On December 23, 2021, we reached a groundbreaking milestone for the ALS community. President Joe Biden has just signed the Access to Critical Therapies (ACT) for ALS Act into law. The Senate voted unanimously to pass the Act on December 16, with it previously passing in the House 432-2 on November 4. This new law is over a year and a half in the making, being first introduced in June 2020. Since then, countless ALS advocates across the country have contacted elected officials over 30,000 times in support of the Act!
To see such tremendous support from our elected officials is proof that there is strong momentum in the fight against ALS. This law is a game-changer not only for those living with the disease, but also the future of ALS research.
Here’s everything you need to know about the two most important sections of ACT for ALS:
Increased Funding for ALS Research
One of the largest hurdles to ALS research is funding. ACT for ALS will alleviate some of that burden by providing researchers the support they need to study the disease. Section 5 of Act for ALS establishes a new Rare Neurodegenerative Disease Grant Program at the FDA.
Through this program, the FDA will award grants and contracts to both public and private entities to cover research costs. The funding would benefit not only ALS research, but also research for other rare neurodegenerative diseases in children and adults.
Specifically for ALS research though, ACT for ALS has secured $100 million in funding each year for ALS research (for FY2022 – FY2026). This is with the caveat that funding must be appropriated by Congress on an annual basis. This funding brings us one step closer to better diagnostic practices, treatments, preventatives, and ultimately a cure for ALS.
Expanded Access to Therapies and Treatments
Even with growing number of clinical trials for ALS, many patients are unable to participate. This causes many to miss their chance at potentially life-saving treatments. Section 2 of ACT for ALS aims to change this through the Grants for Research on Therapies for ALS program. It expands access to experimental treatments for patients who would otherwise be ineligible for ALS clinical trials.
These expanded access drugs are not covered by insurance, making federal funding crucial. This program would provide the necessary funding to entities for these investigational drugs. It does, however, require applicants to demonstrate that their expanded access program will not interfere with ongoing clinical trials.
What Comes Next?
ACT for ALS puts in place a long-term commitment on government entities in the fight against ALS. The FDA is now required to publish an ALS and Other Rare Neurodegenerative Disease Action Plan within six months. This document must detail how the FDA plans to support the development treatment to improve or extend the lives of people with ALS and other rare neurodegenerative diseases.
ACT for ALS also requires the Government Accounting Office (GAO) to publish a report within four years to the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee. This report will review the performance of the new expanded access program and FDA research program. Additionally, the law creates public-private partnerships for these diseases, bringing together the NIH, FDA, and other entities in the search for treatments and a cure.
This amazing victory would not have been possible without the support of the countless ALS advocates across the country. We are also inspired by the brave people living with ALS who used their voice to make this a reality.
The ALS Association in tandem with I AM ALS, and the Muscular Dystrophy Association are deeply committed to advocating for those living with ALS. With this and the immense bipartisan support of ACT for ALS, it demonstrates that we are stronger together as we journey towards a world without this terrible disease.
Together, we can find a cure!
