New FDA Commissioner Marty Makary has brought on Dr. Tracy Beth Hoeg (or Høeg) as a special assistant.
Hoeg has had some controversial views on COVID. She has seemed skeptical of certain elements of vaccination, masking, and school closing.
What struck me is that she also has offered unproven cell therapies at a clinic here in Northern California. Recall that RFK Jr. seems very interested in de-regulating some types of unproven cell therapies.
With all of this in mind, could Hoeg be an FDA ally to unproven cell therapy clinics? It’s an interesting question but the answer is not simple.
Tracy Hoeg offers unproven cell therapy at clinic
The clinic where Hoeg provides care, Northern California Orthopaedic Associates, performs many traditional, proven orthopedic procedures. Hoeg does those as well. These are not controversial.
However, the website indicates that she also uses a variety of unproven regenerative medicine approaches. From her page on the clinic website:
“She will also discuss the evidence for/against injection treatments she offers, mostly done using ultrasound guidance, including dextrose prolotherapy, corticosteroid injections, hyaluronic acid injections, platelet rich plasma and bone marrow aspirate concentrate injections.”
Let’s focus on those last two that I emphasized. Platelet rich plasma (PRP) and bone marrow aspirate concentrate injections are not proven effective for orthopedic conditions. While these approaches have their fans, they are not standard of care. For that reason, insurance and Medicare generally do not cover them.
Hundreds of clinics across the U.S. offer these and other unproven regenerative approaches. The FDA has struggled to find its footing in this space.
Unmodified marrow and PRP are generally not biological drugs
Still, there hasn’t been much of an issue between the FDA and clinics marketing bone marrow aspirate and PRP. There are logical reasons for this.
First, most often these specific biologics are not defined as drugs. As a result, the agency doesn’t require drug-level data for their use. The agency also doesn’t require those marketing these products to first take difficult steps like getting INDs or a BLA.
Second, there just haven’t been many reported negative outcomes with these products. They seem mostly safe in the orthopedic sphere. Nothing is entirely safe, but I haven’t seen signs of repeated major negative outcomes with PRP or marrow cells specifically for orthopedic applications. I can’t really think of any off the top of my head.
A few clinics and doctors in the U.S. do appear to me to misuse bone marrow cells and may even be using the cells in ways where the cells may be unapproved drugs, but it’s relatively quite rare and not for orthopedic conditions.
Overall, since I’ve been doing The Niche since 2010, the FDA has been relatively hands-off on PRP and bone marrow cell products, unless they are grown in a lab.
Could Tracy Hoeg be an FDA ally to unproven clinics?
By contrast, adipose cell and birth-related cell clinics and suppliers have been in almost constant conflict with the FDA. Many patients have been harmed after getting injections of those products. When the FDA has talked about the stem cell clinic problem and “bad actors”, my sense is that it’s mainly referring to the perinatal and adipose clinic arenas.
Getting back to Hoeg, it’s hard to say whether as Makary’s aide she might take actions within the FDA that could help some unproven stem cell and regenerative medicine clinics.
I suppose she could advocate for the FDA to define even lab-grown bone marrow cells as non-drugs, but I don’t see any reason she’d do that. Perhaps she could work toward Medicare covering bone marrow aspirate and PRP?
It seems more likely that she was brought on because she already has co-authored papers with Makary, and has similar views as Makary on COVID policy. While most of her publications relate to COVID, she has also authored quite a bit of other research including on vision and marathon running that does not seem controversial.
I don’t see her as an obvious ally to the perinatal or adipose cell clinics or supplier firms.
Under Kennedy will the FDA favor perinatal cells?
For the most part, clinics using bone marrow and PRP injections also have not exactly been friends to clinics and suppliers selling perinatal and adipose cell products, and vice versa. There has even been some hostility between these groups.
While a few clinics straddle both areas and offer a wider range of regenerative cell offerings, most are in one camp or the other. So, in that sense, it could be a leap to imagine Hoeg being helpful to perinatal and adipose cell firms from within the FDA, especially given her regenerative medicine focus.
On the other hand, so far RFK Jr. seems most interested in perinatal cells so he could push things that way.
At the FDA Hoeg might just focus on vaccines and related policies, but we’ll see.
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- Source: https://ipscell.com/2025/04/new-makary-fda-aide-dr-tracy-hoeg-has-offered-unproven-stem-cells/?utm_source=rss&utm_medium=rss&utm_campaign=new-makary-fda-aide-dr-tracy-hoeg-has-offered-unproven-stem-cells
