Right to Try vs. Right to Try 2.0
Right to Try (Original)
The original Right to Try laws, enacted in 41 states and federally in 2018, provide a pathway for terminally ill patients to access investigational drugs, biological products, and devices that have completed a Phase 1 clinical trial. These laws aim to provide hope and a potential last resort for patients facing terminal illnesses, bypassing the full extent of an otherwise lengthy FDA approval process.
Key Characteristics of Original Right to Try:
The original Right to Try permits patients to gain access to drugs that have successfully passed the FDA’s Phase 1 Safety Trials but are still undergoing the Phase 2 Efficacy Trials.
The original Right to Try generally applies to drugs developed for conditions that impact a significant number of patients.
The original Right to Try does not apply to drugs or substances restricted by the Drug Enforcement Administration, nor does it apply to drugs that have not passed the FDA’s Phase One Safety Trials.
Right to Try for Individualized Treatments (Right to Try 2.0)
Building on the success of the original law, the Goldwater Institute is now advancing Right to Try for Individualized Treatments, specifically focusing on individualized, investigational treatments that are highly personalized and on the cutting-edge of therapy for patients with rare and ultrarare diseases. Rapid advancements in medical science have enabled the development of personalized treatments tailored to an individual's unique genetic makeup. These treatments hold immense promise for patients with life-threatening or severely debilitating illnesses, particularly those with rare and ultra-rare conditions. However, the current FDA regulatory framework, designed for drugs mass produced for large populations, presents significant hurdles for the timely access of these individualized therapies.
16 states and counting have already enacted this next generation of the Right to Try movement.
Join The Fight For The Right To Try
As science rapidly advances, medical treatments are outpacing regulations. That’s why we need the Right to Try for Individualized Treatments. Sign up to stay informed and to help us make this the law of the land.
