Utah appears ready to pass a new stem cell law that would explicitly allow clinical use of non-FDA-approved placental cell drug therapies in the state.
Bill 199 seems likely to set up a conflict with the FDA that may land in court. The key part of the bill says:
“A health care provider whose scope of practice includes the use of stem cell therapy may perform a stem cell therapy that is not approved by the United States Food and Drug Administration.”
Some very odd things about the bill point to possible motivations behind it and risks to state residents. Note as an update that this bill was signed by the governor so there is now a Utah stem cell law in place.
Utah stem cell law on collision course with the feds?
It’s striking that these state lawmakers think they can just legalize cell therapies that in some cases are likely illegal at the federal level. Note that the FDA has repeatedly said that placental cell therapies are drugs requiring premarket approval. It’s even taken oversight action on this front.
Maybe the Utah folks behind this bill are hoping the eventual new law will be akin to many states okaying marijuana use. Even though such use is not permitted at the federal level, the feds largely do nothing.
Yet I have a hard time imagining the FDA would tolerate this potential situation in Utah. Such passivity could undermine FDA authority.
Problems and complications with this law
Another problem with the feds letting a law like this stand and not enforcing federal law is that in that scenario it is unlikely to be the last such law. Other states are probably more likely to follow suit with their own state laws if the FDA lets Utah do this unchecked. For example, I can see Texas passing a new law on stem cells that may be highly permissive. Texas already has an unclear legal climate on stem cells due to state laws there.
As to the Utah bill, why is it focused on placental cells and not others like umbilical cells? To me this suggests some specific commercial interest in Utah has been driving this bill. Who sells placental cell therapies in Utah? Is it a clinic firm directly treating patients or a biologics producer who might be pushing this? The law seems more focused directly on clinical use of non-FDA-approved placental cell drugs rather than their production.
For background, Utah biologics producers have already been subject to FDA action.
- FDA warning to Predictive Biotech
- FDA warning to stem cell clinic supplier Utah Cord Bank
- ‘Bottom of stem cell barrel’? Utah piece sparks legal threat
Utah also has many stem cell clinics that to my knowledge haven’t drawn FDA action yet still raise concerns to me including Docere Clinics. The chain R3 Stem Cell also has at least one or more clinics in the state. Check out: Fact-checking troubling R3 Stem Cell clinic chain.
Signage and consent
The Utah bill has a provision for requiring signage and patient consent in the context of using non-FDA-approved placental cells. However, there seems to be a loophole in the wording in that something called “the division”, whatever that is, can say it’s not necessary.
I’m guessing various firms would claim expertise and be granted exemptions. One or more businesses behind this bill may have wanted this exemption in it.
Other states including here in California and Washington State have real signage requirements for stem cell clinics, which is a good thing.
Looking ahead
Overall, I see the Utah stem cell law as causing a bunch of trouble and leading to a state vs federal court case.
Ultimately, Utah would probably lose such a case, but it could take years. In the meantime, many people could get highly questionable, expensive placental tissue “therapies” in Utah.
I wouldn’t be surprised to see other states come up with similar bills during the same period, maybe with their own twists like okaying sketchy umbilical cord cells or unproven exosomes.
There have literally been hundreds of thousands of msc and exosome treatments in the USA and worldwide. There are hundreds of clinical reports showing the efficacy of both stem cells and exosomes and also prp. The FDA is being pushed by pharma and medical device companies to not support these products and treatments. Stem cells derived from umbilical and placental tissues are the building blocks to all life and can actually help in many many ways. If you can save someone from having a shoulder surgery or knee surgery that is amazing and wonderful. If stem cells and exosomes can help with anti-aging treatments and possibly replace the neurotoxin botox then that’s great news. The FDA should put in place regulation around the safety of the processing and allow physicians to use the products as they see fit.
Stem cells and exosomes are some of the best products there are for certain ailments and need to be used and researched more and more.
Good job to Utah and the Utah legislation for pushing this healthy treatment forward for doctors and patients to look into and use further.
One last thing to consider…blood transfusions aren’t FDA approved, yet are very beneficial for people who need blood.
@David, do you have any evidence on your big pharma conspiracy theory?
The FDA has approved the clinical use of umbilical cord derived stem cells and exosomes administered intravenously for the treatment of Long COVID via their Expanded Access Program: vittilonghaul. Clearly, the FDA has identified a lab that has developed perinatal tissue products that are both safe and efficacious.
