He found more than 2,700 clinics run by more than 1,000 firms in the U.S. This is several-fold growth since 2016.
I’m very glad that Leigh has continued this line of research.
Stem cell clinic industry is still growing fast
One major conclusion is that the FDA’s approach just has not worked overall.
They’ve stepped up their game in the last 4-5 years, but it seems clear that sending out more (but still relatively few) warning letters and churning out hundreds of untitled letters just isn’t enough.
Another lesson is that it seems the FDA’s more than three-year grace period (technically a period of “enforcement discretion”) for clinics to come into compliance was specifically a major misstep.
Leigh’s new data tell a story of a largely rogue industry that continues to mushroom in size across the U.S. despite challenges to them like the pandemic and the FDA being more aware of the problem.
It’s worth noting that this industry could potentially go by some kind of new name because there are far more than stem cells sold at these clinics. One growing area is exosomes, which are drugs and require premarket approval from the FDA.
Then there are many other non-stem cell products, some of which are still called “stem cells.” Some of these products don’t even contain live cells of any kind.
New stem cell clinic oversight ideas: fines & more
What to do now?
I wrote earlier this year that the FDA stem cell clinic approach needs a radical overhaul.
Fines. Perhaps the best way to proceed is to issue monetary penalties against many hundreds of non-compliant clinic firms. The first of such waves of fines could go to the 500+ firms that have received untitled letters from the FDA and who remain noncompliant. The bottom line for the clinics is making money so regular noncompliance fines of $50K or $100K would have major impact.
Warning letters without inspections. Another idea is to issue hundreds of warning letters to these and other firms. Warning letters are a more serious regulatory step potentially leading up to filing suit for injunctions to stop clinic businesses. Traditionally the FDA has done in-person inspections before issuing warning letters but that isn’t practical for such a large industry and in an emergency kind of situation, which I believe this is. For this reason I suggest the agency break new ground and issue warning letters without requiring themselves to have done an in-person inspection.
It would also help if state medical boards did far more.
More oversight ideas: injunctions & PSA campaign
More injunctions. Ultimately, the FDA might have to find a way to issue relatively large numbers of injunctions working together with the DOJ, but there are serious obstacles to that including the need for a huge legal team. Still, it is doable if there is the will.
I believe the FDA is currently in a waiting game on this front to see the verdict in federal district court in California on the suit it has filed for injunction against a large chain of clinics.
Public service announcement ad campaign. Finally, with thousands of clinics out there and the industry still growing it is time for a national PSA ad campaign by federal agencies to warn the public about this problem.
Given the size of this industry the risk to the public is huge and the industry threatens the authority of the FDA itself.