What are Qualified State Therapeutics Access Regimes?
Qualified State Therapeutics Access Regimes (QSTARs) are state-level legal frameworks that create pathways for patients to access treatments that have not yet received full FDA approval. These regimes include:
Right to Try Laws
46 states have enacted laws allowing terminally ill patients to access investigational drugs, biologics, and devices that have completed Phase I clinical trials. These laws remove state-level barriers between patients and potentially life-saving treatments. Some states like Montana have broadened eligibility beyond terminal illness.
Right to Individualized Treatments
Sometimes called “Right to Try 2.0,” these laws allow patients to access treatments designed specifically for one individual based on their genetic makeup, such as gene therapies, antisense oligonucleotides, and neoantigen vaccines. 16 states have enacted these laws since Arizona led the way in 2022.
Stem Cell Access Laws
States like Florida, Utah, Texas, Nevada, and Wyoming have enacted laws allowing patients access to autologous and certain allogeneic stem cell therapies. These laws enable providers to offer regenerative treatments under state regulatory frameworks.
State-by-State Access Map
Hover over or click a state to learn about its therapeutic access laws. The landscape is evolving rapidly as more states adopt these frameworks.
Hover over or click a state to see its therapeutic access laws.
Legend
Striped states have multiple categories. Hover or click for details.
How it works
Eligibility
A patient with a serious or life-threatening condition has exhausted standard treatment options, or no FDA-approved treatment exists for their condition.
Physician recommendation
The patient's treating physician identifies an investigational treatment that has completed at least Phase I clinical trials and recommends it based on the patient's specific condition.
Informed consent
The patient provides written informed consent after being fully informed about the potential risks, benefits, and experimental nature of the treatment.
Treatment access
Under the state's therapeutic access law, the manufacturer may provide the treatment directly to the patient through their physician, outside of the traditional FDA approval process.