This bill amends RSA 126-Z, renaming it as the Right to Try Act, and revises the eligibility criteria and definitions for terminal patients seeking access to investigational drugs, biologics, or devices. The bill replaces the term "biological products" with "biologics" throughout the text. It modifies the definition of an "eligible patient" to include those diagnosed with a life-threatening disease or condition, and clarifies that the patient must have already tried or be ineligible for FDA-approved treatment options, be unable to participate in a clinical trial, and provide written informed consent. Additionally, the bill specifies that physicians providing access to investigational therapies will not be compensated directly by the manufacturer.
The bill also introduces the definition of a "life-threatening disease" and outlines what constitutes "other protected access," including expanded access and off-label use. It states that manufacturers may provide investigational drugs, biologics, or devices to eligible patients, potentially requiring payment or participation in data collection, but insurers or state agencies are not required to cover the costs. The bill protects physicians and facilities from actions against their licenses based primarily on their involvement with investigational therapies. It also clarifies that there is no private cause of action against manufacturers or caregivers complying with the act in good faith. The act is set to take effect on January 1, 2025.
Statutes affected: Introduced: 126-Z:1, 126-Z:3