And has provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physicianĪn eligible investigational drug is an investigational drug:. Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying). Been diagnosed with a life-threatening disease or condition. The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.Īn eligible patient is a patient who has: The agency is dedicated to these purposes, and it has been for more than three decades.īuilding on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, the FDA is providing information for patients on the Right to Try Act. FDA’s role in implementation of the Right to Try Act is largely focused on those obligations outlined in the law, which is limited to receipt and posting of certain information submitted regarding Right to Try use. This is the mission of our expanded access program. 
In addition to contributing to medical knowledge, some people participate in clinical trials because there is no treatment for their disease, treatments they tried have not worked, or they are not able to tolerate the current treatments.įor patients with serious or immediately life-threatening diseases or conditions, the FDA remains committed to enhancing access to promising investigational medicines for those unable to access investigational medical products through clinical trials. People may have many reasons for participating in clinical trials. This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved treatments.Ĭlinical trials provide information about whether a product is safe to use and can effectively treat or prevent a disease.
The Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, was signed into law May 30, 2018.
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