FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite.
During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I can tell there’s been radio silence from him on the massive problem of unproven stem cell clinics in the U.S.
As many of you know, this unproven cell therapy industry is not only a problem for the public and the stem cell research field but also for the FDA itself. What does it say about the agency’s authority if it just sits by as many hundreds of biologics firms violate regulations and in many cases the law? And the Commissioner says and writes nothing about it?
Since the stakes are high here, what explains this apparent lack of engagement by Califf on the stem cell clinic problem?
Some of the possibilities raise major concerns.
Previous FDA Commissioners were vocal on stem cell clinics
By contrast to Califf, previous Commissioners in recent years have been vocal about this issue, which is great.
For example, during his tenure, former Commissioner Scott Gottlieb issued numerous press releases on stem cell clinics and authored papers on the topic. Here are some past posts talking about instances where FDA Commissioners wrote or spoke out about this problem:
- Take-homes from new FDA NEJM stem cell piece including surprises
- FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely
- Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine
- How Scott Gottlieb may transform the FDA’s approach to stem cells
Former Commissioner Steve Hahn also regularly talked about unproven stem cell clinics.
Is the stem cell clinic problem not a priority for Robert Califf?
What does it mean that by contrast Califf has, to my knowledge, said essentially nothing during his second time as FDA chief about this pressing issue? Action is more important than words, but magnifying the concerns about this silence, the FDA has done very little to combat unproven stem cell clinics during Califf’s recent tenure too.
Note that during Califf’s first time as FDA Commissioner, the stem cell clinic problem was far smaller but the FDA did almost nothing about it then either. He said very little too. Back then in 2016 we got this from STAT: FDA chief pushes back against criticism of stem cell treatment regulations. That was almost 8 years ago.
So in the long run is this issue just not a priority for Califf? If it’s a low priority, why?
On the other hand, could it be important to him, but he’s waiting for some “right moment” to speak out? Do something? Is he waiting for some pending major FDA action on stem cell clinics? Waiting for resolution of the agency’s appeal of a court loss on fat cell clinics that’s pending at the Ninth Circuit?
Saying a lot but not about stem cell clinics
Maybe Califf just has a different leadership or communication style than past FDA chiefs where he doesn’t say or write much about anything? That doesn’t seem to be the case. You can see in a PubMed search that Califf has been actively writing papers during his second stint as Commissioner. Just none on stem cells or regenerative medicine.
The agency also has a blog called FDA Voices, where Califf has occasionally written about important issues. His FDA blog entries haven’t touched on stem cell clinics as far as I could see.
In addition, the FDA regularly used to do press releases accompanying important actions related to unproven stem cells. I haven’t seen any of those recently. On Google News and just plain Google as well as other internet search engines, I couldn’t find any statement from Califf about stem cell clinics in the last few years either.
Califf and CBER Director Peter Marks published an editorial on biologics and the need for strong clinical trials in Science Translational Medicine last year, but surprisingly it didn’t mention cell therapies or stem cells specifically.
Looking ahead
Of course, our arena is not strictly speaking only facing a stem cell clinic problem. Both clinics and manufacturers are engaging in non-compliant activities with other cell therapy materials including perinatal cells that aren’t stem cells and unproven exosome therapy. I don’t see anything from Califf on those either.
So what gives?
Does this silence mean there will continue to be very little action too on this problem? I politely asked Califf about doing more on stem cells on Twitter/X recently but got no reply.
This clinic problem is not just going to go away even if you don’t give it attention.
While the FDA is asleep at the wheel, one attorney in the New York AG office filed a major case against Joel Singer, M.D. and his stem cell fraud operation ans she won a $5 million judgment—and Singer was put out of business. As we know, the fraudsters use the scientific language to confuse potential patients. The incentive—it is a CASH ONLY business. I am hoping that FDA leadership takes aggressive action to protect the public. Such action would also protect the integrity of legitimate stem cell research.
So i have listened to the oral arguments of that appeal at the 9th circuit; and yes, I suspect that is what he is waiting for. The issues there are so stark, and so antithetical to the FDA position (which has basically been upheld by a different Circuit Court) that a loss here could completely upend the entire field. There is no real science behind the California Stem Cell position that the FDA can’t regulate them, although the record contains some (poor) arguments. It is basically a kind of libertarian attack on the FDA’s ability to regulate in general. This circuit is not likely to take that position, but they could. It is a 3 judge panel, so if the FDA looses they can appeal to the entire Court. Otherwise the only appeal is to the Supreme Court, and who knows what those guys would rule. There’s probably at least 4 votes against the FDA there, right now. So if the FDA is going to wade into stricter regulation before that decision, they would be wise to do some forum shopping and case shopping to differentiate it from this one.
@Richard,
Good points. I know it’s not simple for the FDA to take large-scale action, there are risks to that, and the timing is important, but I also worry about the FDA’s commitment to this problem. In another context, we saw FDA leadership as quoted that people who have been harmed maybe should turn more to states to address problematic clinics.
Just maybe the FDA- stands for FOOD and DRUG ADMINISTRATION..
Not Food, Drug, and complient 361, ie.(Non -Drug Immune privileged as with many other positive benefiting effects).
Have you checked all the 351- drug based stem cell studies, they do have over site in their INDs.. hence FDA is doing their job.
The regulations are in place, don’t keep misrepresenting the word stem cells as a catch all phrase, IT’S NOT!