Marianne Spencer · Mar. 2018
86 Geo. Wash. L. Rev. Arguendo 30
In the past four years, thirty-eight states have passed legislation creating a right for terminal patients to try investigational drugs without approval by the Food and Drug Administration. Despite the popularity of the laws, this legislation has functioned as a legal placebo because manufacturers are hesitant to distribute treatments under the authority of these laws due to concerns about liability, cost, and other administrative burdens. A solution is pending in Congress, but even if it is passed it is unlikely that the federal bill, as written, would actually facilitate access to these treatments.
This Note proposes a federal approach to solve the problems individuals with terminal illnesses face when seeking investigational drugs. This Note proposes that Congress (1) pass a federal right-to-try law to eradicate preemption concerns and (2) add language to the law to incentivize manufacturers to provide the drugs to those with terminal illnesses. This approach would go beyond providing terminal patients a nominal right to try by instituting pragmatic procedures that make it easier for patients to access potentially lifesaving treatments.