12.16.21

ACT for ALS Act Unanimously Passes Senate, Heads to President Biden for His Signature

Following passage in the House, the Senate unanimously passes landmark investigational therapy bill for ALS patients

Today, the U.S. Senate unanimously passed the Accelerating Access to Critical Therapies (ACT) for ALS Act, legislation introduced by U.S. Senators Chris Coons (D-Del.) and Lisa Murkowski (R-Alaska) and U.S. Representatives Mike Quigley (D-Ill.) and Jeff Fortenberry (R-Neb.). The bipartisan, bicameral bill passed the U.S. House of Representatives last week. The ACT for ALS Act would fund essential research into fast-progressing rare neurodegenerative and terminal diseases, like amyotrophic lateral sclerosis (ALS), and early access to promising investigational therapies for patients suffering from them and would authorize $100 million annually to implement these priorities.

ALS affects 1 in 300 people, often leaving patients with no more than three years to live following their diagnosis, and disproportionately impacts U.S. military service members. ACT for ALS authorizes new grants to support expanded access and research programs. This expansion will bring investigational treatments for rapidly progressing diseases beyond their ongoing clinical trials to patients with diseases for which effective therapies don’t already exist and allow for additional research into the effectiveness of those interventions. It also creates a new Food and Drug Administration (FDA) Rare Neurodegenerative Disease Grant Program to support other research and development on ALS and other life-threatening or severely debilitating neurodegenerative diseases.

“Tonight, because of the tireless work of so many ALS advocates, the Senate unanimously passed the ACT for ALS Act and sent it to President Biden’s desk,” said Senator Coons. “Thanks to this legislation and the crucial research into ALS it will fund, countless Americans and their families who face down this cruel disease every day can go to sleep tonight with a renewed sense of hope. I am grateful to Senator Murkowski and Representatives Quigley and Fortenberry for their partnership on this landmark bill.”

“This is all about hope. The ACT for ALS Act will make a meaningful difference for individuals and families across the country. Passage of this bill today is a hard-earned win for the ALS community and provides much-deserved hope to all who are affected by this disease,” said Senator Murkowski. “As someone whose family has been impacted by ALS, I know how terrible this disease is and how tirelessly the ALS community continues to fight for legislation to improve treatments and quality of life and search for a cure. This bill now heading to the President’s desk is huge step forward. It will offer new hope for those who are most in need, those who today—tragically—have very few options for treatment.”

“I am thrilled that the Senate has passed ACT for ALS and officially cleared the way for this life-saving, transformative legislation to be signed into law. For too long, the diagnosis of a neurodegenerative disease like ALS has been a death sentence that included the devastating hopelessness of no effective treatment options. ACT for ALS will finally help people living with this cruel disease access promising treatments and create the research infrastructure that could put a cure within reach,” said Representative Quigley. “I am deeply grateful for the hard work and dedication of the Senate co-leads Senators Chris Coons and Lisa Murkowski and of my House co-lead Congressman Fortenberry. But, above all, I am grateful for the tireless advocacy of an entire community who has made the dream of this accomplishment a reality.”

“In a true Christmas miracle, tonight the U.S. Senate gave real hope to those suffering from the cruel, merciless disease of ALS. For over 50 years and over 50 clinical trials, ALS patients have submitted themselves to tests and trials, therapies and placebos, in accordance with the rules of the current health care policy framework. But progress has been uneven, even debatable, with serious impediments to promising new treatments. Many ALS patients have sacrificed their lives to science, as they gradually weakened and died. Tonight, this Congress advanced a new way,” said Representative Fortenberry. “ACT for ALS represents a monumental shift for those suffering from ALS and other neurodegenerative conditions. The bill does two main things: it transforms the paradigm of disease research and regulation and creates a new pathway to promising new treatments. It drives the hope. With this transformative piece of public policy, we can break through faster for those who have suffered so much. I am deeply grateful to Representative Quigley and Senators Coons and Murkowski for their partnership on this groundbreaking legislation.”

“For one hundred and sixty years, there has been no hope for those diagnosed with ALS. That changed tonight. Tonight, as a result of tens of thousands of ALS advocates working nonstop to make their voices heard and demanding the chance to live, hope has finally come to people living with ALS,” said Brian Wallach, co-founder of I AM ALS. “Thanks to the relentless work of Senators Coons and Murkowski as well as Representatives Quigley and Fortenberry, ACT for ALS has now passed both the House and the Senate and is on its way to President Biden. This moment was supposed to be impossible. The ALS community, however, refused to give up. So today, we celebrate the impossible becoming real and a new chapter for the fight against ALS.”

“ACT for ALS will directly impact the lives of people with ALS by providing expanded access to investigational drugs and funding new research at FDA to find treatments and cures that are urgently needed. Thank you to people with ALS and their families, ALS advocates, and to Congress for passing this historic bill,” said Calaneet Balas, President and CEO, The ALS Association.

“The Muscular Dystrophy Association is incredibly grateful for our champions, Senators Coons and Murkowski as well as Congressmen Quigley and Fortenberry, for every Senator who prioritized the ALS and rare neurodegenerative disease communities by passing the ACT for ALS tonight, and for all patient advocates who spent countless hours pushing for this bill,” said Paul Melmeyer, Vice President of Public Policy and Advocacy at MDA. “With tonight’s vote, this legislation, which could substantially increase access to promising therapies and advance drug development in rare neurodegenerative diseases, needs only President Biden’s signature to make this a reality.”