@Kristin,
It’s not quite that simple. It seems they just have an IND to do clinical trial work. It doesn’t mean it works or is definitely safe. Admittedly, getting an IND is an important positive step, but it’s not the end of the story. I’d also note that just 2 years ago this firm received an FDA warning letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vitti-labs-llc-627699-07282022. I hope the IND is a sign of things moving in a positive direction.
Paul you said they’re not going to legalize umbilical cord mesenchymal stem cells, you said Utah is only going to legalize placenta derived stem cells. Are you sure on that? Because the umbilical cord is considered to be part of the placenta. The umbilical cord is part of the placenta.
I am pretty sure this bill also legalizes the use of umbilical cord derived MSCs in Utah. There’s a clinic in Park City, Utah run by Harry Adelson that literally uses umbilical cord MSCs. Are you saying they’re going to tell Harry Adelson he can’t use umbilical cord MSCs anymore?
I guarantee you the Utah lawmakers had Harry Adelson in mind when they made this bill.
And like I said when you read about the placenta it tells you the umbilical cord is part of the placenta.
I’m happy Utah made this bill, I think it’s time the American people get access to umbilical cord MSCs. I think the FDA has too much power is what I think.
You think Big Pharma doesn’t have influence over the FDA? You think the health insurance companies don’t have some sway over the FDA? And let me tell you, the health insurance companies are downright corrupt. The health insurance companies basically have full control over our health care in the USA, they decide what treatment we get.
So oxycontin is basically heroin in a pill, it’s basically heroin and it’s very addictive and it’s killed hundreds of thousands of Americans at this point. The FDA official who approved oxycontin, then quit his job a year later and went to work for the pharmaceutical company that manufactures oxycontin, and they paid him a nice big fat salary. I know the pharmaceutical company that makes oxycontin has been sued by the government. And the FDA official who approved oxycontin I believe is being sued right now.
Great news. A huge leap forward. All the people on this thread pretending to care think the fda has their best interest in mind. 😂
Yes! I mean how could the FDA have our best interests in mind? Good point! After all, most of the FDA’s budget comes from the very special interest groups who fund their coffers…specifically big pharma and the medical device manufacturers. (Talk about a public private partnership!!!!) Next thing you know, folks on this blog will be telling us that our elected “representatives” (senators, congressmen/women) who also receive money from special interest lobbyists have our best interests in mind as well. Ha!
OK, you don’t like the FDA. No shocker there. How about some common sense ways to make things better in the cell therapy area? That’s harder.
That you and others on this blog come across often times as apologists for the FDA (and the ISSCR) No shocker there either. After all, FDA is a strong supporter of primarily long drawn out basic scientific research of which you are heavily involved. So,…. what COMMON SENSE ways to bring about cellular therapies to the masses? …. Adult stem cells need not be regulated as drugs. (DUH!) The regulations that turn our body parts into pharmaceuticals slow medical advances down. Greater progress for patients probably would already have been made if the FDA had not stuck their nose into the practice of medicine. And words like “more than minimal manipulation” and “homologous use” (hardly scientific) were essentially made up on the fly thwarting progress already taking place with ASC’s. (mostly in the field of orthopedics) Majority CLINICAL as opposed to BASIC research would be far more productive for patients relative to stem cells. FDA and ISSCR supporters don’t seem willing to go there. Why would they? The system of securing new grant dollars over that which leads to therapies seems to work pretty well for them…..and you. The FDA is too big and powerful and this has led to corruption in the form of regulatory capture. Reform is out of the question as FDA is not accountable to the people and have turned into less of a regulatory body and more into an agency of prohibition…particularly with regard to ASC’s. HOWEVER, another solution could already be in the making given the Utah decision. Perhaps the FDA will get broken up in a manner similar to what happened in the 1980’s with regard to the telecommunications monopoly. Many separate state medical boards (50 of them) might be harder for big pharma to corrupt than a single federal entity. It’s not as though what I’ve written here has never been addressed before. For more ideas, try the following link. https://news.asu.edu/content/crow-calls-national-institutes-health-redesign
Medicines can’t be approved by a popular vote. That’s why there are dedicated scientists who develop new therapies and a regulatory agency that gives us the chance to test them in first-in-human trials. Don’t dismiss how hard we’ve worked for knowledge – I made $400 a month getting my PhD, and was eligible for food stamps. As a full professor, I made less than $200,000 a year (the highest salary allowed by NIH), all of which I had to bring in myself from grants. I’m not complaining- it’s an honor to mentor young scientists, to make discoveries that are important, and to plan a pluripotent stem cell-derived neuron replacement therapy for Parkinson’s disease that is about to start clinical trials. Ask me anything you want to know, from a scientist, about stem cells.
