Reps. Bilirakis, Eshoo, Guthrie, Schakowsky, Quigley, Gallagher, DeLauro and Calvert Urge FDA to Rapidly Approve New ALS Treatments

WASHINGTON, D.C. – U.S. Reps. Gus Bilirakis (R-FL), Anna G. Eshoo (D-CA), Brett Guthrie (R-KY), Jan Schakowsky (D-IL), Mike Quigley (D-IL), Mike Gallagher (R-WI), Rosa L. DeLauro (D-CT), and Ken Calvert (R-CA) sent a letter to the Food and Drug Administration (FDA) inquiring about steps the agency is taking to approve groundbreaking new therapies for ALS and other deadly diseases and urging the agency to take a rapid approach to approving new life-saving treatments.

The bipartisan group of legislative leaders wrote: "People living with aggressive, fatal neurodegenerative disorders such as amyotrophic lateral sclerosis (ALS) need access to safe therapies. With several novel therapies currently being studied or under review, we are hopefully on the cusp of medical breakthroughs to treat this debilitating disease…The FDA has employed a rapid regulatory approach to approve drugs in areas like oncology. We believe the Agency should look to its approach in oncology and apply any best practices that could be used for ALS drug development given the unmet need and the seriousness of ALS. All divisions at the FDA, including the Office of Neuroscience, must act urgently on behalf of people living with fatal diseases."

A PDF of the entire letter can be found HERE.