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ACT for ALS Act Signed into Law, Bringing Hope to the ALS Community

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BREAKING ALS NEWS

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ACT for ALS Act Signed into Law, Bringing Hope to the ALS Community

Today, on December 23, 2021, we’ve 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!

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ALS Association Continues to Put Pressure on the FDA Following the We Can’t Wait Action Meeting

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One month ago on May 25, 2021, representatives from the FDA joined a We Can’t Wait Action Meeting. During this meeting, eight ALS advocates from across the US shared their personal experience with the disease to highlight why those with ALS need expedited access to experimental therapies.

Following the We Can’t Wait Action Meeting, the ALS Association sent a letter to the FDA that requests the agency to reaffirm their commitment to the 2019 ALS Guidance and provide details regarding how they have implemented the guidance.

The FDA’s Response to the Letter

Dr. Patrizia Cavazzoni, Director of the Center for Drug Evaluation and Research sent a response letter to the ALS Association on June 15, 2021. The letter acknowledges the “burden of ALS for patients, their families and caregivers,” noting there is an “unmet need for treatments” for the disease.

We can also assure you that we are exercising the regulatory flexibility described in FDA’s 2019 guidance for industry titled Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment (ALS Guidance) and we continue to commit to doing so,” Dr. Cavazzoni shared in the letter.

The FDA responded positively to the We Can’t Wait Action Meeting, but the ALS community still has grave concerns. The FDA has not clearly communicated what they are doing to expedite the approval of promising treatments for ALS patients. Yet they allow regulatory flexibility for other disease treatments.

The FDA recently used its regulatory flexibility to approve Aduhelm to treat Alzheimer’s. While this is great news for those living with Alzheimer’s and their loved ones, those living with ALS are left to wonder why the same urgency is not granted to them.

In the letter from the FDA, Dr. Cavazzoni shared that they are “committed to exercising [the guidance] when appropriate.” However, the agency does not appear to make any of those considerations for AMX0035. The drug met its primary and secondary endpoints in The Phase 2 Trial and is generally safe. Yet the FDA requires another clinical trial.

Health Canada is already working with Amylyx to bring the drug to market for Canadians with ALS in 2021. Yet Americans with ALS will have to wait years to access the drug. That is if the FDA even allows it to hit the market.

How We’re Moving Forward

The ALS Association is deeply committed to expediting the access to promising drug treatments to those living with ALS. We hope to achieve this by:

  1. Continuing to put public pressure on the FDA
  2. Work behind the scenes to expedite change
  3. Seek greater public accountability for the FDA

Read more about this response and how the ALS Association is implementing the above action items here. Our organization will continue to share important updates as they arise as we continue the fight to end ALS. We will not rest until we find a cure!

Read the Full Letter from the FDA

Read the We Cant Wait Action Meeting Summary

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We Can’t Wait: ALS Advocates Urge the FDA to Expedite Access to Experimental Therapies

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The average life expectancy for someone after an ALS diagnosis is only 2 – 5 years. However, the process of developing, testing, and approving new treatments takes far longer. For those living with ALS, time is limited—We Can’t Wait.

On May 25, 2021, representatives from the FDA joined a We Can’t Wait Action Meeting. During this meeting, eight ALS advocates from across the US shared their personal experience with the disease to highlight why those with ALS need expedited access to experimental therapies.

Compelling Testimonials from the ALS Community

John Robinson from Parish, FL, a member of the board of trustees of the ALS Association and retired military veteran of nearly 32 years, was diagnosed with ALS in 2019. ALS not only affects the person with the disease but also their family caregivers. Both he and his wife can no longer serve their communities in the same way because of ALS. “The loss to society of their skills and humanity leaves holes never filled the same way again.”

Sunny Brous, a Texan with ALS, joined the call to share her perspective. Sunny was diagnosed with ALS in 2015 at the young age of 27. For Sunny, access to experimental treatments go beyond extending her own life. “Expanded access is how I can contribute to finding a cure for ALS. It takes my love for others and makes it a quantifiable action combining research and science and my dedication to the greatest good of people living with ALS.”

Sandy Morris, from Truckee, CA played a recorded message. She tearfully shared how many of her friends with ALS died waiting for access to life saving drug treatments. “Think about how much better it would be if we were able to die trying rather than die waiting,” she shared, urging the FDA to consider how their delays harm those living with ALS. “It’s not within my power to save my life—it’s within yours.”

