Nevada has a relatively new 2023 law legalizing non-FDA-approved biological and gene therapies. I use the word “therapies” here loosely. They are not scientifically or medically proven to work or be safe so they could lead to substantial harm.
This is yet another early step in a likely growing trend of states challenging FDA authority on biologics. Nevada’s law resonates with Utah’s new law okaying non-FDA-approved placental stem cell therapies. We’re going to see more clinics using the state laws to try to justify selling dubious-at-best biologics and at worst, contaminated or otherwise risky junk.
As far as I know, no one noticed this Nevada law until a reader gave me a tip about it. Let’s go through it, the links to the Utah law, and the broader context.
Risky state laws on biologics
Both the Nevada law and the Utah stem cell law pose serious risks to the public. So why are these laws popping up?
They may reflect misguided efforts by lawmakers to increase access to unproven therapies. The broader right-to-try movement may also be behind this along with specific commercial interests. I’m not an attorney, but even I can see that these laws have major problems.
In both the Utah and Nevada cases, the laws do not necessarily require that the person getting the intervention have a fatal illness.
Further, the laws also potentially contain loopholes whereby clinics selling such unproven biologics can avoid restrictions or regulations.
The biologics in question also do not necessarily have to be produced in a specific way, potentially leading to CGMP concerns such as product contamination. In addition, I’m also unclear on whether Phase 1 clinical trials on the products in question would be required or not by the Nevada law. The language seems vague to me in that regard.
As a side note, it’s interesting that the new Nevada bill/law was sponsored by Democratic lawmakers. In most cases, we’ve seen the GOP moving such legislation forward.
Nevada biologics and gene therapy law
What are the details of this Nevada law? It permits broad kinds of unproven biological therapies to be used clinically. The law defines one particular phrase, “individualized investigational treatments”, in more detail:
“Individualized investigational treatment” means a drug, biological product or device that is unique to and produced
exclusively for use by an individual patient based on the genetic profile of the patient, including, without limitation, by an analysis of the genomic sequence of the patient, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products such as enzymes and other types of proteins or metabolites. The term includes, without limitation, individualized gene therapy, antisense oligonucleotides and individualized neoantigen vaccines.”
Why are those products that I bolded mentioned by name so specifically? On the other hand, terms like “proteins” are so vague and broad that they could include almost anything.
It makes me wonder who advised the Nevada state lawmakers on this bill. Could the Goldwater Institute have had a role here?
The quoted provision could do a lot of harm. For example, antisense oligonucleotide therapies could come with even life-threatening risks through altering gene expression. The Nevada law’s provision specifically mentioning oligo therapies brought supportive oligonucleotide therapy or SOT to mind for me. I have some big concerns about SOT.
Another puzzling thing here is that these biologics-related provisions were inserted into an otherwise medical records-centric bill. What’s the story behind that?
Conflicts with the FDA and federal law?
As with the Utah law, this new Nevada law would seem to allow activities that could run afoul of federal laws and regulations.
At face value, one might think the FDA would step in should clinics start providing such unproven biological therapies in Nevada and Utah, even if state laws in theory have greenlighted these clinical practices. Federal law preempts state law.
However, the FDA hasn’t done much of anything about unproven biologics in recent years including unproven stem cells.
I’m also not aware of any FDA action on SOT clinics in the U.S. or on clinics selling other emerging but still unproven biologics. Could SOT somehow be compliant with FDA regulations?
What’s next
The FDA’s recent inaction on unproven biologics leaves more space for additional states to pass laws allowing unproven and unapproved biologics. If the agency never challenges them, the state laws become more entrenched. The firms involved become bolder. More similar state laws may appear.
Such state laws could also lay a foundation for harmful federal laws on biologics or more federal court challenges to the FDA.
To be fair, I realize the FDA is in a tough spot at the moment with SCOTUS overturning Chevron and the agency’s appeal of a court loss over unproven stem cells still sitting unresolved at the 9th Circuit Court. The appeals court could even be swayed negatively by the extreme SCOTS Chevron ruling too leading to a negative outcome for the FDA. It’s got to be a stressful time within the CBER branch of the FDA that oversees biologics.
However, even in today’s difficult legal context, the FDA doing next to nothing about unapproved and scientifically/medically unproven biologics brings many risks for consumers and the agency itself.
For both Nevada and Utah, the FDA may have to wait for some firms there to violate federal regulations based on the new state laws before it can jump in to challenge the state laws.
The FDA is busy doing important work like posting warning letters to four companies marketing the unapproved animal drug toltrazuril to treat conditions like coccidiosis and equine protozoal myeloencephalitis (EPM) and approving phenylpropanolamine hydrochloride chewable tablets for the control of urinary incontinence due to a weakening of the muscles that control urination (urethral sphincter hypotonus) in dogs. Oh, and making sure people take their 10th mRNA COVID booster shot.