VETO GM1146, SB2181 SD2 HD2, 4/29/16

News Release from Office of the Governor, April 29, 2016

RELATING TO ACCESS TO TREATMENT FOR TERMINALLY ILL PATIENTS.

Permits manufacturers of investigational drugs or biological products beginning on January 1, 2017 to make these drugs and products available to terminally ill patients under certain conditions.

Message: Veto GM1146

STATEMENT OF OBJECTIONS TO SENATE BILL NO. 2181

Honorable Members Twenty-Eighth Legislature State of Hawai’i

Pursuant to Section 16 of Article 111 of the Constitution of the State of Hawaii, I am returning herewith, without my approval, Senate Bill No. 2181, entitled “A Bill for an Act Relating to Access to Treatment for Terminally 111 Patients.”

The purpose of this bill is to enable terminally ill patients in Hawai‘i to obtain from manufacturers investigational drugs and biological products that have not yet been approved by the United States Food and Drug Administration (FDA) for general use. This bill also shields practitioners who recommend investigational drugs to their patients from liability and the heirs of patients who receive investigational drugs from claims of responsibility for the costs of those drugs in the event of the patient‘s death.

This bill is objectionable because the FDA’s existing “expanded access program” (also known as the “compassionate use program”), which this measure seeks to circumvent, already serves to increase access to investigational drugs for patients under the care of a physician while preserving the approval process, treatment data reporting, and other patient-centered safeguards. The regulations associated with this program were amended in 2009 and should be allowed a chance to be fully implemented and further publicized. While admirably seeking to increase access to potentially life-saving drugs, this measure unreasonably compromises the consumer protections provided by the FDA’s expanded access program. The federal system of regulations that govern the sale and distribution of new and investigational drugs is also instrumental in the development of beneficial drug products. Interference with that system will likely have the unintended consequence of delaying development of those potentially life-saving drugs. Additionally, this measure unreasonably intrudes upon a system of federal law in violation of the Supremacy Clause. Since the sale and distribution of new and investigational drugs will remain federally regulated whether or not this measure becomes law, it is also unclear what actual benefits would accrue to patients in Hawai'i.

For the foregoing reasons, I am returning Senate Bill No. 2181 without my approval.

Respectfully,

DAVID IGE

Governor of Hawaii

Text, Status: SB2181 SD2 HD2

CB: Ige Vetoes Experimental Drug Bill