September 2011

Senate Committee Acts to Approve More Funds for FDA

Earlier this month, the Senate Appropriations Committee approved a $50 million increase in FDA funding, making the FDA the only nonsecurity agency to evade budget cuts. The Senate’s FY 2012 spending bill for the Department of Agriculture, Rural Development, and Food and Drug Administration designates $2.506 billion to the FDA, a sharp contrast from the budget proposed by the House, a bill reducing FDA funding by $285 million from the previous fiscal year. While generous, the Senate’s spending proposal falls short of the requested $2.747 by President Obama. Under the Senate bill, the FDA’s primary product review centers will not endure substantial budget cuts however these centers will not receive the crucial hikes outlined in Obama’s plan. Instead the approved $50 million increase will implement the Food Safety Modernization Act, an initiative some feel may overwhelm the FDA, an agency already strapped for resources. The Alliance for a Stronger FDA, of which ACT-AD is a member, is meeting with FDA Directors of CDER and CBER to discuss the agency’s resource requirements.

At the same time that the Senate champions were considering how to provide more funding for the FDA in an uncertain fiscal environment, the agency was coming under fire on the other side of Capitol Hill during a House Republican Forum on Jobs and Innovation held on September 20th. Leaders of the medical device industry openly criticized the FDA review process for devices; claiming the agency’s practices are ineffective and hampering innovation. Advocates hope to sway the House by continuing to highlight the important role FDA plays in protecting and promoting public health, but until Congress resolves differences between the House and Senate proposals, the fate of the FDA Budget for FY 2012 remains unclear..

ACT-AD to Host an Experts’ Dinner in San Diego

ACT-AD has co-jointly organized a small networking dinner with the conveners of the Clinical Trials in Alzheimer’s Disease (CTAD) Conference. The dinner will take place in San Diego, CA on the evening of November 4, 2011. The invitation-only dinner is intended to provide a venue where leading Alzheimer’s experts from academia and the private sector can informally share their insights on key topics that should be addressed by ACT-AD in future discussions with the FDA.

As with other ACT-AD-hosted forums, the evening’s program is designed with an eye toward accelerating AD therapy development. Previous dinners have resulted in a physician-investigators consensus letter to the FDA leadership demonstrating the emerging breadth of support for the incorporation imaging and biochemical biomarkers into clinical trials of anti-AD agents and the subsequent formation of a working group on Alzheimer’s disease biomarkers to complete a review of the current utility of AD biomarkers. The results of this review are pending publication in a peer-reviewed journal this year.

More information on CTAD can be found at here.

Alzheimer’s Advocate and Mountaineer Climbs Mt. Kilimanjaro in Honor of World Alzheimer’s Day

Alzheimer’s advocate and mountaineer Alan Arnette is summiting Mt. Kilimanjaro, the highest peak in Africa, as part of The 7 Summits Climb for Alzheimer’s: Memories are Everything campaign. The 7 Summits Climb for Alzheimer’s is a year-long challenge to climb the highest peak on each of the seven continents to help raise awareness of the enormous financial and personal burden Alzheimer’s places on people with the disease, their family caregivers and society. Alan is climbing Mt. Kilimanjaro, his sixth summit this year, in honor of World Alzheimer’s Day, September 21, and the more than 35 million individuals living with Alzheimer’s worldwide.

As a caregiver for his mother, Ida Arnette, who suffered the symptoms of Alzheimer’s disease for nearly a decade until she died in 2009, Alan saw firsthand the urgent need for safe and effective treatments and support for family caregivers. By climbing the 7 Summits, Alan hopes to raise $1 million to advance Alzheimer’s research, provide support for family caregivers and all those affected by Alzheimer’s disease.

The Alzheimer’s Immunotherapy Program of Janssen AI and Pfizer are funding Alan’s climbs so all money Alan raises will go directly to the organization’s he selected: the Cure Alzheimer’s Fund™, the National Family Caregivers Association and the Alzheimer’s Association.

 

The Alzheimer’s Foundation of America to Host 9th Annual National Memory Screening Day

In honor of National Alzheimer’s Awareness Month, the Alzheimer’s Foundation of America, an ACT-AD member, is sponsoring its 9th annual National Memory Screening Day. On November 15, 2011 community sites nationwide will offer free, confidential memory screenings and educational materials to the public.

During the National Memory Screening Day, five to ten minute face-to-face screenings are administered by qualified healthcare professionals (i.e., physicians, psychologists, nurses, nurse practitioners, social workers, pharmacists). Screening sites include Alzheimer’s agencies, assisted living residences, long-term care facilities, doctors’ offices, hospitals, senior centers, YMCA’s, pharmacies and other local venues.

In 2009, nearly 2,200 organizations participated nationwide and an estimated 58,000+ people were screened. To assist in this year’s National Memory Screening Day you can host a screening site, offer to be a screener, encourage people with memory concerns to be screened, or spread the word

For more information visit here.