ALS Community Responds to FDA Guidance Document with Call for More Urgency, Flexibility

The ALS Association and its partners submitted comments to the Food and Drug Administration to further inform the agency’s implementation of the final guidance on the development of drugs and treatments for ALS. The comments underscore the need for urgency and commend the FDA for including voices from our community in its rule making process. Click here to view the comments.

The ALS Association has been working closely with members of the ALS community and the FDA to create a landmark, patient-led guidance initiative that will help drive ALS drug innovation more quickly from the laboratory to the patient, providing feedback to the agency, hosting a national workshop, and creating a report that informed finalization of the guidance. 

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ALS Association Joins Coalition Partners to Lead Fight for Access to Noninvasive Ventilators

A bill championed by The ALS Association was introduced in Congress today that would remove noninvasive ventilators from Medicare’s competitive bidding program. Reps. Morgan Griffith (R-Va.), Peter Welch (D-Vt.), Gus Bilirakis (R-Fl.), John Larson (D-Ct.), and Darren Soto (D-Fl.) have introduced H.R.4945, the Safeguarding Medicare Access to Respiratory Therapy (SMART) Act of 2019.

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How ALS Association Advocates Boosted Congressional Funding for ALS Research

Last week Congress passed, and the president signed, a continuing resolution that will fund all federal programs at current levels through November 21. Before the continuing resolution expires, Congress must either pass full appropriations bills for the 2020 fiscal year or pass another continuing resolution. 

Now that a government shutdown has been averted until just before Thanksgiving, it is worth reflecting on the hard work and success The ALS Association and its advocates have had in securing funding for ALS research and to look ahead to what’s next.

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ALS Association Thanks Community Following FDA Release of Final Guidance Document

On Monday, the Food & Drug Administration (FDA) issued a finalized ALS Drug Development Guidance for Industry. This is one important step in comprehensive efforts to bring therapies to people with ALS more quickly. Five years ago, there was no clarity around what the FDA expected from companies pursuing ALS treatments. The ALS Association recognized this problem, galvanized the broader community, and engaged the FDA to provide a clear roadmap that also can respond to new science as it emerges. The FDA Guidance is one part of a commitment that will not be complete until we have a cure for all people with ALS. 

The ALS Association is in the process of carefully reviewing the final guidance document. We are grateful to people with ALS and their caregivers who have contributed to this process and we thank the FDA for incorporating this input, as well as recognizing the devastating impact of ALS. 

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Principles for Urgent, Patient-Centered ALS Clinical Trials Latest in Ongoing Effort to Improve Trial Design

The ALS Association is deeply committed to accelerating the development of novel ALS therapies and ensuring they are accessible to those who need them. The Association is announcing today its latest strategic action with the release of Principles for Urgent, Patient-Centered ALS Clinical Trials: a series of recommendations to clinical trial sponsors and regulatory bodies worldwide. 

The Principles set out a clear framework for the design and conduct of ALS clinical trials that are efficient, impactful, and respectful. We view them as essential to both maximize the participation of people with ALS and their caregivers and to ensure every available tool is used to streamline drug development and regulatory-review processes. Regardless of the detailed specifics that may arise from FDA guidelines in the next few weeks, we hope these principles can help focus trial sponsors and regulators on the most important aspects of trial design and lead to ever-improving clinical trials as our fight against ALS advances. 

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ALS Advocates Take Action During Congressional Recess

With Congress home for the August recess, The ALS Association is redoubling its efforts to build upon momentum toward achieving a long sought policy goal – the elimination of a five month waiting period for Social Security Disability Insurance. 

During the summer recess, ALS Association chapters are focused on completing in-district meetings with members of Congress who have not already cosponsored the ALS Disability Insurance Access Act and urging them to support this bill. By increasing the number of cosponsors on this bill, we increase the chances of passing the bill before the end of the 116th Congress. 

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Understanding the Impact of the Ice Bucket Challenge on The ALS Association’s Finances

The ALS Association has always been committed to transparency, including providing complete and accurate financial information on our website. We continue to receive the highest ratings from charity watchdog groups tasked with reviewing our spending, fundraising, and management.

The Ice Bucket Challenge generated $115 million for the national office of The ALS Association in 2014, which spurred a massive increase in the Association’s capacity to invest in promising research, the development of assistive technologies, and increased access to care and services for people with ALS. Since 2014, we have committed more than $131 million toward our mission, including over $89 million committed specifically to worldwide research collaborations.

Since that time, the Association has devoted a page on our website to provide a list of how those funds are being spent. You can always find that information by clicking on the “Ice Bucket Challenge Progress” button on our homepage, or you can view those investments here.

After the Ice Bucket Challenge in 2014, The ALS Association’s Board of Trustees determined that the best use of these proceeds was to immediately put them to work by increasing funding in our core mission areas. As a result, we doubled our operating budget, with most of the increase allocated to research and care service initiatives.

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