House

Bill 481
2016 Freedom Index Score (+2)
Analyst: Matthew Keenan
Date: March 1, 2016

ANALYSTS NOTE: House Bill 481, known as the Right-To-Try Act, would establish a new chapter in Idaho
State Code concerning terminally ill patients and their access to investigational treatments. This bill
would only affect patients who seek to use investigational drugs or treatments still in clinical trials under
the supervision of the FDA. As of now, the FDA must approve any investigational treatments, drugs, and
devices before they are sold or used in the United States. HB 481 would provide a potential means for
terminal patients, under the supervision of a physician or doctor, to voluntarily access investigational
treatments, drugs or devices from a manufacturer. The legislation does not obligate a manufacturer to
provide investigational treatments, drugs or devices to a terminal patient. The Right-To-Try Act would not
require a health plan, third-party administrator or government agencyto provide coverage for the cost
of an investigational treatment, biological product or device.

Point No. 1: Does it create, expand, or enlarge any agency, board, program, function, or activity of
government? Conversely, does it eliminate or curtail the size or scope of government?

ANALYSIS: As written, House Bill 481 prohibits any licensing board or disciplinary body from
revoking or suspending a providers license when (and if) they were to provide an investigational
drug, treatment or device to a terminal patient. HB 481 also places limits on state officials ability
to restrict an eligible patients access to investigational drugs, treatments or devices. (+1)

Point No. 12: 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?

ANALYSIS: In practice, House Bill 481 would provide an alternative path to investigational
treatments (currently in FDA clinical trials) for Idaho residents. Investigational drugs, treatments
and devices would still be required to go through the FDA clinical trial process; however, patients
deemed terminal would have the option to seek potentially life-saving treatments directly
through a provider or manufacturer. The legislation does not override the FDAs process for
ensuring the safety of investigational treatments, rather it expands the ability of Idaho residents
to exercise their treatment options, locally, with their doctor. This bill, in practice, would cede
some control back to terminal patients within the state by allowing them to seek investigational
treatments that have passed phase one of clinical trials and are ongoing in the clinical trials
process. (+1)