Monday, March 30, 2020

Monday, March 30, 2020

Right to Try legislation sits in North Carolina senate committee

North Carolina State Assembly   Wikipedia

North Carolina House Bill 934, which passed unanimously 114-0, was sent to the State Senate where it currently is in committee.

The bill takes North Carolina’s Right to Try law a step further.

According to an analysis of the bill provided by a state congressional lawyer, HB 934 would allow patients with chronic or terminal diseases to receive adult stem cell treatment that is in clinical trials on humans but has not yet been approved by the Food and Drug Administration.

The current law stipulates that individuals with terminal illnesses may receive treatment that includes investigational drugs, biological products, and devices.

“This bill was filed to help people with a chronic health condition who are in their last period of life and are looking for options for treatment that could very well help extend their life,” Rep. Donny Lambeth told the FDA Reporter.

Lambeth is one of four Republican cosponsors of the bill. In all, there were 21 cosponsors.

The analysis stipulates that treatment under the new bill has to meet the following criteria.

— It has to be administered by a licensed physician.

— It is overseen by a institutional review board.

— The treatment must take place at a hospital, ambulatory surgical center or a medical school.

The bill also stipulates rules for the institutional review boards.

The boards must be affiliated with accredited medical schools or licensed hospital. In addition, the board has to keep records of all patients who receive adult stem cell treatment and it also has to submit an annual report to the state medical board.

There also numerous regulations the board has to deal with.

“It would be a Class A1 misdemeanor to knowingly offer to buy, offer to sell, acquire, receive, sell, or otherwise transfer adult stem cells for valuable consideration. Reimbursement of expenses and usual medical fees would not be unlawful,” the analysis said.

“It would prohibit the Board from sanctioning physicians based on their recommendation that a patient have access to adult stem cell treatment. It would prohibit State officials from interfering with eligible patients' access to adult stem cell treatment. House Bill 934 would clarify that health insurance is not required to provide coverage for adult stem cell treatment.”

If the bill passes the Senate, the bill would become law on December 1 this year.

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North Carolina State Senate

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