“Sadly, terminally ill patients often lose their struggle for life because they cannot wait several years for the FDA to approve a potentially life-saving treatment,” said Harris. “While testing new medical treatments is hugely important to ensuring their safety and effectiveness, it is reasonable to allow someone who has been diagnosed as terminally ill to use one of those treatments with the recommendation and supervision of their doctor."
The Right to Try Act provides that an eligible patient with a terminal illness who has considered all other treatment options approved by the FDA may acquire from a manufacturer an investigational drug, biological product, or device that has successfully completed Phase I of a clinical trial, but has not yet been approved for general use by the FDA. The Phase I classification means that preliminary clinical trials have shown the treatment to be promising.
Once a medical treatment has passed the Phase I series of clinical trials it enters Phase II, which generally takes a number years. Phase II seeks to gather statistical confirmation that the treatment succeeds, learn more about side effects and contraindications, and learn more about why and how the treatment works. While Phase II is ongoing, access to a drug or treatment is severely limited – in effect, sharply rationed – by the maker or provider. Since terminally ill patients do not have the ability to wait on the results of such studies, the Right to Try Act allows them to request access to treatments going through Phase II testing, which could be a life-saver.
Should the Right to Try Act become law, Illinois will become the fourth state to pass similar legislation and allow terminally ill patients access to potentially life-saving treatment.