DIA 2018 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: IACET 0.50

Issues surrounding gravely ill patients who have exhausted all possible treatment options are amongst the most heart-wrenching, complex bioethical and legal challenges of our time. The “Right to Try” movement seeks to ameliorate these issues by stating that terminally-ill patients have the right to save their own lives, by requesting access to experimental interventions early in clinical development. Despite significant questions regarding whether such laws would effectively provide greater access to experimental drugs than is already allowed under often-ignored federal regulation, and a host of troubling provisions embedded in the legislation, nearly 40 states have enacted Right to Try laws, and 2 notable federal bills recently passed the House and Senate, setting the stage for a potential national “Right to Try.”

In addition to illuminating this fascinating and unique case study in political advocacy, this talk will examine the emotional, legal, medical, and ethical dimensions raised by the Right to Try movement.

Learning Objectives

Analyze practical, ethical, operational and regulatory considerations that factor into evaluating patient requests for pre-approval (compassionate use) access to experimental interventions; Identify the key provisions in state and federal RTT laws, and describe the benefits and potential harms central and ancillary portions of these laws; Appraise the current climate giving rise to the vast demand for pre-approval access, and propose measures that could ameliorate the field.

Chair

Beth E. Roxland