Quigley Statement on the Awarding of the First Expanded Access Grant Under ACT for ALS

Today, U.S. Representative Mike Quigley (IL-05), the author of the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS), released the following statement after the National Institutes for Health's announcement of the awarding of a grant pursuant to Section 2 of ACT for ALS:

"Since President Biden signed ACT for ALS into law in December 2021, federal agencies have been hard at work turning the bill's promise into a reality. I welcome NIH's very first expanded access grant made under ACT for ALS. This is a positive first step in implementing the expanded access to promising treatments envisioned by the bill. Now, Congress must fully fund ACT for ALS to expand access to ever more patients using ever more promising therapies. The access and research made possible by this grant will teach us more about ALS and marks one more step along the road to ending this cruel disease. It will also teach us more about how to administer expanded access studies, a relatively new and underutilized form of research that can bring promising treatments to individuals who have no other options. This is one more step, but it is not the last. I am in the fight against this disease until we have defeated it for good."

Quigley's ACT for ALS directs NIH to issue grants to clinical trial sites to implement expanded access programs for ALS therapies that are currently in Phase 3 clinical trials. Individuals who are unable to participate in clinical trials are eligible for the Act's expanded access programs, ensuring that they can get access to promising therapies while making the research infrastructure broader and more inclusive of ALS patients in all stages of disease progression. This sort of access and research is particularly important in ALS, as the vast majority of individuals living with ALS are not eligible for clinical trials.