This bill expands the federal "Right to Try" law to allow patients with life-threatening diseases or severely debilitating illnesses to access investigational individualized medical treatments customized to their genetic profile, even if those treatments have not completed FDA approval. Eligible patients must have exhausted or considered approved treatment options and obtain written informed consent from a physician who is in good standing and not compensated by the treatment manufacturer. The bill permits manufacturers of these personalized treatments to decide whether to make them available and requires that treatments be administered at health care facilities that comply with federal human subject protection standards. No specific funding or implementation timeline is included in the legislation. The amendment modifies existing federal drug law to add these individualized treatments alongside the current Right to Try protections for experimental drugs.
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