FDA Coalition Seeks Increases to Agency Budget

WASHINGTON, Feb. 6 /PRNewswire-USNewswire/ — 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.

“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.”

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.

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/.

Coalition for a Stronger FDA

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

Web site: http://www.fdacoalition.org/