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FDA to end ‘grace period’ on stem cell clinics: agency should ‘go big’ on continued offenders

Stem cell clinics violating federal regulations have been a major problem for the FDA.

Next month the FDA faces a historic moment on this problem.

A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that.

Some of the worst clinics are clearly violating federal law. Hundreds overall are trying to get rich off of vulnerable patients selling unapproved drug products.

What happens next?

Things could look dramatically different in just a few months, but it’s not a sure thing.

stem cell clinics map
Stem cell clinics map in 2016 in the U.S. based on Leigh Turner and Paul Knoepfler research data.

Stem cell clinics and the FDA: a mini-history

Let’s step back for a second to talk about how we got here.

Prior to 2010, most unproven stem cell clinics were outside the US, but that quickly changed.

Leigh Turner and I documented in our Cell Stem Cell paper that by 2016 the US had become an international hub for these kinds of clinics. You can see a map related to our continued analysis of data. Each indicator was a stem cell clinic.

He and I have both done additional research since then on these clinics. This includes my paper tracking the same stem cell clinics over time. Leigh reported in new research that the number of clinics continued to go up dramatically after 2016. Now there are likely around 1,000 such businesses in the U.S.

Despite earlier warnings to the agency by Leigh and I and others, the FDA was slow to address the stem cell clinic problem. That slowness was part of the reason for the explosion in risky clinics.

Fortunately, over the past 4-5 years the FDA and its Center for Biologics Evaluation and Research (CBER) have stepped up to tackle this situation. Much of the credit goes to Dr. Peter Marks, CBER Director. He and his team along with past FDA Commissioner Scott Gottlieb strongly engaged on the stem cell clinic problem. That positive trend continues.

Still, it was somewhat frustrating that after the FDA issued formal guidances on stem cells and regenerative medicine (which clearly indicated hundreds of clinics were non-compliant) that the agency then decided to give clinics a three-year period to come into compliance. The period was also extended further by six months.

Now that grace period of 3.5 years is slated to end next month. Will it be extended again?

FDA will not extend grace period, has sent 350 letters

Peter Marks announced in a post on regenerative medicine this past week that they would not be extending the grace period again.

He also reaffirmed the agency’s commitment to tackling this problem. The tone of his article makes it clear that they are still very engaged on this issue despite the pandemic.

Sarah Karlin-Smith has a nice article on the FDA cell therapy discretion period ending at Pink Sheet, which I highly recommend.

One striking detail she reports is that the FDA has sent out 350 letters to various entities highlighting their non-compliant use of regenerative medicine products like stem cells in recent years.

This is vastly more than most of us outside the agency realized.

I thought the number might be more like 60.

What will the FDA do now? What should they do?

The big question now is what happens once the “discretionary” period ends in a few weeks.

I recently suggested to the FDA that they consider issuing warning letters to the highest-risk firms that have already received untitled letters during or before the grace period but remain noncompliant. In a sense those untitled letters are “mini-warning letters”.

I urged the FDA to issue the new warning letters without requiring themselves to first have done an inspection. Such inspections have traditionally been done before warning letters. The agency should also pursue injunctions against the most egregious violators. At stake is not just the agency’s credibility but also the safety of thousands of people.

Another potentially more practical option is financial penalties. Fines are on the list of FDA enforcement actions. Such fines could potentially be more readily pursued to dozens or hundreds of firms and send a strong message. After all, for many of these clinics the most important motivation seems to be money. I don’t know based on that FDA resource page whether civil fines could be issued.

How assertive will the FDA be?

The question of the scope and timing of impact largely will depend on how assertive the agency chooses to be.

Even a targeted set of strong actions like warning letters over the coming couple months against a few dozen of the riskiest firms could make a huge difference. It would send a clear message.

Going even further with injunctions, fines, or coordinated actions with state medical boards to take actions on the licenses of the physicians involved at the worst offending clinics for potentially violating federal law would do much more.

Frankly, I’m not certain that state medical boards will step up as needed, but regardless the FDA should pursue assertive action.

There’s really no excuse for clinics to continue being blatantly non-compliant.

And there’s no logical reason for the FDA to take piecemeal action or have a long period without decisive action after the grace period ends.

Patients’ lives, health, and money are at stake. These clinics also undermine the FDA’s mission.

I hope the FDA does ‘go big’ and starts quickly in May.

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