Experimental Drug Access for Terminally-Ill Patients: A Review of the Right to Try Act

Early access to drugs that have not won approval from the United States Food and Drug Administration (FDA) is a heavily debated topic across academics and subject matter experts in the United States, especially regarding use for terminally-ill patients. The debates surrounding whether it should be legal, what restrictions should be put in place, and what freedoms or rights individuals are entitled to continue to raise ethical questions and concerns about policy implementation. The Right to Try Act, signed into law in 2018, is a policy that effectively removes the necessity of FDA approval, granting terminally-ill patients access to non-FDA-approved drugs. This thesis explores the historical examples that underpin the Right to Try Act, the ethical considerations associated with its promulgation, and policy recommendations to improve the current system for accessing experimental drugs. For numerous reasons addressed throughout this paper, granting physicians and pharmaceutical companies sole control of non-FDA approved drugs yields too much risk to the patient and opens these entities to greater liability. The Right to Try Act causes safety concerns and removes supervision over access to under-researched therapeutics. The best system—one that prioritizes patients and their autonomy, manages safety risks of non-FDA approved drugs, and mitigates the potential for unethical practices—requires federal oversight. To build this type of system, the FDA should retain the authority to protect medical ethics and the integrity of the medical establishment.