Testimony Before the Texas Senate Committee on Health and Human Services on Senate Bill 984 Regarding Access to Individualized Investigational Treatments
Heartland Impact
March 18, 2025
Chairwoman Kolkhorst, and Members of the Committee:
Thank you for holding a hearing on Senate Bill 984, legislation that would expand access to individualized investigational treatments for patients with life-threatening or severely debilitating illnesses.
I would like to thank Senator Bettencourt for introducing this legislation aimed at offering hope to people through the miracle of individualized medical care.
My name is Samantha Vick, and I am the Senior Manager for State Government Relations at Heartland Impact. Heartland Impact is the advocacy and outreach arm of The Heartland Institute. Both are independent, national, nonprofit organizations working to discover, develop, and promote free-market solutions to social and economic problems. Heartland specializes in providing state lawmakers the policy and advocacy resources to advance free-market policies towards broad-based economic prosperity.
The core principle in this legislation is the right of any patient to engage in additional medical treatments that may yield different results from what they have already attempted and what is currently approved by the United States Food and Drug Administration (FDA). Also known as the Right to Try.
Federal Right to Try legislation was signed into law on May 30, 2018. Right to Try is a compassionate policy allowing terminally ill and untreatable patients the right to try medicines that are deemed safe but have not yet gained final approval from the FDA. 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.
The federal Right to Try legislation was a significant win for health care policy and patients across the nation, however, it is very limited in scope. Senator Bettencourt has introduced this bill that picks up where Right to Try left off. SB 984 recognizes that advances in research offering individualized investigational treatments to patients just don’t work in the current FDA approval process, which was designed for one-size-fits-all drug approval.
The FDA’s mission is to protect the public by testing drugs to make sure they are safe and effective. The FDA develops and approves more drugs than any other country in the world. However, when previously approved treatments do not work for suffering patients, the FDA is simply too slow to respond. Patients who do not qualify for a clinical trial or are granted expanded access are left without hope and that is where Right to Try comes in.
This legislation takes the concept embedded in the federal Right to Try to the next step and offers hope to millions more Texans by expanding the option to those who have life-threatening or debilitating illnesses that could be helped through individualized investigational treatments.
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. Doctors and scientists can design a cancer drug or vaccine targeted toward a particular individual’s affected cells or particular genetic mutations, to stimulate the patient’s own body to fight cancerous tumors. Because that treatment is designed specifically for that patient, it cannot go through the FDA’s existing clinical trial system, which is designed to test treatments that work for hundreds or thousands of patients.
It’s idealistic to expect the FDA to respond as quickly as technological innovation demands. The FDA process was designed to be slow and deliberate to protect the greatest number of people by preventing them from being subjected to unproven drugs. However, that approval process was designed at a time when the human genome was not yet mapped and the idea of individualized DNA mapping was science fiction. Senate Bill 984 provides the flexibility to offer suffering patients a way forward.
Individualized treatment shows great promise. 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 diseases alike. For instance, researchers at Mayo diagnosed 13-year-old Araeya Sell with a rare genetic disorder that had gone undiagnosed for seven years. Through individualized investigational treatments, the Mayo Clinic designed a clinical trial therapy just for her, and thankfully she responded very well to their targeted therapies.
As research and technology progresses, more patients will benefit from individualized treatment programs. Thankfully, Texas is driving this noble effort by introducing legislation like Senate Bill 984.
Thank you for your time and consideration.
