Understanding the Right to Try Act.

Area of Science:

• Oncology
• Pharmacology
• Health Policy

Background:

• Patients with advanced cancer often exhaust standard treatments.
• Access to investigational drugs through clinical trials can be limited by trial availability and eligibility criteria.
• Patients frequently seek investigational agents outside of formal clinical trials.

Purpose of the Study:

• To review the federal "Right to Try" legislation.
• To clarify the provisions and implications of the Right to Try law for accessing investigational drugs.
• To assess the current awareness and understanding of this legislation.

Main Methods:

• Review of the federal "Right to Try" legislation.
• Analysis of the law's framework for off-study investigational drug administration.
• Commentary on patient access to eligible investigational agents.

Main Results:

• The Right to Try law provides an alternative to the FDA's Expanded Access program.
• Limited awareness and significant misunderstanding of the law persist.
• The law facilitates off-study drug use when all parties (patient, physician, manufacturer) agree.
• It does not compel providers or manufacturers to supply drugs or cover costs.

Conclusions:

• Eligible investigational drugs must be unapproved, have completed Phase I, have an ongoing pivotal trial, and an active registration plan.
• The Right to Try law aims to improve access to investigational drugs outside of clinical trials.
• Further education is needed to ensure proper utilization of this legislation.