Thank you, Mr. Chairman and members. 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 Rep Haugaard for bringing this piece of legislation forward. President Trump signed federal Right to Try Legislation on May 30th 2018. Right to Try is a common sense bill that recognizes that people who have perhaps months to live, can not wait additional years for the FDA to complete phases of trials on a drug that they have already found to be safe. South Dakota passed Right to Try and became the 8th state in the country to do so. Rep Leslie Hinemann carried the bill here in the South Dakota House. The FDA is responding, slowly to reform. This bill begins the next steps in reform by recognizing that waiting until a patient is at death’s door is too late.
FDA is a bureaucracy that protects the safety of the public by testing food and drugs to make sure that they are safe, and that drugs are 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 only approves around 1,000 cases/year.
Right to Try legislation provided hope to many more Americans who couldn’t afford to wait in that line. What if your son or daughter was told that there was nothing more to be done but wait, and pray for a cure to an insidious debilitating disease? What if you knew a medical breakthrough was found to be safe, but had not yet been approved through the years long clinical trials and legal battles? If you knew that a lifetime of disability, disease progression and suffering could be replaced with a cure, or helped with a treatment, you would likely assume some risk for that hope, or at the very least want that option.
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 face debilitating disease and the possibility that the progression will lead to death before a treatment is approved.
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. At the Mayo Clinic, chemotherapies are being developed to match the unique genetic characteristics of a single cancer in a single person. 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.
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 [email protected] or 312/377-4000.
2015 Right to Try Passed in South Dakota making it the 8th state in the US to do so.
Right to try story
The FDA does offer expanded access to investigational drugs through EAP
The US Food and Drug Administration’s Fact Sheet on Right to Try:
Goldwater Institute’s Right to Try Homepage, offering information on the Institute’s years of work to pass Right to Try:
Right to Try2.0 the next step in hope for suffering patients
FDA at a glance
Mayo Clinic Beauty Project for Individualized medicine