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Dr. Hahn, Congratulations on Your Confirmation to Serve As the FDA

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Dr. Hahn, Congratulations on Your Confirmation to Serve As the FDA Dr. Hahn, Congratulations on your confirmation to serve as the FDA Commissioner. We write to follow-up on your promise to Senators Murkowski and Braun to make real a pathway to provide access to promising therapies to those living with ALS today. The signers of this letter are fighting to save lives. That sentence could be written about any number of terminal illnesses. Today, it is about this generation living with Amyotrophic Lateral Sclerosis (ALS). Not because ALS is unique. Instead, like so many others living with terminal illnesses this ALS generations’ fight to save their lives lays bare that we must fundamentally change how we provide access to promising treatments to those who are simply fighting for a chance to live. ALS was discovered over 150 years ago. Lou Gehrig died from it nearly 80 years ago. It afflicts those as young as nine and can occur in every race, gender and ethnicity. Today someone alive is diagnosed with ALS approximately every 5 minutes. It will take their capacity to use their arms, use their legs, to speak, to eat, and ultimately rob them of their ability to breathe. For most, within two to five years. There are no survivors. Ever. This letter, however, is not about the past. It is about the present and the future which for the fight against ALS is finally bright. For the first time in history, the ALS drug development pipeline includes a diverse array of novel treatments from stem cell therapies to gene therapies like those using antisense oligonucleotides (ASOs) and adeno-associated viruses (AAVs). Not only do these therapies exist, but the science behind them has progressed forward more in the last decade than in the prior 140 years. The hope that this has created in this ALS generation is palpable. This hope has been turned into dire frustration, and indeed, death, for this ALS generation as our current system does not effectively and efficiently provide patients with access to promising therapies prior to full FDA approval. To be clear, FDA and Congress have made sincere efforts to create faster processes for “rare” or “terminal” diseases like ALS. These include Expanded Access Programs, Fast Track Approvals and Right to Try. We truly appreciate those efforts. The existing system, however, fails those living with ALS today. Right to Try and Expanded Access while potentially powerful weapons are nearly unused due to access, funding and regulatory transparency issues. Moreover, the last ALS drug to be approved by the FDA through the Fast Track process took over five years to wind through trials and approvals. Other drugs have been stuck in clinical trials for nearly a dozen years. Under this timeline, tens of thousands of Americans living with ALS died waiting. This reality for ALS and other terminal diseases is unacceptable. It is particularly unacceptable given that those suffering from terminal illness are willing and motivated to accept risks in the treatment trial process to speed the development of effective therapies. So far, these patient voices have been ignored. That ends now. Previous efforts failed to provide a clear, accessible, and funded pathway that would ensure: (i) access to investigational drugs for life-threatening illness where there is no comparable approved therapy; and (ii) that those terminal patients brave enough to sacrifice their bodies for science are guaranteed access to that therapy post-trial if they so desire. It’s time to provide both. Critically neither of these ideas are novel. The first merely requires updating the more than 20 year old Expanded Access Pathway which FDA has used successfully in oncology. The second adopts a practice that is quickly becoming the norm for humane clinical trials, but arrives too late for some trials that are far along the FDA clinical trial process. Both are about making real a simple principle: actually protecting the lives of Americans through a process that works for patients. Those signing this letter represent every political background because this is not a political issue. This is a human rights issue. This ALS generation lives in a time of unparalleled breakthroughs built on public and private funding. It is uniquely cruel to deprive those on whose backs progress is made the opportunity to fight to save their own lives. We recognize that this letter is short on details for both programs. Those will be coming soon as we have already wasted too much time and lost too many lives. Nothing good is easy, but this fight is too important to too many people not to press the fight with urgency today. It’s time. Sincerely, 15,114 ALS patients, caregivers, loved ones, and advocates Brian Wallach Person living with ALS Ady Barkan