Florida is a hot mess on the for-profit stem cell clinic front. My own state of California isn’t much better and actually has a great number of clinics, but more problems are coming to light in Florida, at least at this point. Now WLRN reports that a legislator in Florida has proposed a new bill to try to address some of the issues with the clinics.
Clinics selling stem cells in Southern California and Florida (left and right).
Many clinics in Florida are making money from vulnerable patients and in some cases have apparently caused them harm, including claimed and some documented cases of blindness. Meanwhile more clinics are opening all the time.
You can see maps of the many clinics in parts of Florida and Southern California from the 2016 Cell Stem Cell paper from Leigh Turner and me. In a new paper we just published we chart the temporal nature of the spread of clinics across the U.S. and you can see in the accompanying animated video how Florida is a definite hot spot over time.
According to the WLRN piece by Daylina Miller, entitled, “Tampa Lawmaker Proposes Crack Down On For-Profit Stem Cell Clinics”:
“Senator Dana Young said stem cell treatments are already heavily regulated by the Food & Drug Administration, but the rules allow less scrupulous procedures to fall through the cracks.”
I’m not sure about the “heavily regulated” part.
Young has sponsored a bill, SB 1508, which could make clinic businesses meet higher standards and, if it becomes law (as of July 1, 2018), it could have positive impact:
“If the bill passes and becomes law, stem-cell clinics will have to register with the Department of Health, have a designated physician on staff responsible for complying with all requirements related to registration and operation of the clinic, and comply with annual DOH inspections.
It would also dictate the Florida Board of Medicine to adopt rules governing advertising by stem-cell clinics and informed consent guidelines, and allow DOH to impose an administrative fine up to $5,000 per violation.”
In some ways SB 1508 reminds a bit me of our new law here in California requiring stem cell clinics to notify patients of various important facts and for the state medical board to monitor the situation, but Florida’s SB 1508 (should it be come law) would be more work to enforce and has more ambitious goal. Will it pass though?
I hope SB 1508 becomes law, but I have a feeling that it will face tough opposition in Florida and the odds may be against it passing. It’ll be interesting to watch what happens with the bill.
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 ekspresi dominan 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 4dukt 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 dilema 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.
Today the United States District Court of the Southern District of Florida entered a permanent injunctionagainst stem cell clinic firm US Stem Cell and co-defendants including U.S. Stem Cell Clinic. Patients have been harmedby the unproven treatments sold by these firms.
US Stem had lost the case a couple weeks back, but now we know the details of the permanent injunction on them by Judge Ursula Ungaro.
The order against US Stem, which is likely to be appealed, is appropriately strict in my first quick read through. I’d be curious of other’s views of it. Update: Here’s the FDA’s PR on the injunction.
I need to read it more carefully later today, but here are some highlights:
“The SVF Product is a drug within the meaning of 21 U.S.C. § 321(g)(1).” Again, SVF is a drug.
“Defendants violate the Act, 21 U.S.C. § 331(k), by causing articles of SVF Product to become 4dukterated within the meaning of 21 U.S.C. § 351(a)(2)(B), and misbranded within the meaning of 21 U.S.C. § 352(f)(1) while the SVF Product, or one or more of its components, is held for sale after shipment in interstate commerce.” In this case, the SVF drug was 4dukterated and misbranded.
“Defendants and each and all of their directors, officers, agents, employees, representatives, successors, assigns, attorneys, and any and all persons in active concert or participation with any of them, who have received actual notice of this Order by personal service or otherwise, are permanently restrained and enjoined under 21 U.S.C. § 332(a) and the inherent equitable authority of this Court from directly or indirectly receiving, manufacturing, processing, packing, repacking, labeling, and/or distributing the SVF Product, unless and until:” Here the court lists many conditions including getting a cleared IND for the defendants potential future use of SVF. My prediction would be that the defendants will not meet these conditions in the future and they’ll switch to something to focus on other than SVF. We’ll see.
The court also orders careful oversight of the defendants. They will be essentially examined (by an “Expert”) and regularly monitored (by an “Auditor”) at the defendants’ expense.
Defendants must correct CGMP problems.
Defendants must destroy their frozen stocks of SVF within 30 days. This may be a big one as my impression (I could be wrong) is that they have banked quite a few people’s SVF on a for-profit basis. Will they have to refund all those people’s money? From the injunction, “Within thirty (30) calendar days after the entry of this Order, Defendants, under FDA’s supervision, shall destroy any and all SVF Product that is in Defendants’ possession, custody, or control. Defendants shall bear the costs of destruction and the costs of FDA’s supervision.”
If the defendants don’t comply with the order, it will likely get very costly for them. If I understood the injunction text right, violations could result in tens of thousands of dollars a day in what seem to me to be fines: “If Defendants fail to comply with any provision of the Act, its implementing regulations, and/or this Order with respect to any of Defendants’ SVF Products and/or Defendants’ facility, including any time frame imposed by this Order, then, on written notice of FDA in this proceeding, Defendants shall pay to the United States of America: fifteen thousand dollars ($15,000) in liquidated damages for each day such violation continues; an additional sum of fifteen thousand dollars ($15,000) in liquidated damages for each violation; and further additional sum equal to the retail value of SVF Products.”
My impression in a general sense from having looked at the government’s proposed order submitted earlier in the evolution of this case is that the FDA got nearly everything it wanted.
I suppose this injunction could be overturned on appeal, but in my view as a non-attorney, I kind of doubt that.
What happens next?
I can’t be sure, of course, but I suspect in the end that a similar injunction will be put in place in the California case probably before the end of this year. What happens then to their scores of network member clinics? Presumably they will be subject to the same injunction as the Network if indeed the California case goes the way I think and results in similar language as the Florida one has.
State Medical boards may finally get engaged if doctors continue to sell unproven stem cells that are now unambiguously not permitted based on a federal court ruling. The Florida ruling may also be used in the many patient lawsuits against clinics, aiding the plaintiffs.
Some fat stem cell clinics are probably going to just switch to other unproven stem cell types, but it won’t be that easy. Many will drop out of the unproven clinic industry entirely. Other clinics may move overseas. A few might continue to try to sell SVF in the U.S. without FDA approval, but I bet not many and not for long.
Overall, this is good news for the stem cell & regenerative medicine field and for patients. Former FDA Commissioner Scott Gottlieb and current CBER Director Peter Marks deserve recognition for their hard work in this area. I see it as a victory for science-based regenerative medicine even as the larger conflict continues.
