Bills to allow individualized investigational treatments for eligible patients and prohibit vaccine mandates in schools pass health committees

By

Soraya Marashi

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Several noteworthy bills were discussed in recent health committee meetings in the Arizona Legislature.

 

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Senate Bill (SB) 1163 was introduced at the Senate Health Committee meeting on Feb. 2. Sponsored by Sen. Nancy Barto (R – Phoenix), the bill would allow an eligible manufacturer, pursuant to all federal safety rules and guidelines, to develop an individualized investigational treatment for an eligible patient with a prescription from their physician. These investigational treatments would include individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines. Health plans could, but would not be required to, provide coverage for this treatment.

Christina Sandefur, executive vice president at the Goldwater Institute, testified in favor of the bill. She said the bill would expand on Arizona Terminal Patients’ Right to Try Referendum from 2014, which allows eligible patients to be treated with investigational drugs that have not yet been approved for general use by the FDA.

“Science and technology are not standing in the way of progress, old federal rules and red tape are. Medical innovation these days is quickly outpacing regulation that was put into place decades ago for very, very different medicines, and these life-saving medicines of the future are being blocked by regulations of the past,” said Sandefur. “The FDA’s approval process just wasn’t designed for individualized treatments. It was created for our typical one-size-fits-all medications. So, under that process, approval can take decades. That’s time that dying patients don’t have.”

A few legislators, namely Sen. Rosanna Gabaldon (D – Sahuarita), and Raquel Teran (D – Phoenix), brought up concerns with a lack of clarity in the bill and not enough information regarding what kind of patients would be eligible, and the manufacturing companies that would be developing the treatments. 

The bill ultimately passed (6-2) and moved on to the Senate Rules Committee.

In the House Health & Human Services Committee meeting on Monday, House Bill (HB) 2086 was introduced by Rep. Joanne Osborne (R – Goodyear), who chairs the committee. The bill would prohibit immunizations for COVID-19 from being added to the list of required immunizations for school attendance.

“As we move forward, we know the complications of the last two years that have occurred from COVID are weighing on our children, and the fear continues. It’s going to be potentially another 5 to 10 years for us to get through the aftermath that COVID has caused … we have got to stop fear from continuously being in our childrens’ minds,” said Osborne.

Two speakers testified against the bill, including Jeanie Castine, who stated: 

“This bill concerns me because it seems not to consider members of the population who may have compromised immune systems or underlying health conditions. All students and staff deserve to be safe in schools, and vaccine requirements exist to keep them safe and healthy.”

Will Humble, executive director of the Arizona Public Health Association, also spoke in opposition to the bill. He said the ultimate purpose of the vaccine requirement would be to have enough vaccinated children in the classroom to prevent outbreaks so that they don’t miss school because of the outbreaks. He also mentioned the emerging evidence that the Omicron variant has resulted in an increased likelihood of worse outcomes for children. 

Rep. Alma Hernandez (D – Tucson) noted that there already is a way for parents to opt out of vaccinating their children, through either religious or personal exemptions. However, Rep. Beverly Pingerelli (R – Peoria) pointed out her belief that the process of getting an exemption is often time consuming and complicated.

The bill ultimately passed in a 5-4 vote. Rep. Pamela Powers Hannley (D – Tucson), who voted against the bill, highlighted the fact that Arizona has one of the worst death rates in the country from COVID-19, and that it was necessary to take actions to protect communities.

“Many vaccines have been approved to prevent the spread of disease in schools. Allowing children and school staff to go to school unvaccinated will not dispel fear, it will increase fear and disease, it will increase rolling quarantines for students and staff, and that will decrease learning and increase hassles for parents who have to stay home with sick children. Personal choice in my opinion must be weighed with social responsibility. The legislature has the responsibility to protect public health.”

Rep. Steve Kaiser (R – Phoenix), who voted in favor of the bill, emphasized his support of a parent’s right to make the best decision for their children.

“I don’t need the government’s permission in an opt-out process to determine whether my kids are going to get vaccinated. It’s my decision as a parent.”