Lawmakers Push FDA for ALS Therapies

A group of bipartisan lawmakers is urging FDA to do more to help get therapies approved for treating amyotrophic lateral sclerosis (Lou Gehrig’s Disease). Reps. Mike Gallagher (R-WI), Anna G. Eshoo (D-CA), Brett Guthrie (R-KY), Jan Schakowsky (D-IL), Gus Bilirakis (R-FL), Mike Quigley (D-IL), Rosa L. DeLauro (D-CT), and Ken Calvert (R-CA) have written FDA asking how it is using existing authorities to ensure ALS patients and others with neurodegenerative disorders have access to therapies.

The lawmakers noted that FDA has had success in employing a rapid regulatory approach to approve cancer drugs. “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,” they wrote. “All divisions at the FDA, including the Office of Neuroscience, must act urgently on behalf of people living with fatal diseases.”