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Abstract:
The Coalition for a Stronger FDA commended HHS Secretary Michael Leavitt and FDA Commissioner
Andrew Von Eschenbach for increases in the Food and Drug Administration's fiscal year 2008 budget request and said it would work with Congress to include additional funding to ensure the agency is able to protect American patients and consumers.

FDA Coalition Seeks Increases to Agency Budget

Washington, DC | Posted on February 6th, 2007

"As a nation, we must make sure the FDA has sufficient resources to
protect the food supply while fulfilling its mission to review and approve
life-saving drug and medical device advances for patient use," said Tommy
G. Thompson, former Health and Human Services Secretary and co-chairman of
the Coalition. "This budget proposal is a good starting point in this tight
fiscal year, and we look forward to working with Congress to give the FDA
the additional funding it needs."
The Coalition said the administration's budget request includes
increases in the right areas, including strengthening food safety, at $10.6
million; modernizing drug safety, at $11.2 million; and medical device
safety and review, at $7.2 million.
The Coalition -- a diverse group of consumer, non-profit, patient and
industry groups -- is committed to building on these initial steps as
Congress works through the budget process in an attempt to give the FDA the
resources it needs. 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 increases of $115 million
for food safety programs, $40 million for drug reviews, 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 $115 million increase in the food budget would allow
the FDA to:
-- Address gaps in food safety oversight with enhancements in inspection,
auditing, and compliance.

-- Promote health and wellness.

-- Speed approvals for safe new products and technologies for food.

-- Enhance scientific and policy programs, including risk assessment, risk
management, and analysis.

-- Promote globalization through harmonized, science-based food standards.

-- Provide leadership in food defense.

A $40 million increase in the drug budget 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.

-- Further integrate emerging science into the regulatory process.
A $20 million increase in the medical device budget would allow the FDA
to:
-- Provide at least current service funding to allow maintenance and
improvement of user fee performance goals.

-- Give FDA capability to oversee rapidly advancing technology in the
molecular medicine, wireless systems, robotics, minimally invasive
technologies, and nanotechnology fields. Fund Critical Path for
devices.

-- Maintain balance between user fees and appropriations to assure prompt
and effective approval process.
Bill Hubbard, a former FDA associate commissioner and now a senior
advisor to the Coalition, said the larger increases will ensure that more
modest gains aren't entirely dedicated to pay raises and inflationary
pressures.
"We are concerned that Congress is continually increasing the
responsibilities of FDA, without correspondingly increasing the
appropriations," Hubbard said. "Additional resources will build a solid
foundation for future increases that will help the FDA maintain and build
on its position as the world's foremost consumer protection organization."

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About The Coalition for a Stronger FDA
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.
The Coalition plans to build public support for the FDA and work
productively with the executive branch and Congress to ensure the agency
has adequate resources to fulfill its mission. The Coalition welcomes and
seeks to work in concert with the important ongoing efforts of individuals,
companies, patient and consumer advocates and other groups to convince our
policymakers of the importance of increasing the FDA's entire budget,
including therapeutics, foods, cosmetics and medical products.
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 .