I think the FDA has been holding its breath on one level for about two years.
How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them up to take much-needed action in this “stem cell” arena.
It’s great news.
A big win for the FDA in a pivotal stem cell case
Today the 9th Circuit Court gave the agency the authority I thought it always had. The federal judges ruled in the FDA’s favor on the appeal of what I’ve been calling the Cell Surgical Network lawsuit.
In the original case, a federal judge here in California had earlier ruled for the stem cell clinic defendants. Judge Jesus Bernal had ruled that the FDA could not regulate adipose cell therapies as a drug. This product is called stromal vascular fraction or SVF.
I think that original ruling was wrong for several reasons. Now the 9th Circuit Court agrees with the agency. Here’s the adipose cell ruling by the 9th Circuit Court.
I’m not sure the feds had much of a chance with Bernal in the original case. To me he seemed biased against the agency from the get-go. Now the 9th Circuit effectively overruled Bernal.
Florida and California cases cohere
The appeals court victory for the FDA here in California is consistent with a similar case on adipose cells, sometimes called SVF or “fat stem cells”, in Florida.
In the Florida case the FDA had won an injunction against the firm US Stem Cell over their unapproved use of SVF. US Stem Cell Clinic appealed, but the FDA won that appeal as well.
SVF is now definitively a drug. The FDA can regulate them as a drug throughout the US.
This is important for several reasons. In Florida and another state, some patients who received SVF lost their vision. There have been other side effects as well.
What this means for the FDA and the clinics
Many have wondered whether this lengthy case and the uncertainty it brought had led the FDA to be more cautious in taking action in the stem cell clinic arena.
The main uncertainty now is whether this case could be appealed to the Supreme Court. In the meantime, will the agency be bolder in actions related to unproven cell therapy clinics? I hope so.
It’s also possible the clinic industry will pivot and focus more on other cells. For instance, we could see adipose cell clinics begin marketing birth-related cell preparations. However, the FDA has been very consistent that those therapies are also drugs and I think they are on even firmer legal ground there.
For that reason, could fat cell clinics shift to marketing bone marrow, which in an unmodified form does not appear to constitute a drug?