June 4, 2020

The Niche

Knoepfler lab stem cell blog

As stem cell industry explodes, can a static FDA keep up?

FDA budget graphThere are legitimate arguments about the degree to which the FDA should regulate stem cell clinics and the point-of-care, for-profit stem cell industry. I’ve held debates about that on my blog with argument on both sides including a very valuable debate between Dr. Chris Centeno and Doug Sipp.

However, increasingly it is looking like the more important, immediately pressing question is not the degree of regulation that is hypothetically desirable, but rather whether the FDA is even capable of regulating this exploding industry appropriately no matter what any of us think about the degree of regulation.

Can the FDA, as it is currently funded and structured, effectively regulate the stem cell industry?

Unfortunately, the answer is “no” at this time.

A big part of the reason is the static FDA budget (see graph above left).

As most readers of this blog know, I am in favor of a relatively high degree of FDA regulation of stem cell treatments so I find the slow, incomplete response of the FDA cause for concern. But I don’t really blame the FDA itself because I believe given its budget and personnel there is only so much it can do. Keep in mind the FDA has a huge amount of other responsibilities beyond cell therapy-related biologics (the area in which stem cells fall).

We saw in a recent very helpful article by University of Minnesota professor, Dr. Leigh Turner that there are at least 20 stem cell clinics operational in the state of Texas alone. This does not even include associated businesses that may fall under FDA regulations. Thus, I’m not convinced that the FDA could even oversee all the stem cell clinics just in the state of Texas alone. Backing that up is the fact that we see overall relatively little regulatory action by the FDA on stem cell clinics. What about the other 49 states?

The FDA budget is a serious problem.

FDA stem cell clinics

The FY2012 FDA budget (the so-called “budget authority” which is the actual amount of money allocated from the federal government for the FDA and does not include fees the FDA receives from corporations) is approximately $2.5 billion, not much higher than it was all the way back in FY2009.  In the coming year reportedly  it could even face a sequestration-based cut of almost a third of a billion dollars.

Breakdown of 2012 FDA budget can be found here. For biologics, the category in which stem cell based products fall for regulation, we see no change in the number of FTEs from 2010-2012 and I suspect the number in 2009 was the same as will be the number requested for 2013. During this same period, while there is no hard data, I would estimate that the number of facilities (stem cell clinics, manufacturers, product developers, etc) in theory requiring FDA oversight has increased several fold.

So we have a static FDA budget, particularly in the last 3 years, and exploding stem cell industry. Together this is a recipe for serious trouble. See graph above with the red line.

The President’s FDA budget request for FY 2013 is again approximately $2.5 billion, which is really disappointing. The request for 2013 is only $60 million higher than the allocation in 2011.

Bottom line: something needs to change or the stem cell industry will by default become largely deregulated.

This will leave the FDA in a perpetual crisis mode only regulating those stem cell entities that are either highest profile or somehow deemed greatest risk.  I believe we may already be at a point where the FDA is operating this way and I don’t think that approach works. We recently saw the FDA come down hard on stem cell cosmetics with warning letters, but it issues relatively few warning letters for stem cell clinics that actually inject millions or billions of stem cells into patients.

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