Assessment of the Right-to-Try Law

Abstract

On May 30, 2018, the Right-To-Try bill, allowing the use of experimental, non-Food and Drug Administration (FDA)-approved drugs as a last resort for those unable to participate in clinical testing who have also exhausted all other treatment options, was signed into law (1). At the time this bill was signed, 38 states had passed similar Right-To-Try laws; this law is nationwide (1). The requirements for granting approval of experimental drug treatment under Right-To-Try laws are: (1) a terminally ill patient has exhausted all other treatment options and is ineligible to participate in clinical trials, (2) the experimental drug passes FDA phase 1 clinical testing, (3) the patients’ health-care provider or treating physician must recommend and approve the experimental treatment, (4) the pharmaceutical manufacturer must approve the drug for use as an experimental treatment, and (5) patients’ written informed consent is required (2,3). Although certain experimental drugs may improve some patients’ conditions, adverse health effects or no health improvement are more likely

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