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Testimony Before The Arizona Senate Health and Human Services Committee on Senate Bill 1163 Regarding Right to Try

March 14, 2022

Matt Dean Testifies Before The Arizona Senate Health and Human Services Committee Regarding Right to Try

My name is Matt Dean. I am a Senior Policy Fellow for healthcare outreach at the Heartland Institute. Heartland is a 37-year-old, nonpartisan, nonprofit research and advocacy group that develops and promotes free market solutions based on our constitutionally protected freedoms.

I would like to thank Sen Barto for introducing this legislation aimed at offering hope to people through the miracle of individualized medical care.

Federal Right-to-Try legislation was signed into law on May 30th, 2018. Right-to-Try is a compassionate idea that is rooted in the cold-hard fact that people who have perhaps months to live, cannot wait additional years for the FDA to complete phases of trials on a drug that they have already found to be safe. State legislatures led this fight in a bipartisan effort.

Now the states are leading again. Senator Barto has introduced this bill that picks up where Right-to-Try left off. SB1163 recognizes that advances in research offering individualized treatments to patients just doesn’t work in the current FDA approval process that was designed for one-size-fits-all drug approval.

FDA is a bureau set up to protect the safety of the public by testing drugs to make sure that they are safe and effective. The FDA has done a good job in our country that develops and approves more drugs than any other country in the world. The FDA regulates 20 cents out of every dollar spent by the American consumer including 20,000 prescription drugs and 78% of the food supply.  

However, when approved treatments do not work for suffering patients, FDA is simply too slow to respond. The current emergency expanded authorization approval process was only approving around 1,000 cases/year. Those not included in a clinical trial or expanded access, are left without hope.

Right to Try has offered that hope for those who face a life-threatening disease, have exhausted all treatments and do not qualify for a clinical trial. This bill takes the next step and offers hope to millions more by expanding the available patients to those who could be helped through individualized treatments. So, what has to change?

The FDA by its nature amasses very large cohorts and looks for cures and treatments that are safe for all. However, as research continues to accelerate, new treatments and potential cures are being found for smaller cohorts.

Its unrealistic to expect the FDA to respond as quickly as technological innovation demands, but Right to Try has offered the flexibility to offer suffering patients a way forward. The FDA was intended to be so to protect the greatest number of people by protecting them from unproven drugs. However, that approval process was designed at a time when the human genome was not yet mapped, and the idea of individual DNA mapping was science fiction.

The Mayo Clinic’s “All of Us” research initiative aims at building a bank of one million deidentified genetic profiles. This will allow researchers to design patient-specific therapies to cure and treat common and rare disease. Researchers at Mayo recently diagnosed Araea Sell with a rare genetic disorder that had gone undiagnosed for seven years. The thirteen-year-old is responding to therapy designed for just her thanks to targeted treatment through a clinical trial through Mayo. "I'm very thankful and I feel much better," says Araeya, who loves camping, crafts and hanging out with friends. "I have a lot more energy, and I'm not so tired all the time."

As research builds, more patients will have the opportunity to have the chance that Araeya has. States are shaping that with important legislation like this.

Thank you.

Nothing in this testimony is intended to influence the passage of legislation, and it does not necessarily represent the views of The Heartland Institute. For further information on this and other topics, The Heartland Institute’s website provides a great link to many policy resources.

The Heartland Institute can send an expert to your state to testify or brief your caucus; host an event in your state, or send you further information on a topic. Please don’t hesitate to contact us if we can be of assistance! If you have any questions or comments, contact Heartland’s government relations department, at governmentrelations@heartland.org or 312/377-4000.

Article Tags
Health Care
Author
Matt Dean is Senior Fellow for Health Care Policy Outreach at The Heartland Institute.
mdean@heartland.org