Sens. Chris Coons, D-Delaware, and Mike Braun, R-Indiana, co-chairs of the Senate ALS Caucus, led a bipartisan group of 15 U.S. senators and 26 U.S. representatives to urge the commissioner of the U.S. Food and Drug Administration to improve the clinical trial process for those with terminal illnesses such as Amyotrophic Lateral Sclerosis.
Currently, the FDA has only approved two treatments for ALS that slow down the progress of the disease, but there is still no cure. The letter calls for the FDA to take steps to ensure individuals suffering from terminal illnesses, such as ALS, have access to safe and promising treatments in the clinical trial pipeline. The letter requests recommendations from the FDA on ways Congress can help improve the process of getting life-saving drugs to those who need it most.
“There are many ways for Congress and the FDA to continue to work together to ensure people with ALS, and other rare or terminal diseases, have access to safe, promising therapies, while maintaining the foundational and necessary safety and efficacy standards for approval at the FDA,” the letter said in part. “To assist Congress in this continued effort, we respectfully request that you provide, in your reply, specific recommendations for congressional action that will help the FDA facilitate faster access to safe, promising therapies for those Americans struggling with this deadly disease.”
The full text of the letter is available at bit.ly/3cIaTkA.