North Carolina House Health panel OKs ‘Right to try’ for terminal patients

When all else fails to provide relief, patients suffering from life-threatening or debilitating illness in North Carolina could soon have access to individualized investigational drugs tailored to attack specific diseases within their bodies. 

The House Health Committee is set to take up House Bill 1029 – identical to Senate Bill 871 – which would grant patients with life-threatening or “severely debilitating illnesses the right to try individualized investigational drugs, biological products and devices.” It also would provide $50,000 for the Department of Health and Human Services to implement the law. 

The proposed legislation builds on a 2015 law that mirrors the federal Right to Try Act, which gives patients who have exhausted all other mainstream treatment options access to experimental drugs and procedures. Certain terminally ill patients in North Carolina already have access to experimental drugs. Others suffering “severe chronic diseases” also can undergo experimental adult stem cell therapies, according to a summary of the Senate bill. 

The House Health Committee greenlit the proposal on Tuesday morning. The Senate Judiciary Committee is set to consider its version of the bill on Wednesday at 2 p.m.

Eligible patients are defined in the legislation as having a serious illness diagnosed by a physician who has considered other Food and Drug Administration-approved treatment options and has a doctor’s recommendation of individualized experimental treatment. 

Before undergoing experimental treatment, the patient or a guardian would be required to provide informed consent. 

State Rep. Allen Chesser, a Republican representing Nash County and a primary sponsor of the House bill, last week said that advances in medical science are occurring faster than federal authorities can approve them for use. Drugs and other medical products tailored to attack a patient’s unique ailment or work with their individual genetic makeup show promise in tackling some of the hardest-to-treat diseases, he said. The updated version of the bill that passed the House Health committee specified that Medicaid is not forced to pay for individualized experimental treatments, Chesser said on Tuesday.

But many patients who could benefit from such treatments can’t afford to wait out lengthy clinical trials required for FDA approval, if such studies were even feasible for individualized treatments. 

FDA approval calls for trials with thousands of patients taking the same medications for specific diseases. Often it is not possible to study individual effectiveness of drugs on rare or genetically unique illnesses, he said.

The legislation now under consideration would bypass those hurdles with a patient’s recognition of the risks and possible benefits of trying experimental treatments. Patients would have to waive the right to pursue damages against drug manufacturers or doctors involved in the treatment and licensing boards would not have the ability to punish medical professionals who participate in those treatments.

If passed by both chambers and signed by the Governor, the law would take effect on Oct. 1.

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