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Senate Bill 1346 — Gene therapy products, moratorium (0)

Bill Description: Senate Bill 1346 would prohibit human gene therapy products from being administered to children or pregnant women.

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NOTE: Senate Bill 1346 is related to Senate Bill 1036 (2026), but Senate Bill 1346 is narrower in scope.

Does it violate the principles of federalism by increasing federal authority, yielding to federal blandishments, or incorporating changeable federal laws into Idaho statutes or rules? Examples include citing federal code without noting as it is written on a certain date, using state resources to enforce federal law, and refusing to support and uphold the tenth amendment. Conversely, does it restore or uphold the principles of federalism?

Senate Bill 1346 would create Section 39-4810, Idaho Code, to institute “a moratorium on the administration of human gene therapy products in certain cases.”

Specifically, it would say, “No person in Idaho shall administer, by any route or modality, any human gene therapy product for any infectious disease indication to a child under eighteen (18) years of age or a woman who is pregnant, regardless of whether such administration is termed an immunization, vaccine, or any other term.”

The bill would define “human gene therapy product” as “all products that mediate their effects by transcription or translation of transferred genetic material or by specifically altering human genetic sequences.” It would provide a non-exhaustive list of examples, including “nucleic acids, such as plasmids and in vitro-transcribed ribonucleic acid; genetically modified microorganisms, such as viruses, bacteria, and fungi; engineered site-specific nucleases used for human genome editing; and ex vivo genetically modified human cells.”

The bill would be effective immediately upon passage, and the moratorium would “remain in effect for two (2) years after the effective date of this section, subject to legislative review of available safety data.”

The bill’s prohibition would not apply to “human gene therapy products utilized for treatment or therapy of cancer or genetic disorders.”

It appears that the bill is meant to prohibit the use of RNA vaccines (like the COVID-19 vaccine), but it could potentially prohibit other products as well. To counter this issue, the bill says, “An individual human gene therapy product may be exempted from the provisions of this section if the legislature determines, after reviewing the available safety data for such individual human gene therapy product, that the available safety data indicates that the product has been proven safe; proper informed consent procedures exist for the administration of the product; and compensation for an individual who experiences an adverse outcome from the product has been assured by the manufacturer or person who administers the product.”

The legislature could also exempt a human gene therapy product if it “is part of a clinical trial that is covered under an active institutional review board protocol” or it “is provided under expanded access, also known as compassionate use, for a patient with a serious or immediately life-threatening disease or condition.”

While this bill is narrower in scope than last year’s version, and it applies only to minors and pregnant women, it still attempts to impose government’s determinations about what medical treatments are safe and acceptable in place of individual choice. This is not unprecedented, of course, as the FDA already does this. While there are many lenses through which one can view this bill, one is that it is the Idaho Legislature rejecting a questionable endorsement by the FDA of an unproven medical technology. 

While there is room to debate the appropriateness of the FDA’s processes (and even its existence), there is value in the Legislature taking initiative and not just rubberstamping whatever claims come out of federal agencies. 

Perhaps in the future, we will see the state take a similar stand to increase individual freedom and choice rather than to restrict it. 

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