2007 NIO Public Policy Issue
U.S. Federal Agencies Must Recognize Age Associated Memory Decline
NIO is currently building a coalition of companies interested in pursuing this issue.
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Accelerating Treatments for Memory Decline
Problem. Over 20 million Americans currently suffer from types of memory decline for which few, if any, treatments are being developed. While such memory loss is less severe than dementias like Alzheimer’s disease, it impacts the quality of life of millions of Americans, reducing our economic productivity and competitiveness. Further, early treatment of memory decline may prevent progression to more debilitating forms of dementia, representing billions of dollars in healthcare savings.
Despite the breadth and gravity of this problem, the absence of Food and Drug Administration (FDA) guidance and standards relating to early memory loss makes it too risky for companies to develop therapies for Age-Associated Memory Impairment (AAMI), Age-Related Cognitive Decline (ARCD) and Mild Cognitive Impairment (MCI). Similarly, the National Institutes of Health (NIH) has remained relatively unengaged in research for AAMI and MCI, further stunting advances in the field.
Solution. NIO will work to develop public sector funding and clear standards for AAMI, ARCD, MCI research and development to accelerate the development of treatments for all forms of memory decline. A comprehensive program to spotlight AAMI, ARCD, and MCI with policymakers: including key Congressional funders and NIH and FDA officials, as well as with the public at large.
Specific goals include:
➢ Recognition of AAMI and ARCD as a valid categories for pharmaceutical development
➢ Clear FDA guidance on clinical trial endpoints for MCI, ARCD, and AAMI
➢ Increased FDA and NIH funding for memory decline indications
Implementation. NIO proposes to take the following steps:
➢ Development of relevant data (i.e. medical, economic and social impact of AAMI/ARCD/MCI and follow on advocacy materials);
➢ Congressional hearings on AAMI, ARCD, and MCI; Spring, 2007;
➢ Meeting and discussions with administrative agency officials, including FDA and NIH and HHS;
➢ Presentation to key Congressional funders (e.g. Labor-HHS and Agriculture (FDA funding) appropriations, House Science Committee, Aging Subcommittees)
➢ Work with key members of Press to instigate broad-based public involvement
➢ Meetings with potential policy allies: e.g. AARP, mental health community
Tactics.
Prepare Briefing Materials
NIO will prepare understandable, and regularly updated materials for policymakers, including:
• One-pagers and talking points
• Research data and policy analysis
Presentations to Congress, FDA, HHS and NIH and Congressional Hearings
NIO will bring academics, business leaders and community leaders to meet with policymakers to discuss the problem. Members of Congress with large senior populations and those who have made aging a significant issue will be particular targets.
NIO will also work specifically with Members of the Congressional Subcommittees on Aging to hold hearings on the absence of government support for AAMI, ARCD and MCI. The goal of the hearings will be to spotlight the issue, bring some pressure to bear on the agencies, possibly requiring a short-term report to Congress on the issue, and lay the groundwork for Congressional funding. The hearings will begin with testimony from scientific experts who provide a basic overview of types of memory decline. This will be followed by testimony from neurotechnology entrepreneur CEO’s who have abandoned drug development of their promising memory drugs and neurotech venture capital investors who can not fund companies because of high risk.
NIO is building a coalition of companies interested in pursuing congressional hearings. Please send an email to Zack Lynch, Executive Director, if you are interested in learning more about this coalition.
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