Dr. Holt is professor emeritus in the department of otolaryngology–head and neck surgery at the University of Texas Health Science Center in San Antonio.
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October 2018What Is the “Right to Try”?
Right-to-try laws are U.S. state and federal laws THAT give terminally ill patients the right to seek drug treatments and experimental therapies that remain in clinical trials and have completed Phase 1 of the Food and Drug Administration’s approval process but have not been fully approved by the FDA. While 41 states have passed Right to Try laws, President Trump signed a federal bill into law in May 2018.
Who Qualifies?
To be eligible, a patient must meet the following conditions:
- Be diagnosed with a life-threatening disease or condition;
- Have exhausted approved treatment options;
- Be unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician; and
- Give written informed consent regarding the risks associated with taking the investigational treatment.
What Is a Life-Threatening Disease or Condition?
Federal law defines a life-threatening disease or condition as: “Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.”
What Drugs or Treatments Qualify?
The treatments available under the law must meet the following conditions:
- Have completed an FDA-approved Phase 1 clinical trial;
- Be in an active clinical trial intended to form the basis of an application for approval or be the subject of an application for approval that has been filed with the FDA; and
- Be in ongoing active development or production and not discontinued by the manufacturer or placed on clinical hold.