Right to Try vs. Expanded Access: What Patients Need to Know
When facing a life-threatening condition with no approved treatment options, patients and their families often find themselves navigating complex regulatory pathways in search of experimental therapies. Two distinct routes exist for accessing investigational treatments outside of clinical trials: the FDA's long-established Expanded Access Program, also known as compassionate use, and the newer Right to Try pathway created by federal legislation in 2018. Understanding the key differences, advantages, and limitations of these options is crucial for patients confronting difficult treatment decisions. The FDA's Expanded Access Program has evolved significantly since its formal establishment in the 1980s during the HIV/AIDS crisis. This pathway requires a multi-step process: the treating physician must contact the drug manufacturer to request the investigational treatment; if the company agrees, the physician then submits...
