Pharma/Biotech Perspectives Track
2019 AER Conference
B10 - Right to Try—Legal, Ethical, and Implementation Issues
Holly Fernandez Lynch, JD, MA-Bioethics
John Russell Dickson, MD Presidential Assistant Professor; Assistant Faculty Director of Online Education, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania
Richard Klein
Director, Expanded Access Programs & Policy, GE2P2 Global
Christine MacCracken, BSN, MSHEd
Director, Patient Support, Janssen, Pharmaceutical Companies of Johnson & Johnson
Speaker(s)
On May 30, 2018, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act, offering a new pathway – distinct from FDA’s longstanding Expanded Access pathway – for patients to access investigational products outside of clinical trials. This session will explore the key attributes of both Expanded Access and Right to Try, including legal and ethical considerations. Participants will learn how industry is responding to Right to Try, as well as how to guide their own institution’s policy and practice regarding pre-approval access to investigational products. The session will also include a group discussion about whether and how both pathways have arisen and been addressed at their institutions, as well as the factors contributing to pathway selection. During this session, speakers and attendees will:
Learning Objectives:
- Describe and differentiate key tenets of Expanded Access and Right to Try
- Identify ethical considerations for investigational use outside of the clinical trial setting
- Understand key industry perspectives on pre-approval access
- Review the patient protections afforded by each pathway and the role of the institution in determining how they will be applied
- Develop key considerations for institutional policy for Right to Try and Expanded Access