Testimony Before the Iowa House Health and Human Services Committee on House File 320 Regarding Right to Try for Individualized Treatments
Heartland Impact
March 2, 2025
Chairman Nordman, and Members of the Committee:
Thank you for holding a hearing on House File 320, legislation that would expand access to individualized drugs and therapies that have not yet been completely approved by the FDA but could help patients who have no other options.
I would like to thank Rep. Steve Bradley 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.
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. State legislatures led this fight in a bipartisan effort.
Now, the states are leading again. Rep. Bradley has introduced this bill that picks up where Right to Try left off. HF 320 recognizes that advances in research offering individualized 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 is a bureau set up to protect the public by testing drugs to make sure they are safe and effective. The FDA has done a good job in our country, which develops and approves more drugs than any other country in the world. The FDA regulates more than 21 cents out of every dollar spent by the American consumer, including more than 23,000 prescription drugs and 77 percent of the nation’s food supply.
Unfortunately, when approved treatments do not work for suffering patients, the FDA is simply too slow to respond. Those not included in a clinical trial or granted expanded access are left without hope.
Right to Try offers 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 option to those who have life-threatening or debilitating illnesses that 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. 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 unrealistic 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. Right to Try 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 Araeya Sell with a rare genetic disorder that had gone undiagnosed for seven years. Fortunately, the 13-year-old responded 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 benefit from individualized treatment programs. Thankfully, Iowa is driving this noble effort by introducing legislation like House File 320.
Thank you.
