Accelerating Access to Critical Therapies for ALS Act
Dec 23, 2021
Statute: 135 Stat. 1533
Became law: Dec 23, 2021
Dec 23, 2021
Statute: 135 Stat. 1533
Became law: Dec 23, 2021
Summary
Creates grants and partnerships to speed up the development of new drugs and help people with ALS get access to treatments that are still being tested.
What problem does this solve?
People with ALS, a deadly nerve disease, have no cure and often cannot get into clinical trials for new drugs. This law creates new ways to fund research and gives patients access to experimental treatments sooner, potentially saving lives.
What does this law do?
Establishes research grants for ALS therapies
Directs the Secretary of Health and Human Services (HHS) to award grants for research on experimental ALS drugs. The research will use data from patients who get these drugs outside of normal clinical trials.
Creates a public-private partnership for neurodegenerative diseases
Requires HHS to create a partnership between the NIH, FDA, and other groups. The goal is to speed up the development of treatments for ALS and other rare neurodegenerative diseases.
Authorizes $100 million in annual funding
Approves $100,000,000 for each fiscal year from 2022 through 2026 to carry out the activities in the act, such as funding grants and the partnership.
Requires an FDA action plan
Directs the Food and Drug Administration (FDA) to publish a 5-year action plan. The plan will outline how the FDA will help develop and improve access to drugs for ALS and other rare neurodegenerative diseases.
Creates an FDA grant program
Allows the FDA to award grants to public and private groups to cover the costs of research and development of treatments for ALS and other rare neurodegenerative diseases.
Ensures equitable access to treatments
Requires that projects funded by grants must allow for fair access to experimental drugs for people in minority and underserved groups.
Who does this affect?
- People with ALS and other rare neurodegenerative diseases
- Medical researchers
- Pharmaceutical companies
What is the real world impact?
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Speeds up drug development for ALS
Creates new funding and partnerships to accelerate research for ALS, a disease with no cure. This helps scientists and drug makers find effective treatments faster.
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Provides hope for patients
Gives patients who can't join clinical trials a chance to try new, experimental drugs. This can offer hope to people with a terminal diagnosis who have run out of other options.
When does this start?
This law takes effect immediately, with several key deadlines for government agencies over the next four years.
FDA action plan publication
The Food and Drug Administration must publish its action plan for rare neurodegenerative diseases within 6 months of the law's enactment.
Public-private partnership establishment
The Secretary of Health and Human Services must establish the Public-Private Partnership for Neurodegenerative Diseases within one year of the law's enactment.
GAO report to Congress
The Government Accountability Office must submit a report on the law's effectiveness to Congress no later than 4 years after the date of enactment.