2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC23
Submitter : Ms. Bonnie Hogue Date & Time: 05/11/2004 06:05:52
Organization : Alzheimer's Association
Consumer Group
Category :
Issue Areas/Comments
Dr. Mark McClellan, Administrator
Centers for Medicare and Medicaid Services
Care of Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852 May 7, 2004

Re: Docket ID 2004S-0170, Medicare Prescription Drug, Improvement and Modernization Act of 2003, Section 1003 ? Initial Priority List

Dear Administrator McClellan:

The Alzheimer's Association appreciates the opportunity to respond to the Request for Comments for the initial priority research list pursuant to Section 1003 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003. The Alzheimer's Association is the premier source of information and support for the 4.5 million Americans with Alzheimer's disease. Through its national network of chapters, it offers a broad range of programs and services for people with the disease, their families, and caregivers and represents their interests on Alzheimer-related issues before federal, state, and local government and with health and long term care providers. The largest private funder of Alzheimer research, the Association has committed more than $150 million toward research into the causes, treatment, prevention, and cure of Alzheimer's disease.

Medicare and Alzheimer?s disease

Most people diagnosed with Alzheimer?s and related dementias are Medicare beneficiaries. Medicare expenditures for people with Alzheimer?s disease are nearly three times higher than the average for all beneficiaries. In 2000, Medicare alone spent $31.9 billion for the care of individuals with Alzheimer?s disease; this amount is projected to increase to $49.3 billion in 2010.


The Alzheimer?s Association respectfully submits a recommendation for the priority setting process. According to the Request for Comments, the recommendations for research will be reviewed and prioritized by a steering committee composed of representatives from various
components of the United States Department of Health and Human Services. Absent from the list of representatives is the National Institute on Aging (NIA). The NIA conducts and supports research about health issues for older people, and is the primary federal agency for Alzheimer's
disease research. NIA?s mission is to improve the health and well being of older Americans through research, and NIA representatives have the knowledge and expertise to make valuable contributions to the work of this important steering committee. Therefore, we recommend that the NIA be included in the steering committee to review the recommendations for research pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

The Alzheimer?s Association will not submit specific research recommendations within the limited scope of the initial priority list identified in the Request for Comments. We will submit recommendations for the FY 2006 priority list. Thank you for the opportunity to submit our research recommendations in the near future.


Bonnie Hogue William Thies, Ph.D.
Director of Federal Policy Vice President, Medical-Scientific Affairs