Overview
The Right to Try Act expanded pathways for certain terminally ill patients to seek investigational treatments and was signed in May 2018. Congress.gov hosts S. 204. It is distinct from FDA expanded-access programs, which remain separate regulatory pathways.
Full article
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act created a federal statutory pathway related to investigational drugs for eligible patients with life-threatening illnesses. It was signed on May 30, 2018.
Patients, physicians, and sponsors must follow the statute and applicable FDA guidance. This page does not provide medical or legal advice; it documents the legislative milestone.
Key points
- Signed May 30, 2018 (S. 204, 115th Congress).
- Addresses access to certain investigational treatments.
- Congress.gov hosts the official bill text.
- Separate from traditional FDA expanded-access (compassionate use) processes.
- Consult statute and FDA materials for eligibility and manufacturer participation.
Official record
Congress.gov bill page for S. 204 is the linked official source.
Source attribution: View original official record