Has the FDA given up on regulating stem cell clinics …

What the heck happened to the FDA when it comes to regulating stem cell clinics?

Has it given up?

Or does it just seem that way because it moves in slow motion?

The FDA might as well have thrown in the towelbecause, as I like to say, the stem cell field moves in dog years. Often times 7 years worth of stem cell happenings take place in just onehuman calendar year. An example of this warp speed is the approximate doubling of the number of stem cell clinics in the US in the last year or so.

There was a time when I was perhaps naive enough thatI thought that regulatory agencies legally tasked with oversight of biologics would take swift action against violators, particularly if the products or procedures in question were not proven to be safe or effective. Patients are at serious risk.

Throw in some evidence of predatory behavior and dubious public claims and lack of training at some clinics, and the FDA in the US, for example, surely would do something about it as thousands of patients get these dubious interventions. Right?

Im no so sure anymore.

I still believe in appropriate regulation of stem cell-based medical products and interventions.The FDA has now won their recent legal case on regulating proliferated stem cell products as biological drugs and it would seem they should if anything be energized to put the stem cell clinic sphere in order.

Cue crickets chirping.

The FDA appears at least on the surface not to be doing much of anything on stem cell clinics even as the number of dubious stem cell clinics in the US has stormed past 100. One problem right up the FDAs alley for regulation is that these places are selling and using unapproved products and devices, and in that way putting patients at serious risk. For example, as best as I can tell there has been no recent FDA action on stromal vascular fraction (SVF), a product that the FDA has, at least in the past, defined in no uncertain terms as a biological drug. Meanwhile more and moreclinics sell SVF treatments and it isspiraling out of control.

See more here:
Has the FDA given up on regulating stem cell clinics ...