Troy Fields from Champa Bay, FL was diagnosed with ALS in 2018. He noted how the considerations of benefits versus risk should be put in the hands of those living with ALS. “Because unless it is your own life on the line, you simply do not get it.”

Cari Meystrik from Nashville Tennessee was diagnosed with ALS in 1998 when she was only 28 years old. She has watched hundreds of friends die from this awful disease. “Would I jump to try a drug that might help me live longer of a disease that I am dying from if it has already proven to be sage and well tolerated but isn’t approved yet? Absolutely. Give me that chance.”

Jay Quinlan from New Orleans joined with his wife and caregiver Stephanie. “You have shown through your recent handling approvals for COVID vaccines that flexibility and expediting processes are possible.” He asked the FDA to use the same urgency when it comes to approving drug treatments for those living with ALS.

Tommy May from Pine Bluff, AR was diagnosed with ALS in 2005. Due to slow progressions, he was both unable to participate in clinical tries and frustrated with the lack of access to treatments. He discussed how those living with ALS are desperate for HOPE on their path. “We are not interested in the long-term. We are desperate for the here now.”

Larry Falivena of Apex, NC, has ALS caused by a mutation of the SOD1 gene. The fight for treatment access is not just for himself—it is also for his children. “I’m asking the FDA to help make sure my boys don’t have to worry about ALS.” He shares that even if the opportunity exists for just a small number of patients to have extended time on this earth that they need that chance.

Where Do We Go from Here?

In 2021, the ALS Association is committed to accelerating the development, approval, and access to affective new treatments. We will do this by re-introducing and passing the Accelerating Access to Critical Therapies (ACT) for ALS Act and the Promising Pathway Act, so the FDA is fully equipped to speed ALS trials and drug approvals. We will discuss these matters further during the annual ALS Advocacy Conference in June.

It is our sincere hope that the testimonials of these individuals and those who sent written stories will compel the FDA to make actionable changes for the ALS community. Time is off the essence—We Can’t Wait.

Submit your testimony to the FDA

Register for the Virtual ALS Advocacy Conference

Read Our 2021 Advocacy Priorities

Telehealth Coverage for Speech Therapy Services Extended through the Duration of the COVID-19 Pandemic

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In a huge win for the ALS community, the Centers for Medicare & Medicaid Services (CMS) expanded telehealth coverage for speech therapist services for the duration of the COVID-19 pandemic. This victory was made possible through the collaboration of the ALS Association and the American-Speech-Language-Hearing Association (ASHA).

Kathleen Sheehan, Vice President of Public Policy at the ALS Association shared, “These changes will allow speech therapists at ALS clinics and throughout the country to continue treating patients in the safety of their homes and cover services that can be done effectively using telehealth.”

Now there are FIVE critical services available via telehealth for people with ALS including clinical care for swallowing function and evaluations for speech-generating devices. These services are critical to people living with ALS and the day-to-day challenges they face.­

Prior to the COVID-19 pandemic, telemedicine was not widely available because of virtual platform restrictions and insurance barriers. Widespread access to telehealth became an urgent need for those with ALS and other vulnerable groups as the pandemic progressed and clinics closed.

The ALS community, ALS Association and other disease organizations advocated for new guidelines to remove the barriers to telemedicine. Because of this, Texans with ALS were able to access care across the state that was not possible before COVID.  But the fight is not over yet.

These guidelines will expire at the end of the current public health emergency, estimated to last through the end of 2021. However, the ALS Association is dedicated to continuing the fight for permanent expansion of these guidelines to provide access to telehealth services post-COVID-19. This is just one of several public policy priorities for 2021.

We have recently seen promising development on Capitol Hill in the progression of this fight. The ALS Association endorsed the Telehealth Modernization Act through written testimony in March. This act would make telehealth access permanent for Medicare beneficiaries. This would not only impact access to remote care, but also access to remote clinical trials in the search for a cure for ALS. Read the full announcement here.

View our 2021 Public Policy Priorities

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ALS Advocacy in Action: Collin’s Letter to His Senator

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Fort Worth local Colin Hadley is an ALS Hero and inspiring PALS who advocates for the rights of those living with ALS. Read his letter to his Senator, urging him to consider supporting life changing legislation that could improve the quality of life for many patients:

On October 24, 2014 I was given a death sentence…I was given a diagnosis of ALS for which there is no cure and there are no treatments to stop the disease. It isn’t a matter of IF I and other ALS patients will die, it is inevitably WHEN each of us will die.