This will be a very large problem, as it conflicts with Federal Law. It should be unlikely that the current Supreme Court would uphold the law, if any level of “Originalist” thought is applied.
AABB and FACT both REQUIRE the facility or institution to comply with Federal Laws. One cannot have accreditation without said compliance. So in those parts the law itself becomes a catch 22.
Of the several issues with the wording of the bill is the clause “(iv) an entity with expertise regarding stem cell therapy as determined by the division.” It is ambiguous as to what this statement means, or how it will be determined.
The fact is that these ‘clinics’ are not designed to bring life saving or even improving treatment options to patients in need. They are specifically designed to make profit and profit off of the hopes and fears of patients. History is fraught with people being taken advantage of, and not being given full disclosure of risks, of effectiveness, or outright harm. Worse, many of these ‘clinics’ have indemnification hidden deep in the contract that bars a client harmed from the ‘cellular treatment’ from suing or talking about said harm.
So with those large warnings in mind, it seems this is truly a dark day for medicine, not a bright beacon of hope at all.
While federal law may prevail over state, this could take years. Let’s say the Utah bill passes and becomes law in coming weeks, and clinics there start to conduct stem cell business explicitly based on the new UT state law this summer or fall, violating FDA regulations. No joke, the FDA might take a year to conduct an inspection at one or more such UT clinics, then some months later it perhaps issues a warning letter, and maybe the clinic businesses reply that they are following Utah State law. Then what? Does the FDA seek an injunction? They’d probably win but the risk if they were to somehow lose is huge even if it is overturned on appeal. Let’s say the FDA does go for an injunction, it could take a few more years for the case to get resolved. Do they get a temporary injunction earlier on? I hope so. If not, meanwhile, people are buying useless placental “stem cells” and being put at risk of infections, etc. Now imagine 5-7 other states follow Utah’s lead on state laws on stem cells that outright conflict with federal law/FDA regs, prompted by clinic firms in those states and other parties opposed to FDA oversight. What a mess. For this reason if the Utah law passes the FDA needs to act very quickly somehow if it’s possible.
Well said, StemCellSciGuy, whoever you are!
The ultimate cause of this is the Federal government not enforcing federal laws. Once states were permitted to ignore federal laws, a Pandora’s box opened. California thinks weed should be legal. Alabama thinks abortion should be outlawed. Oregon thinks hard drugs are fine. Utah thinks stem cell clinics are ok. It’s all unicorns and rainbows when a state ignores a federal law with which a particular constituency disagrees. Of course, it’s a different story when a another state does something that constituency doesn’t like. The solution is for the federal government to enforce all federal laws or else cede more control back to the states. I’m for the latter personally.
You obviously have never seen a family member. Suffer with multiple sclerosis ALS parkinson’s disease or any other crippling ailment. Which stem cells can be a therapy for and end the suffering.. This is no different. Then the law. It’s my body. It’s my choice. I can have an abortion in some states up till the 8th or 9th month. Even but I can’t take the chance of having stem cells. Put in my body to end the suffering of the blasted disease that cripples me doesn’t allow me to walk. Doesn’t allow my bladder to function properly. You have no clue what you’re saying. The United state’s FDA can pass a COVID vaccine. That’s a bunch of bull crap inside 18 months. They can pass a pill to help prevent HIV and make HIV undetectable. But they’re not willing to take the chance on stem cells kudos to the state Utah , it may cause me to move if passed.
Huh?
I am truly sorry that you think that stem cells offered by unregulated clinics can help you. They won’t. They can’t. It’s scientifically impossible, which is why the hundreds of clinical trials using “stem cells” have never resulted in approval by the FDA. The FDA isn’t always right, but they’ve had plenty of experience with judging trials and they know what they’re doing. I hope you don’t turn to a charlatan to give you hope. There are real clinical trials using real stem cell-derived dopamine neurons to replace those lost to PD. I wish they’d go faster, but you could try to get involved in the BlueRock trial that is going forward now.
Great points. The people on this thread want to control medicine and trust the FDA to do the right thing 😂.
Hooray for Utah! Hopefully more states will follow soon.
As a multiple sclerosis sufferer for 35 years. Yes yes pass it if it would I would move
Dear Michelle,
And that is the problem. Many people might do just that… travel or move. And then many would try these ‘treatments’ only to find out what most others who have done so find out: That they don’t work.
Then you would have uprooted your life, your friends and family, your job, your house… everything. And be left with a bill for a service that didn’t help your MS at all. All after a promise from a facility that will bar you from actually telling anyone that it didn’t work (or worse) and with no legal recourse to seek compensation.
That is the problem.