Enacts the "right to try act" which grants access to terminally ill patients to investigational drugs, biological products and devices which may help the patients' conditions

1 Co-sponsor

• Kathleen A. Marchione

BILL NUMBER:S4716

Title of bill

An act to amend the public health law, in relation to enacting the "right to try act"

Purpose

Enacts the "right to try act" to provide terminally ill patients access to investigational drugs and products which may help the patients' condition.

Summary of provisions

Section one adds a new Article 40-a to the Public Health Law to provide access to treatments for terminally ill patients. This article details the legislative intent, defines eligible patients and investigational drugs, and provides for the availability of investigational drugs, biological products and devices. The article authorizes, but does not require, a manufacturer to make available an investigational drug, biological product or device to an eligible patient either without compensation or paid for by the eligible patient. While health plans may provide coverage of investigational drugs, the act expressly provides that they are not required to do so and the health plan, with certain exceptions may deny coverage when the patient begins use of the investigational drug or biological product or device.

Should the eligible patient die during the course of treatment by an investigational drug or biological product or device, the patient's estate is not liable for any outstanding medical debt. The article also provides health care provider protections from professional misconduct based solely on the provider's recommendation to an eligible patient regarding access to or treatment by an investigational drug, so long as the recommendation is consistent with medical standards of care. The act also expressly provides that it shall not be deemed to create a private cause of action against a manufacturer or any other person involved in the care of the eligible patient provided the terms of this section where complied with in good faith with reasonable care.

Section two provides that this act shall take effect immediately.

Justification

The federal Food and Drug Administration (FDA) mandates that medications go through a rigorous three-stage investigation before doctors can prescribe. While such process can often be critical in ensuring product safety, this lengthy process has the consequence of prohibiting terminally ill patients from accessing their last viable treatment option. The FDA does have a compassionate use program which permits the FDA to grant access to unapproved therapies to people with exceptional need; however, this process is similarly criticized as being bureaucratic and lengthy. For patients suffering from terminal illness, the length of this process can mean the difference between life and death.

Congress has recently begun looking at the FDA's process, and ways in which it may be improved. In the meantime, many states have begun to take action to ensure patients with no other options available have access to treatments which may save their lives. This legislation, modeled after a similar law passed in Colorado, permits terminally ill patients who have exhausted other treatment options to access drugs, products and devices that have completed phase one of a clinical trial but have not yet been approved for general use by the FDA. Laws such as this have now been enacted in five states and another fifteen states have similar legislation pending. The law is clear that it neither requires manufacturers to provide treatment, nor requires insurer to cover the treatment, it merely provides patients in dire circumstances another option or avenue to seek treatment by.

Legislative history

New bill.

Fiscal implications

None.

Effective date

Immediately.