Crisco hails Senate passage of 'Right to Try' bill for terminally ill

HARTFORD - Terminally ill patients could try experimental medications and procedures not yet approved by the federal Food and Drug Administration as a last resort at life under a bill approved Tuesday on a bipartisan and unanimous vote by state Sen. Joseph J. Crisco, Jr., D-Woodbridge, and the entire state Senate.

 

State Sen. Joseph J. Crisco

Senate Bill 371 allows certain terminally ill patients, under specified conditions, to access medications and devices not approved for general use by the FDA. 

The bill applies to investigational drugs, biological products, or devices that have completed Phase 1 of an FDA-approved clinical trial and are still part of the trial.

To qualify for the program, patients must meet certain eligibility criteria and complete a detailed informed consent form.

Twenty-six U.S. states already have such laws on their books.

“This bill is about giving someone hope at a time when there is little hope left,” Crisco said. “Cutting-edge medical research, like the kind that goes on in Connecticut all the time, holds the promise of extended life or an improved quality of life for certain terminally ill people. If the patient, their doctor, the manufacturer, and the insurance company agree, they can try one of these experimental treatments.”  

The bill passed the Senate and was awaiting action in the House of Representatives late Tuesday. If passed by the House and signed into law, the bill would take effect Oct. 1, 2016.

The bill allows investigational drug manufacturers to provide eligible patients with investigational drugs. 

Manufacturers can charge eligible patients for the investigational drugs, and the bill allows insurance companies to cover investigational drugs, but does not mandate it.

To be eligible to receive treatment with an investigational drug, a patient must:

• have a terminal illness verified by his or her treating physician
• not be a hospital inpatient
• have considered all other FDA-approved treatment options
• be unable to participate in a clinical trial within 100 miles of his or her home
• receive a recommendation for the drug from his or her treating physician

This is a press release from Crisco's office.