Navigating Right to Try Requests: Institutional Considerations and Approaches

• June 01, 2020

• Hillary Noll Kalay , University of California
• Kate Gallin Heffernan , Epstein Becker & Green, P.C.
• Marylana Saadeh Helou , Verrill Dana LLP , Boston, MA
• Drew Douglas-Steele , Verrill Dana, LLP

Abstract

The federal right to try law provides an alternative pathway for patients to seek access to investigational drugs without FDA approval and IRB oversight. Proponents have argued that removing oversight barriers will improve the speed with which seriously ill patients can access treatment. Opponents argue that the law offers patients false hope and increases risks. Since the law’s enactment, very few patients have utilized this new pathway beyond what already existed through the FDA’s Expanded Access Drug Program. Institutions face several dilemmas when deciding how to address patient requests under the new law. An express prohibition could conflict with an institution’s intent to preserve the autonomy of the provider-patient relationship, while express permission could be viewed as endorsement of a pathway that weakens the FDA’s authority and ability to better inform safety and efficacy decision-making. In between the two opposing positions lies the option of allowing physicians and patients to utilize the right to try pathway with thoughtful consideration of institutions’ principles. To pursue this option, institutions should create policies and procedures for right to try requests by involving a diversity of stakeholders to reflect institutions’ roles both as research institutions and health care providers, and by drawing upon their experiences with and existing processes on expanded access. In doing so, institutions may also learn how they can improve upon their existing processes and policies applicable to Expanded Access, therefore furthering their missions of expanding access to and improving patient care.

ARTICLE TAGS

• Life Sciences