The ALS Association Urges U.S. Food And Drug Administration To Expedite Drug Development And Approval Process At First-Ever ALS-Specific Public Hearing
WASHINGTON , Feb. 25, 2013 /PRNewswire-USNewswire/ -- Today, leaders from The ALS Association, in addition to patients, caregivers, physicians, scientists and other concerned individuals, addressed a panel of representatives from the U.S. Food and Drug Administration (FDA) as the agency conducted its first-ever public hearing specific to amyotrophic lateral sclerosis (ALS). The Association urged the FDA to partner with the ALS community to help expedite the drug development and approval process and bring new treatments to patients as soon as possible. Today, there is no effective treatment for ALS and the disease is fatal in an average of just two to five years following diagnosis.
ALS, also known as Lou Gehrig's Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The disease robs people of the ability to walk, to talk and even blink an eye. It traps them inside a body they no longer can control and ultimately prevents them from breathing as it takes their life. There is no known cause of the disease, although military veterans are approximately twice as likely to develop ALS as the general population.
The day can be summed up in a direct quote from Robert Anderson, a person living with the disease who receives care from The ALS Association's "Catfish" Hunter Chapter. Using a computer-generated voice on his tablet because he can no longer speak, he told the FDA panel: "ALS is fast. We need FDA to be faster."The hearing began early today with remarks from Jane H. Gilbert, President and CEO of The ALS Association, and Lucie Bruijn, Ph.D., Chief Scientist, who were the first to speak among nearly 60 speakers representing every segment of the ALS community and nearly every major ALS organization in the United States. In her opening remarks, Gilbert stated: "The fact that you have so many people and organizations gathered in one place at one time speaks volumes about our collective desire to partner with the FDA and work in unison to speed the development of and access to treatments for ALS." Also in her remarks, Gilbert touched on a variety of key issues that the FDA must consider in order to hasten the availability of and access to treatments:
- How people with ALS view benefit and risk;
- Innovation, flexibility and guidance on clinical trial design;
- FDA engagement with investigators and industry earlier and more frequently during the development process;
- The speed of the regulatory process; and
- FDA engagement with patients and patient organizations, including during the review process.
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