Senate healthcare committee discusses new version of ‘Right to Try’ bill

During Wednesday’s Senate Health Care Committee meeting, the committee discussed and reported favorably on SB 871, or “Right to Try Individualized Treatments.” The legislation would allow some patients who are suffering from life-threatening or severely debilitating illnesses to seek an “investigational drug, biological product, or device for treatment.”

Introduced by Sen. Benton Sawrey, R-Johnston on May 2, the bill enjoys bipartisan support with sponsorship by Sen. Gale Adcock, D-Wake, as well.   

“It allows patients under certain circumstances when they are terminal and there’s no other options or courses and there are no other treatments, after they’ve exhausted all options, to go seek individualized genetic treatments for their specific disease or condition,” said Sawrey, during the committee meeting. “I’m aware of no opposition. We have talked to the academic medical research centers about it. We have discussed this with some various people in industries and patient rights groups are very excited about this legislation. I think it’s a nice dovetail as to what we have in current law and will let North Carolina continue to be a leader in healthcare and healthcare sciences.”

During committee discussion Sawrey field questions about insurance coverage mandates for such healthcare. Sawrey and Sen. Kevin Corbin, R-Cherokee, clarified that the bill would not mandate that insurance companies pay for the treatments.

“I’m the biggest advocate for medical care, and having worked with sickle cell, I understand the importance of stem cells and all of those other things,” said Sen. Gladys Robinson, D-Guilford. “But the question I have for you is how does this differ from the patient’s right to request or get access to any medical treatment? And secondly, does this bill mean that insurance companies will support that treatment?”

“There’s no mandate generally for Medicare, Medicaid, or insurance companies to pay for a treatment that has not been authorized by the FDA,” explained Sawrey. “Just to be clear on that. These are treatments that they’re still in research and experimental phases. So, they have not gone through some of the necessary trials.”

Sawrey gave the example of a medication to treat a rare brain disorder that’s been approved in Europe since 2020; but not in the United States. American patients are currently leaving to go to Europe to receive that genetic treatment.

“What this bill would potentially allow them to do is to receive that medication in the United States before the FDA approval process is going forward,” he explained. “So, it’s focused on individualized genetic treatments, which is the expansion of the current ‘Right to Try’ bill, which is for investigational drugs, the general category, and the classification of medications.”

Sawrey also spoke to safety concerns, pointing out European trials are sometimes more advanced than FDA trials. 

“Keep in mind that oftentimes FDA trials require hundreds, if not thousands, of different patients to show outcomes and processes, years-long processes,” he said. “These are treatments that are uniquely tailored to one person or to one very distinct group of people so that the process is currently in place is more difficult, more arduous than what we see with general investigational drugs.” 

Sen. Julie Mayfield, D-Buncombe, echoed her support for the bill.

“We need this bill because right now physicians either can’t or won’t engage in this, and medical facilities can’t or won’t – for liability and other reasons – and maybe it’s not authorized by DHHS,” Mayfield said. “So, we’re just basically saying even though these treatments are not approved, legal, all of that here, we’re still saying we can do it.”  

The bill sponsor also fielded questions on how easily accessible the unapproved drugs or treatments will be.

“There’s a very rigid process you have to go through, and you can’t walk in with a rare condition and say, ‘Doctor, I want drugs one, two, and three.’ You have to exhaust all options,” explained Sawrey. “You have to have given very rigid informed consent you have to go to a very certain type of facility to receive it. I mean, it’s not an easy process to get through necessarily. It’s very controlled, but at the same time, it opens up options to patients for the specific individualized genetic treatments which are going to become the medications in the future. I think that’s where medical research is going in 2024 and going forward is that we’re seeing more genetic therapies that are targeted to treat these rare diseases.”

This bill was reported favorably by the committee and referred to the Senate Judiciary Committee. 

Across the legislative building, a companion bill in the North Carolina House, HB 1029, also enjoys bipartisan support. The primary sponsors in the House are Rep. Allen Chesser, R-Nash, Rep. Hugh Blackwell, R-Burke, Rep. Larry Potts, R-Davidson, and Rep. Timothy Reeder, R-Pitt.

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