally seems to make sense that federal law for many things should prevail over state. I realize this is not always the case like with state pot laws. There may be areas where state laws make more sense to be operative over federal ones. I don’t think stem cell therapies is such an area.
Allegedly, Beeben had very inappropriate remarks to someone found here:
https://www.reddit.com/r/stemcells/comments/1hw3cvv/platinum_biologics_a_kind_levelheaded_exchange/