The Goldwater Institute's Brian Norman on "Right to Try 2.0" and the Fight for Individualized Treatments

On this episode of the Health Policy Podcast, Brian Hyde speaks with Brian Norman, Director of State Affairs at the Goldwater Institute, about the push to expand "Right to Try" laws to include individualized and gene-based treatments. Norman explains how the original Right to Try movement, signed into federal law in 2018, allowed terminally ill patients to access investigational drugs that had passed Phase I FDA safety trials. Now, Goldwater is advancing "Right to Try 2.0," aimed at creating a clearer regulatory pathway for patients with rare and ultra-rare diseases to access personalized treatments such as gene and immunotherapies. Norman argues that the FDA's traditional approval process—designed for mass-market drugs—can take a decade and cost more than $1 billion, making it impractical for treatments serving small patient populations  The conversation highlights the story of an Arizona family forced to relocate to Italy during the COVID-19 pandemic so their young daughter could receive an individualized gene therapy unavailable in the United States. Norman outlines the safeguards built into the proposal, addresses concerns from medical ethicists about patient safety and "false hope," and explains how Goldwater works at the state and federal levels to reduce regulatory barriers and expand patient choice. The episode explores the tension between innovation and oversight—and asks whether patients facing life-threatening conditions should have greater freedom to pursue promising, personalized care.