New Florida bill mixes RTT spirit with turning unproven stem cell sales into a felony

Florida stem cells
Just a few of the many stem cell clinics and other entities in Florida found by Google Maps
Florida stem cells
Just a few of the many stem cell clinics and other entities in Florida found by Google Maps

A new Florida bill (Bill 65 of 2019) could make the practices of stem cell clinics a felony. At the same time it would open the door to patients receiving still experimental stem cells that have at least started the clinical trial process.

What’s going on?

A number of states have been stepping up action related to stem cells and specifically stem cell clinics. The steps on unproven clinics range from bills, some of which have become law such as here in California and Washington State, to increased medical board activity. The law in Texas on stem cells leans more pro-clinic and has a right-to-try (RTT) feel too. There has also been action by state attorney generals. Apparently representatives in Colorado might pursue a bill there too bearing on stem cell clinics.

Florida is a hot mess on the stem cell clinic front so it needs to do something and quick. You can see a map above of where GoogleMaps indicates there are stem cell firms in Florida. There are far more clinics than that based on data from more comprehensive web searching.

Florida at one point had a bill to rein in stem cell clinics, but it died in committee. The new piece of proposed legislation, Bill 65, has an unusual mix of provisions. It’ll be interesting to see the results if it becomes a law. It is sponsored by Democrat Joe Casello and Republican Chuck Clemons. I doubt these guys sparked the idea though so I bet someone else is the driving force behind this. I just haven’t been able to figure out who yet.

Bill 65 will likely change over time, but if something like the present version became law, then selling unproven stem cells in Florida would specifically be a felony. The bill also has other common sense provisions such as requiring licensed physicians to be the ones administering stem cells and only permitting this practice at certain types of locations. At the same time it also provides for patient access to investigational stem cells that are part of clinical trials with FDA cleared INDs. This essentially would be a type of stem cell RTT. In my view, it’s hard to imagine any clinics being able to take advantage of that since they don’t get FDA-cleared INDs or do real clinical trials.

The bill further provides protections for physicians from state action against them if they do inject investigational stem cells into patients on a not-for-profit basis. Interestingly, I found a law firm describing the new bill and indicating to potential clients that it’d be a good idea (for unproven clinics?) to get legal representation.

I asked attorney and bioethicist Beth Roxland, an expert in health policy matters with many years’ experience in the stem cell arena, for her overall take on the new Florida bill. She provided this helpful overview:

“This bill follows the overall trend of very ill patients understandably wanting earlier access to potentially promising therapies when no other options for them exist and the timeframe for full development and regulatory approval may be years away, as well as patients’ increasing desire to make autonomous decisions and their willingness to take on additional or unknown risk. While Florida’s proposed legislation contains clear attempts to foster greater legitimacy, safety, and local oversight of stem cell interventions, the bill’s questionable legality, its narrow applicability only to adult stem cell interventions that are currently being studied in FDA-approved clinical trials, and its lack of detail on key aspects of interactions with patients and with the government, arguably could hinder rather than help speed promising therapies to market, while also leaving the many stem clinics flagged as ‘problematic’ untouched.”

Roxland also pointed out some other important elements of the new bill include its striking similarity in some respects to Texas’ Stem Cell Right-to-Try law (HB 810) and, interestingly, the unique provision for Osteopathic Medical Board oversight, perhaps an indicator that those sponsoring the bill are aware of the problem of some Florida osteopaths selling unproven stem cells.

She also noted that despite the prohibition on profiting off of selling stem cells in the bill, clinics potentially could try to work around that by charging exorbitant service and other fees. This could also make access to the stem cell interventions – which are explicitly not mandatorily covered by insurance – impossible for patients without substantial financial means. I’ve covered stem cell treatment costs here on The Niche a numbered of times, including average costs for patients and polling.

Overall, it’s hard to predict whether this Florida bill, should it become law, would be a net positive or negative, but I’d lean toward the former. The clinics are likely to fight it and should it become law, they may, as alluded to earlier, try to find loopholes to still make money off of vulnerable patients. I’m guessing more details of the back story will come out and it’ll be worth following how this bill evolves.

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