Our position on Right to Try and support of people with ALS in our mission to find effective treatments and permanent cures.
Background on Right-to-Try
Right-to-Try laws are U.S. state laws that were created to let terminally ill patients try experimental therapies (drugs, biologics, devices) that have completed Phase 1 testing but have not been approved by the Food and Drug Administration (FDA). In May 2014, Colorado became the first state to pass a right-to-try law. As of June 2016, 30 states have enacted such laws.
In October 2014, ALS.net | ALS Therapy Development Institute issued a public statement on our position on Right-to-Try legislation. In short: "The ALS Therapy Development Institute believes that people diagnosed with ALS deserve to have access to the most up-to-date information about treatment options."
Right-to-Try: The Current State of Affairs
There is currently a bill before Congress that if passed, would:
1. Bar the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law.
2. Define an "experimental drug, biological product, or device" as one that: (1) has successfully completed a phase 1 clinical investigation; (2) remains under investigation in a clinical trial approved by the Food and Drug Administration; and (3) is not approved, licensed, or cleared for commercial distribution under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.
Currently there is a movement called "MyRightToTryNow" that has been garnering significant traction in the ALS space. It supports the Right-to-Try bill and is being led in part by Matt Bellina (pictured with family), who is a person living with ALS, an active ALS.net National Ambassador and longtime ALS.net supporter.
Where ALS.net | ALS Therapy Development Institute Stands Today
Today, based on the heightened attention that the Right-to-Try movement has been garnering within the ALS community and the U.S. Congress, we have decided to formally repeat/remind the community of our position.
The ALS drug development process is a long and challenging one. But our history and leadership in the ALS space solidify our understanding of the urgent need for treatments for everyone affected by this disease.
We believe that individuals with ALS should have access to as much information as possible to help them make informed decisions. For many years, we have led the way in encouraging the sharing of such information between people with ALS, their families and our scientists through our ALS Forum, webinars, ALS Unfiltered series and Leadership Summit. While we remain 100% focused on the discovery and development of effective treatments for ALS, we believe that we also have a responsibility to ensure that people with ALS have access to information about candidate therapeutics currently in trial, those in the pipeline moving towards trials, as well as other experimental or non-traditional approaches.
Those advocating for the currently proposed Right-to-Try legislation should be recognized for leading this important discussion. We support their motivation to explore any and all treatment paths. We will maintain our commitment to provide and share information to support all people living with ALS, as we work together on the discovery and development of effective treatments for ALS.