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Utah stem cell law OKs non-FDA approved placental cell drug therapies likely sparking conflict – The Niche

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 Rep. Katy Hall, placental cells
Rep. Katy Hall is co-sponsor of a Utah state bill that would legalize placental cell therapies that in some cases are likely not legal at the federal level.

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.

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.