Press Release

Fortenberry Statement on House and Senate Reintroduction of His Accelerating Access to Critical Therapies for ALS Act (ACT for ALS)

Nov 2, 2020
Press Release
Early Access to Promising Treatments Offers New Hope in Fight against ALS and Improved Infrastructure for Neurodegenerative Disease Drug Development

(WASHINGTON, DC)––Congressman Jeff Fortenberry (NE-01) offered the following statement upon the reintroduction of an updated version of ACT for ALS, Accelerating Access to Critical Therapies for ALS Act, in the United States House and Senate.

The two new pieces of legislation––H.R.8662 in the House and S.4867 in the Senate––creates new pathways for faster and broader access to therapies for those most in need, including those facing a fatal disease like ALS.

“This new legislation represents a monumental shift for those suffering from ALS and other neurodegenerative diseases.  It breaks the paradigm of disease research and creates a new pathway to deliver promising treatments.  With this new law, we can break through faster for those who have suffered so much,” Fortenberry said.

The revised ACT for ALS addresses several challenges associated with ALS therapeutic development.  First, ALS clinical trials do not always employ expanded access programs that facilitate access to experimental treatments outside of the trial.  This legislation tackles the financial barrier for therapies being tested from small biopharmaceutical companies by creating a grant program that funds access to investigational ALS treatments to patients not participating in the clinical trial. Additionally, the grant will fund a research project as part of providing expanded access to people living with ALS, adding to the understanding of how treatments impact the disease.

The revised legislation also invests in neurodegenerative disease research through a new Food and Drug Administration (FDA) Rare Neurodegenerative Disease Grant Program.  With this investment, Congress prioritizes making progress in the development of treatments and cures for ALS and other rare neurodegenerative diseases.

Finally, ACT for ALS would establish an HHS Collaborative for Neurodegenerative Diseases jointly led by the FDA and the National Institutes of Health (NIH), the first federal effort explicitly charged with the responsibility to speed the development and approval of therapies for neurodegenerative diseases.  This collaborative is charged with coordinating efforts across the public and private sector to accelerate therapeutic development and regulatory review of treatments and cures for ALS and neurodegenerative diseases, including:

  • Coordination among the centers of the Food and Drug Administration to achieve the goals specified in the draft guidance entitled “Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry,’’ published in September 2019;
  • Facilitation of access to investigational drugs for ALS;
  • Definition or development of the regulatory and translational pathway for emerging therapeutic categories; and
  • Development and implementation of an ongoing mechanism to share feedback and information and develop strategies with the neurodegenerative disease community, including patients, treating physicians, national organizations that facilitate provision of care services, access and research, researchers, drug sponsors, drug manufacturers and Federal agencies.

The bills have the full support and coordination of three leading ALS organizations in I AM ALS, The ALS Association and the Muscular Dystrophy Association.  The revised ACT for ALS addresses several challenges associated with ALS therapeutic development.

Link to House Bill:

Link to Senate Bill:

Congressman Jeff Fortenberry is the Ranking Member of the House Appropriations Subcommittee on Agriculture, Rural Development, and Food and Drug Administration (FDA).


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