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Goldwater Institute urges Kentucky to consider 'Right to Try 2.0' for individualized treatments
Summary
Goldwater Institute presenters recommended state action to create a pathway for individualized investigational treatments (gene/cell therapies) for patients with life‑threatening conditions, arguing existing regulatory pathways were built for mass‑produced medicines and that state action can protect patient choice while preserving safeguards.
Representatives from the Goldwater Institute asked the interim joint committee on health services to study and consider legislation that would expand Right to Try access for individualized investigational therapies, such as bespoke gene or cell treatments developed for single patients.
Michael Frazer and Naomi Lopez described cases in which families sought individualized therapies that did not fit the traditional clinical‑trial model. Lopez recounted the Riley family, which sought an individualized gene therapy for a child and traveled overseas to obtain it. "No American family should have to leave this country to pursue a potentially life saving treatment designed for their child," Lopez said.
Presenters emphasized the proposal would preserve physician oversight, informed consent and institutional review; the state model would create a pathway for individualized treatments that have not gone through large clinical trials. Committee members questioned who would pay for such treatments and expressed equity concerns; Lopez and colleagues said the law would not compel insurers to pay but that some payers have in prior right‑to‑try cases, and they pointed to institutional review board (IRB) protections and federal guidance as safeguards.
Members asked for additional information about payment, liability and equity; presenters offered to provide legislative language and models used in other states.
Provenance: Based on the Goldwater Institute presentation and the committee’s Q&A.
