The FDA stem cell clinic problem just continues to grow, while the agency has been oddly quiet in this space for more than a year.

Its been a major disappointment, particularly as in recent years FDA leadership had implied that bold action was coming. Their own words spiked expectations that the agency would tackle unproven stem cell clinics in a bold way.

Whats going on and why the disconnect between words and actions lately?

Many of these unproven clinic firms unambiguously market unapproved drug products, seemingly in clear violation of the law. Some have been doing so for many years. We now know about numerous people hurt by specific clinics and indirectly by suppliers. Unproven stem cell therapy risksare clearer now than ever.

It was therefore refreshing to see FDA leaders use unprecedented language to describe the problem over the past 3-4 years. It seemed clear how seriously they took it. The expectation from the stem cell field was some kind of major action at least on the most egregious of the clinics.

The FDA further raised expectations when more than a year ago it let a discretionary period for firms marketing stem cells expire. No discretionary period means clinics have one less excuse.

Yet very little has actually happened on the unproven clinic front.

Maybe one or a few warning letters a year.Some untitled letters, which lack bite. Actually in 2022 the agency branch in charge of biologics, CBER, has only issued one untitled letter so far, at least thats in the public domain. See screenshot below. By comparison, last year by this time it had issued nine such letters. Clearly there is no shortage of firms that could receive untitled and even warning letters. Its not as though the FDA has run out of firms to send letters to.

How big is the problem now?

My colleague Leigh Turner and I published the first data on stem cell clinic numbers in the U.S. back in 2016. It shook people up. FDA officials told me it made a concrete difference to have data on clinics. Those numbers were in the hundreds.

Since that time, clinic numbers have grown again several-fold.

Leigh more recently documented over two thousand stem cell clinics in the U.S. Not all of these clinics are clearly noncompliant its clearly a vast problem that requires quick, strong action.

The leaderships own past words suggested some big steps were coming. Then Commissioner Steve Hahn and CBER Director Peter Marks wrote a 2020JAMA piece that was blunt. It ended this way (emphasis mine in the following quotes):

It is time for unproven and unapproved regenerative medicine products to be identified and recognized for what they frequently are: uncontrolled experimental procedures at a cost to patients, both financially and physically. Patients and their caregivers should feel empowered to report adverse events to help make sure that purveyors of unproved products are identified, and the FDA can take appropriate action to bring them into compliance and thereby help protect more patients from harm. This goes to the core of the mission to which the FDA is committed: promoting and protecting the public health.

A year earlier, Marks and then Commissioner Scott Gottlieb issued a strong statement on stem cell clinics on the FDA website. The key phrase was this:

And we will not shy away from taking further steps when we see bad actors taking advantage of patients, and putting them at serious risk, for their own financial profit.

Again, no shortage of bad actors out there for the agency to act on.

Then a few months later the FDA issued a warning on stem cell clinics including this strongly-worded passage:

some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful. And the FDA is increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics

Illegal is a very strong word for the agency to use. Again, this seemingly totally conflicts with the little that has happened in the way of FDA action lately.

So why the minimal enforcement actions in the past thirteen months, especially since theres no enforcement discretion these days? Seems like a paradox to me. There might be some complexities here.

What about COVID? A recent JDSUPRA piece reporting on statements at events byFDA Chief Counsel Mark Razaand Dr. Wilson Bryan suggests COVID could have been a delaying factor. The piece is entitled, Unapproved stem cell therapies remains a top FDA enforcement priority. Heres a key quote:

Coming out of the COVID-19 pandemic, we expect to see more enforcement activity around claims/promotion of stem cell products and manufacturing compliance and quality of such products, likely to be focused on scenarios that present the highest or significant potential risk to patients and consumers.

This is just one possibility. I hope theyre right though. Also from the same piece:

At a recent regenerative medicine webinar, CBER Office of Tissues and Advanced Therapies (OTAT) Director Wilson Bryan, M.D.,saidhis office has been increasingly notifying, warning, and taking legal enforcement actions against manufacturers, clinics, and individuals administering unapproved regenerative medicine therapies.

Does increasingly refer to the past 3 or years or just more recently? The link embedded in that quote also goes to FDA text that has some very strong language from Bryan just last year on some clinics and activities being illegal.

From Raza:

Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Acting Chief Counsel, discussed the investigations priorities for FDAs Office of the Chief Counsel (OCC), including its focus on stopping stem cell clinics that put patients at risk.

That sounds encouraging.

Beyond possible COVID issues or delays, another possible scenario here is that more has been going on behind the scenes on clinics. The FDA just hasnt told us about it or it hasnt reached fruition. Maybe theres a whole lot of investigations ongoing?

What else might explain the FDAs concerning lull?

Cell Surgical Network Lawsuit. There is that seeminglynever-ending court case with the FDA seeking permanent injunction on a California-centered stem cell clinic chain. Is the agency waiting to see the verdict? In a way that court case only or mainly pertains to so-called fat stem cell clinics. There are many hundreds of noncompliant clinics that seem unrelated to that case. Numerous suppliers too.

The FDA also only relatively recently got a new Commissioner. Robert Califf came on board again for a second term just four months ago. Sometimes a change in leadership can delay groundbreaking action by an agency for at least a little while.

Whatever has been going on, this lull has serious risks to the public. Also, Id say its not great for the agency either if it is seen to seemingly be passive on non-compliant and in some cases obviously unlawful stem cell marketing. Its especially bad timing for an enforcement discretion period to end and then almost nothing happen for more than a year after that.

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Did COVID derail FDA stem cell clinic plan? - The Niche