That day I thought of things that I was looking forward to later in life that would never occur now, such as walking my daughter down the aisle on her wedding day, or playing with grandkids. I gave myself one day to be sad, mad, and bitter. The next day I said I was going to take advantage of the time I have left to make as many memories as possible with my family.

My family and I adopted a motto that we have lived by each and every day: ‘Don’t Count the Days…Make the Days Count’. We’ve done a great job making the days count with over 25 trips in 4.5 years.
There are 3 reasons why I could make those memories with my family and why I am still alive and able to speak to you today: [Read more…]

Advocates take to Capitol Hill to Inspire Change

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On June 9th-11th fourteen ALS advocates from Texas, along with our Executive Director and Sr. Director of Mission Delivery, made their way to Washington D.C. for ALS Advocacy Day. They joined 650 advocates from around the country to meet with lawmakers, share their ALS stories, and let members of Congress know why the time to act is now.

Sr. Director of Mission Delivery Steve Morse with Texas advocates Mike and Linda

Our Priorities

The ALS Association is at the forefront of public policy, working to improve the lives of people living with ALS and their caregivers. This year, our legislative priorities included:

  1. Passing the ALS Disability Act to waive the five-month waiting period for patients with ALS before receiving benefits under Social Security Disability Insurance
  2. Preserve and increase federal resources for ALS Research through the Department of Defense, National ALS Registry, and National Institutes of Health
  3. Oppose competitive bidding for noninvasive ventilators, a critical life support for Medicare beneficiaries with ALS

In addition to these priorities, the ALS Association is working to identify achievable ways improve home health access for people living with ALS through regulatory and legislative action.

Our Impact

During Advocacy Day, our advocates had successful meetings with lawmakers like Joel Heimbach, Ted Cruz (pictured above), Veronica Escobar, Jodey Arrington and more and we couldn’t be prouder of the representation and strides made for people living with ALS.

In great news- Representative Veronica Escobar (pictured above) committed to sign the “Dear Colleague” letter to oppose the addition of noninvasive ventilators to the Competitive Bidding program and she committed to signing onto the bill to eliminate the SSDI 5-month waiting period for ALS patients. She also expressed interest in attending the ALS multidisciplinary clinic at Texas Tech Health Sciences Center in El Paso. Thank you Representative Escobar for your listening ear and for standing with us on these important issues!

In more great news- Texas advocate John Wynn (pictured above) also met with Congressman Kevin Brady. Congressman Brady made this statement about his meeting:

Moving visit last week from veteran John Wynn and ALS advocates. Thank you to the ALS Association of Texas for your work to improve the lives of individuals like Mr. Wynn who are living with ALS. Texas has 11 clinics across the state dedicated to research and patient care, including one at Memorial Herman in Houston. Thank you for sharing your story, Mr. Wynn. I’m proud to support ALS efforts in Congress.

Thank you Congressman Brady for standing with those living with ALS and supporting our efforts to make a positive change.

Our advocates did an amazing job speaking for their fellow PALS on Capitol Hill. Since our time in DC one-hundred more representatives signed our “Dear Colleague letter” urging the opposition of non-invasive ventilators, making the total an impressive one hundred and eighty signatures – a testament to our advocates who attended the conference or sent emails throughout the campaign.

The House Appropriations Defense Subcommittee also approved $20 million in fiscal year 2020 for the DOD ALS Research Program (ALSRP) – doubling the funding amount. This is a huge achievement in a program area that rarely sees increases of such magnitude, and it is a direct result of the advocacy of The ALS Association and our advocates.

Are you interested in inspiring change for those living with ALS? Become an advocate today!

Why The Five-Month SSDI Waiting Period For People With ALS Needs to Be Eliminated

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Pictured: Mary Johnson, Caregiver

Last week the ALS Disability Insurance Act was reintroduced in the 116th Congress. The bill (S.578) aims to eliminate the five month waiting period for disability insurance benefits for those with ALS.

