Idaho would pause certain gene therapies for children and pregnant women

People in Idaho would be barred from giving covered gene therapy products for infectious diseases to children under 18 or pregnant women. The restriction would cover anyone giving these products in Idaho. Covered products work through transferred genetic instructions or specifically change human genetic sequences. The restriction would apply however the product is given, including when it is called a vaccine. Products used to treat cancer or genetic disorders would be excluded. Lawmakers could approve exemptions for individual products. If passed and approved, the bill would take effect immediately. The pause would last two years from that date, subject to lawmakers’ review of available safety data.

Lawmakers could exempt an individual product after reviewing its available safety data and finding that it meets one of three routes. Each exemption would cover an individual product under the pause. One route would require evidence proving the product safe, proper informed consent procedures, and assured compensation for harmful outcomes from its manufacturer or provider. Informed consent means agreeing with an understanding of the risks. Another route would require the product to be part of a clinical trial with an active research oversight board protocol. The third route would require the product to be provided through compassionate use, which allows access for a patient with a serious or immediately life-threatening disease or condition.