When you or a family member is diagnosed with a serious or life-threatening disease, you have choices to make about your treatment once standard treatment options are exhausted. Two important options are clinical trials and expanded access to experimental products, although historically these options have been extremely difficult to tap into because of federal regulations. The good news is that on May 29th, 2018, new federal legislation went into effect creating an alternative pathway for patients to obtain access to investigational products outside of a clinical trial. The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 allows patients with life-threatening diseases or conditions to pursue access to investigational drugs or biologics that are not approved, are in the clinical trial approval process, and have completed the phase 1 clinical trial process.
To learn more about the parameters in the legislation allowing for clinical trial and experimental product use, please read POINTS FOR PATIENTS TO CONSIDER: Clinical Trials and/or Expanded Access to Experimental Drugs or Devices (Single Patient INDs or IDEs).