Under the Right to Try Act of 2017, terminally ill patients may access certain unapproved investigational drugs after which conditions are met?

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Access under the Right to Try Act is about giving a terminally ill patient a chance to try an investigational drug that hasn’t been approved yet, after certain safety steps have been shown in early human studies. The essential trigger is that the drug has completed a Phase I trial, which demonstrates initial safety in humans, and the patient provides written informed consent after being told the potential risks and the limited data on effectiveness. This pathway is intended for someone who has a life‑threatening condition and has exhausted all approved treatment options and cannot participate in a clinical trial. The drug does not need FDA approval at this point, and there’s no requirement to complete Phase II or to enroll in a randomized trial, which is why Phase I completion plus written informed consent is the defining condition.