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Alzheimer's Growth Shows Need for Increased FDA Funding

Coalition for a Stronger FDA says drug review programs need more money

WASHINGTON, March 21, 2007 /PRNewswire-USNewswire/ -- A new estimate by the Alzheimer's Association shows that more than five million Americans are living with Alzheimer's disease -- a 10 percent growth over previous estimates and a number that could more than triple in the coming decades unless new treatments and cures are developed for the debilitating illness.

The new numbers re-emphasize the need for a strong and adequately funded drug safety review program at the Food and Drug Administration to ensure that new Alzheimer's disease drugs can be safely and rapidly brought to market, according to the Coalition for a Stronger FDA.

"As the population ages, more and more American families will be touched by Alzheimer's disease," said Tommy G. Thompson, co-chairman of the Coalition and the former Secretary of the Department of Health and Human Services. "We simply can't afford for the FDA to be a bottleneck for new drugs and treatments because it is not adequately funded."

The Alzheimer's Association estimates that without a cure or effective treatments to delay the onset or progression of Alzheimer's disease, the prevalence could soar to 7.7 million people with the disease by 2030 and 16 million by the middle of the century. More information on the Alzheimer's Association report can be found at http://www.alz.org/news_and_events_rates_rise.asp.

"The funds needed by the FDA will be repaid hundreds of times over in health care savings by getting new Alzheimer's disease drugs quickly and safely to market," said Stephen McConnell of the Alzheimer's Association, a member of the Coalition. "It's an investment we can't afford not to make."

"We are committed to delivering transformational therapies to Alzheimer's patients within the next decade," said Daniel Perry of Accelerate Cure- Treatment for Alzheimer's disease, a member of the Coalition. "A lack of sufficient FDA appropriations stands in the way of delivering treatments that could lessen the human and economic tolls that Alzheimer's exacts on patients and their loved ones."

The Coalition for a Stronger FDA -- a diverse group of consumer, non- profit, patient and industry groups -- is committed to working with Congress and the administration to give the FDA the resources it needs to fulfill its mission. As part of a five-year process to significantly expand the agency's budget, the Coalition is seeking $175 million in increases for 2008 over the fiscal year 2007 budget, including $40 million for drug review programs, $115 million for food safety programs and $20 million for medical device programs.

The increases will allow the FDA to build confidence in the public health system, speed innovation in medical technology, ensure the United States remains competitive in foreign markets, and boosts public confidence in the agency and its mission.

Specifically, a $40 million increase in the drug budget in 2008 would allow the FDA to provide faster and safer approval of products that are saving lives and transforming health care; promote new drug technologies that will revolutionize pharmaceutical therapies and ensure continued U.S. leadership in drug innovation; enhance the surveillance capability over new drugs once they reach the market; and further integrate emerging science into the regulatory process.

About the Coalition

The Coalition for a Stronger FDA is designed to be a multi-year effort with the following goals: (1) making sure the FDA has sufficient resources to protect patients and consumers and (2) maintaining public confidence and trust in the FDA. Tommy G. Thompson, Donna E. Shalala and Dr. Louis Sullivan -- the last three Secretaries of the Department of Health and Human Services -- are the co-chairs of the Coalition. Member organizations of the Coalition include patient groups, consumer advocates, public health organizations and innovative companies. A list of members and more information on the Coalition can be found at http://www.fdacoalition.org.

CONTACT: Tony Jewell, +1-202-530-4510, for Coalition for a Stronger FDA

Web site: http://www.fdacoalition.org/http://www.alz.org/news_and_events_rates_rise.asp/

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Posted: March 2007

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