Federal Right to Try: Where Is It Going?

Policy-makers, bioethicists, and patient advocates have been engaged in a fierce battle about the merits and potential harms of a federal right-to-try law. This debate about access to investigational medical products has raised profound questions about the limits of patient autonomy, appropriate government regulation, medical paternalism, and political rhetoric. For example, do patients have a right to access investigational therapies, as the right-to-try movement asserts? What is government's proper role in regulating and facilitating access to drugs that are still in development? In this review, we analyze the history of the right-to-try movement, review the arguments put forth by supporters and opponents of the legislation, and consider the movement's consequences. Two possible scenarios may emerge. One is that the right-to-try pathway may fail to meaningfully increase patient access to investigational products. Alternatively, certain companies may attempt to rely on the federal right-to-try legislation to sell investigational products, taking advantage of the provision that allows for direct costs, as there is currently no clear mechanism for enforcement or monitoring of cost calculations.