Pharmaceutical companies face new compliance and reporting requirements after recently passed federal legislation in the US means eligible patients can apply to access drugs that have completed phase one clinical trials and are the subject of an active Food and Drug Administration (FDA) application. The Right to Try Act lets eligible patients, through drugmakers, seek access to treatments not yet approved by the FDA if they are likely to die within the coming months or face a significantly premature death from an illness or condition. Before the act, 38 states had laws that allowed patients to try experimental treatments.
Pharmaceutical companies face new compliance and reporting requirements after recently passed federal legislation in the US means eligible patients can apply to access drugs that have completed phase one clinical trials and are the subject of an active Food and Drug Administration (FDA) application. The Right to Try Act lets eligible patients, through drugmakers, seek access to treatments not yet approved by the FDA if they are likely to die within months or face a significantly premature death from an illness or condition. Before the act, 38 states had laws that allowed patients to try experimental treatments.