Person living with ALS Eric Stevens Person living with ALS Stephen Finger Person living with ALS Sandy Morris Person living with ALS Angelina Fanous Person living with ALS Corey Polen Person living with ALS Dan Tate, Jr. Person living with ALS Mike Hensen Person living with ALS Deborah Bellina Loved one of an ALS patient Cathy Collet Lost a loved one to ALS Phil Green Person living with ALS Chuck Haberstroh Loved one of an ALS patient Bryan Wayne Galentine Person living with ALS Christa Thompson Caregiver of an ALS patient Aaron Andre Loved one of an ALS patient Aaron Bogle Lost a loved one to ALS Aaron Dube ALS advocate Aaron Fabbri Health care advocate Aaron Goddard Surviving caregiver of an ALS patient Aaron Harris Lost a loved one to ALS Aaron Hayre ALS advocate Aaron Jennings Aaron Kuo Aaron M Russell Loved one of an ALS patient Aaron Neiderhiser Health care advocate Aaron Shekl ALS advocate Aaron Tincher Loved one of an ALS patient Aaron Bean Loved one of an ALS patient Aarti Bhat Person living with ALS Aayshah Mirza ALS advocate Abbe Gunnink Abbe Klezer Loved one of an ALS patient Abbey Feldpausch Loved one of an ALS patient Abbey Olson Loved one of an ALS patient Abbie Bulaga Loved one of an ALS patient Abbie Kubasky Lost a loved one to ALS Abbie May Health care advocate Abbie Peluso Loved one of an ALS patient Abby Board ALS advocate Abby Carlton Loved one of an ALS patient Abby Chu Person living with ALS Abby Clancy ALS advocate Abby Cook ALS advocate Abby Diehl ALS advocate Abby Dozier Health care advocate Abby Ellis Loved one of an ALS patient Abby Goolsby ALS advocate Abby Green ALS advocate Abby Russell Lost a loved one to ALS Abby Stainbrook Loved one of an ALS patient Abby Wilson Loved one of an ALS patient Abdul Khan ALS advocate Abdulaziz AlAli ALS advocate Abdulkadir Celik Person living with ALS Abdulla AlGhanem ALS advocate Abdullah altın Caregiver of an ALS patient Abelard Begon Caregiver of an ALS patient Abigail Butrym Abigail Cook-Mack Abigail Meuser Loved one of an ALS patient Abigail Seffern Loved one of an ALS patient Abigail Vaughn Lost a loved one to ALS Abigale Svoboda ALS advocate Abner Velasco Health care advocate Abode Batook Person living with ALS Abrahams Landau ALS advocate Acacia Shaw ALS advocate Acar Person living with ALS Ada Probst Ada Yeste Lost a loved one to ALS Adalet Akşun Health care advocate Adam Battersby ALS advocate Adam Behm ALS advocate Adam Benjamin Shea ALS advocate Adam Cohen ALS advocate Adam Gilbert Loved one of an ALS patient Adam Gower Loved one of an ALS patient Adam Hermsen Adam Hoard Loved one of an ALS patient Adam Hurlburt Health care advocate Adam Kupetsky Health care advocate Adam Morse ALS advocate Adam Roubitchek ALS advocate Adam Rybczynski Health care advocate Adam Schneider Loved one of an ALS patient Adam Shamah Loved one of an ALS patient Adam Taisey Health care advocate Adam Wiernusz Lost a loved one to ALS Adam Williams Adam Wilson Person living with ALS Adamson Loved one of an ALS patient Adan McCurtain Loved one of an ALS patient Addie Butler ALS advocate Adela Rodriguez Hijosa Loved one of an ALS patient Adele Luttrell Health care advocate Adele McGee Loved one of an ALS patient Adelina Alija Caregiver of an ALS patient Adil Akar Caregiver of an ALS patient Adina Pelletier Person living with ALS Aditi Narayan Minkoff ALS advocate Adnan Acar Caregiver of an ALS patient Adrian Fennell Loved one of an ALS patient Adrian Jeffries Loved one of an ALS patient Adrian Softic Adrian Torres Loved one of an ALS patient Adriana Fusaro Health care advocate Adriana Janky Loved one of an ALS patient Adriana Muntaner ALS advocate Adriana Santizo Loved one of an ALS patient Adriana Tremoulet Loved one of an ALS patient Adriane Napp Loved one of an ALS patient Adrianne Ward Loved one of an ALS patient Adrianne Wright Loved one of an ALS patient Adrienne Ryan Pinto ALS advocate Adrienne Zerener Knoerzer Lost a loved one to ALS Aeshah alsuwailem Health care advocate Afnan Alanqari Health care advocate Afzal Arain Loved one of an ALS patient Agnieszka Bilicka Agon Alija Caregiver of an ALS patient Agustin Gonzalez Caregiver of an ALS patient Ahmad geith Lost a loved one to ALS Ahmad oqab Surviving caregiver of an ALS patient Ahmet altın Caregiver of an ALS patient Aidan Hennigh Health care advocate Aidan Hennigh Loved one of an ALS patient Aiden Anderson Loved one of an ALS patient Aiden Cimbura Lost a loved one to ALS Aileen Kelley Loved one of an ALS patient Aileen Philbrick ALS advocate Aimee Braman Lost a loved one to ALS Aimee Estes Surviving caregiver of an ALS patient Aimee Hardy Loved one of an ALS patient Aimee Meyers Loved one of an ALS patient Aimee Reynolds Loved one of an ALS patient Aimee Rodgers ALS advocate Aimee Rodgers Person living with ALS Aimee Sagan Poole ALS advocate Aimee Sawyer Health care advocate Airib Sweis ALS advocate
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