Patients Win as States Recognize the Right to Try Cutting Edge Treatments

The right of patients, particularly terminal patients, to try experimental drugs and therapies has been a hotly contested issue. The Right to Try Act of 2017 was passed by Congress and went into effect in May 2018 after it was already law in 38 states. It allowed patients to request access to experimental drugs and biologics that have not yet been approved by the Food and Drug Administration (FDA), and exempted some unapproved drugs from certain restrictions. While the legislation was a win for patients, treatments have become more sophisticated and further updates are needed.

Innovation has made it possible to take an individual’s genetic information and create a treatment or drug specifically designed for that person. The FDA’s approval process isn’t designed for individualized treatments and is based on clinical trials with large groups of patients. This means the personalized treatments are subject to the same approval process as any other drug. That reality has driven many states to act to protect patients.

Often referred to as “Right-To-Try 2.0,” these state laws ensure patients with life-threatening illnesses that have exhausted all other treatment options are able to access unapproved individualized treatment options.  North Carolina is the latest state to recognize the right of patients to try cutting-edge and often life-saving treatments. In 2024, Louisiana, Maryland and Mississippi also joined the list of states protecting patients’ rights. ALEC’s Safeguarding the Right-To-Try Cutting Edge Medicine model policy is consistent with many of these state laws, which have experienced bipartisan support.

This is particularly important to those with rare diseases who may not have any other options. Often times, these treatments are already approved in other countries, and patients are leaving the United States to try what could be life-saving care. The FDA’s approval process is outdated and will need significant changes to accommodate individualized treatments. Thankfully, state leaders are working to ensure patients are able to access those treatments.