Because of the nature of ALS, and how rapidly symptoms can arise and progress, people with ALS simply do not have five months to wait. They deserve their benefits, that they earned, immediately. Mary Johnson, a caregiver from Pennsylvania whose family has the genetic form of ALS, has lost 14 family members to the disease. One of those family members, her niece, passed away only four months after her diagnosis.

“Over the course of a five-month waiting period, people living with ALS will have only experienced progressive loss of function and will have incurred significant expenses for care and treatment,” said Calaneet Balas, president and CEO of The ALS Association. “We urge Congress to pass this legislation and remove the arbitrary five-month waiting period that creates an unfair financial burden on people whose life expectancy is so tragically abbreviated.”

Because of advocacy from our community, last year the bill was introduced and gained traction. Seven months later, for the first time ever, the bill was unanimously considered for passage through the senate. We have hope that this bill can pass, and we need your help to make it happen!

Ask your members of Congress to cosponsor this bill today to keep the momentum going!

Also tweet or share your support on Facebook, in order to spread the word. Together we can make a difference for people with ALS.

Tweet Your Support!

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ALS Advocacy in Glasgow: One Advocate’s Experience at the 29th International Symposium on ALS/MND

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On December 4th, 2018 ALS Advocate Sunny Erasmus  joined scientists, health care professionals, and other fellow PALS as they made their way to Glasgow, Scotland for the 29th international symposium on ALS/MND. During the 5-day symposium attendees and speakers shared information on the latest research, discussed future collaborations, and had discussions about patient care services. The ALS Association was also in attendance, joining other members of the International Alliance of ALS/MND Associations to exchange information about the care and support of people with ALS/MND everywhere.

Here’s a short summary of some of the panels Sunny attended during her three days in Glasgow: [Read more…]

How Sunny Erasmus is Raising Her Voice for ALS

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Since being diagnosed with ALS in 2015, right before her 28th birthday, Sunny Erasmus has become a warrior for others with the devastating disease. “There are many things that ALS has taken away from me”, she says, “but my voice is loud and persistent in the fight to end this disease”.

In May of 2018 she was one of 570 ALS advocates who made their way to Washington DC for the National ALS Advocacy Conference. There, people with ALS, their friends, and their families were able to make their voices heard and speak up for those who no longer can.

Twenty-two Texans traveled to Washington, D.C., in May to attend the National ALS Advocacy Conference.

At the conference advocates like Sunny learned about the latest ALS research, care service programs, and advocacy efforts to prepare them for meetings with Texas congressional staff and representatives. During those meetings advocates fought for public policy initiatives that would improve the lives of people with ALS, including:

  • Ensure at least $10 million in appropriations for the ALS Registry at the Centers for Disease Control (CDC).
  • Ensure at least $10 million in funding for the Department of Defense’s (DOD) ALS Research Program.
  • Support increased funding for the National Institutes of Health (NIH) in FY2019, especially in the National Institute of Neurological Disorders and Stroke (NINDS).
  • Pass the ALS Disability Insurance Access Act (S.379/H.R.1171) to waive the five-month waiting period for patients with ALS before receiving benefits under Social Security Disability Insurance.
  • Educate and influence Congress and Administrative officials to remove complex barriers to Medicare home health benefits for people living with ALS.

Sunny called the conference one of the most impactful experiences of her life, where she learned about what it means to be an advocate, what to advocate for, and the progress that’s being made by other ALS advocates along the way. “Keeping up energy and focus is hard”, she says, “but advocating for my fellow ALS soldiers has sparked a fire in me that will never go out”.

It’s advocates like Sunny that spark energy to create change in public policy and beyond. Interested in becoming an advocate? Sign up today!

 

Texans Travel to Washington, D.C., to Advocate for People with ALS

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Twenty-two Texans traveled to Washington, D.C., in May to attend the National ALS Advocacy Conference.

More than 570 ALS advocates from across the country joined together for the 2018 National ALS Advocacy Conference in Washington, D.C., on May 13-15. Nearly every state in the country was represented, with 22 advocates hailing from Texas.

Stacey Crowder was one of the Texans who went to D.C. to advocate for People with ALS. Stacey was diagnosed with ALS on August 11, 2016. He’d first noticed a slight twinge in his left bicep earlier that year, and when he received an ALS diagnosis, it took him and his family on an emotional roller coaster. At first, Stacey was devastated and scared, but he was able to cope by relying on his spirituality and the support of his friends and family.

[Read more…]