The Promising Pathway Act Saves Lives!
Promising Pathway Act (PPA) H.R. 4408/S.1906
“Red tape bureaucracy delays access to treatment for ALS patients, and those with conditions don’t have time to wait. The FDA’s complex approval process for drugs and therapies only adds to the stress of patients and families weighing various treatment options. Removing barriers and establishing a rolling, priority pathway for the approval of lifesaving treatments is the least we can do.”—Sen. Cramer
"The Promising Pathway Act would open a provisional FDA approval pathway for drugs and therapies that treat conditions where the disease progresses rapidly and few to no treatment options exist while continuing to ensure that these new therapies are safe and effective.”—Sen. Gillibrand
Promising Pathway Act (PPA) H.R. 4408/S.1906 is a bipartisan bill that would require the FDA to establish a priority review pathway to grant provisional approval status for promising drugs intended to treat serious or life-threatening diseases. Provisional approval to promising treatments would mean that treatments that are shown to be safe and effective can be conditionally approved to the public rather than remain in the FDA docket for months to years while the ALS community dies waiting. The PPA would also establish a regularly updated registrar of drug effectiveness to continuously monitor each drug under provisional approval. This ensures all approved treatments for ALS and other rare diseases are beneficial.
The devastating reality of ALS and all Rare Diseases: We Die Waiting For Regulation
Amyotrophic Lateral Sclerosis/Motor Neuron Disease (ALS/MND) is a rapidly progressing, 100% fatal disease. Since its discovery in 1869, every person diagnosed has died from this relentless disease. However, despite what you have been told, ALS is not incurable. It is underfunded and underserved. In recent years, ALS has been marginalized and misrepresented by the U.S. Government. Promising treatments for ALS get delayed and not prioritized by the U.S. Food and Drug Administration (FDA) approval process. The average ALS sufferer lives only 2-5 years, which results in multiple ALS “generations” dying a brutal death waiting for access to life sustaining treatments. The FDA does not regulate terminal illnesses any differently from non-terminal illnesses, which prevents fast-acting, progressive diseases like ALS and DIPG from becoming non-terminal. The FDA approval process is conditional on if and when they decide to follow regulatory flexibility and accept patient testimony. This cruel injustice has been killing people with terminal diseases and giving no hope to find a cure for far too long.
Urge your members of Congress to support the Promising Pathway Act
The Promising Pathway Act (PPA) was proposed on June 8th, 2023 by Senators Mike Brau, Kirsten Gillibrand, Lisa Murkowski, Kevin Cramer and Roger Wicker to help people suffering from ALS and other rare diseases to get access to life saving treatments in time. In order for this bill to get passed in time for the current ALS generation to receive promising, life-saving treatments, we must ask our members of Congress and Senators to co-sponsor this legislation.
We made this hassle-free for you to help save thousands of lives! We provided a form here to send your Representatives an email urging them to support the PPA. All it takes is 30 seconds to enter your name, email address, home address, and phone number. This information creates the signature used on our pre-filled template sent to your members of Congress and Senators, all with just one submission from you.
Yes, it's that easy! So please join us and help ALS and all Rare Diseases live better lives!