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February 6, 2006

Media Inquiries:
Kim Rawlings, 301-827-6242
Consumer Inquiries:


FDA's FY 2007 Budget Request Highlights Mission Priorities and Fiscal Responsibility

The Food and Drug Administration (FDA) today released its Fiscal Year (FY) 2007 budget request to Congress totaling $1.95 billion, a 3.8 percent increase over FY 2006.

The FY07 request, which covers the period of October 1, 2006 to September 30, 2007, includes $1.55 billion in budget authority and $402 million in industry user fees. The budget request reflects FDA's resolve to advance its most critical public health initiatives within the constraints of the current budget environment. Carefully developed to safeguard the health of Americans, the FDA agenda for the next fiscal year is designed to fulfill the agency's foremost responsibilities and advance the Administration’s public health goals and priorities.

"I am pleased to present this budget proposal to Congress," said Dr. Andrew C. von Eschenbach, the FDA's Acting Commissioner of Food and Drugs. "Our request supports the President and Secretary Mike Leavitt’s priorities. It is fiscally responsible and it strengthens the FDA's vital mission of advancing medical and other health-promoting products while protecting the public from such persistent and emerging risks as food borne illnesses, chronic diseases, pandemic flu, and bioterrorism."

The proposed increase of $70.8 million over the current budget will enable FDA to focus its staff and resources on priority initiatives, including:

  • Preparedness for the potential threat of pandemic influenza
  • Protection of the food supply from bioterrorism
  • Diverse initiatives to realize the promise of molecular medicine
  • Strengthening the safety of drugs and human tissues for transplantation
  • Meeting statutory obligations under the animal drug and medical devices user fee

The following are FDA's key proposed budget increases:

Pandemic Preparedness ($30,490,000): To protect the nation against the threat of pandemic flu, the FDA proposes intensifying ongoing preparedness activities and launching additional measures to safeguard the public health from this potential threat. Preparedness activities include the development of viral reference strains that manufacturers require to produce influenza vaccines; acceleration of manufacturing capability to produce and deliver sufficient quantities of safe and effective vaccines; collaboration with the international public health community on recognizing and responding to emerging pandemic threats; and the development of measures to address the potential pandemic-related impacts on FDA-regulated food and animal feed.

Critical Path ($5,940,000): The FDA proposes funding for its Critical Path for Personalized Medicine Initiative, a major, nation-wide project designed to make personalized medicine a reality and to translate discoveries in medical science into safe and effective new medical treatments. This is the first time Critical Path funding has been included in the Administration's proposed budget. The Critical Path Initiative will seek to mitigate or eliminate obstacles to the medical product development that impede the ability to transform investments in basic medical research into products that benefit patients’ health.

Food Defense ($19,873,000): The FDA will expand the network of laboratories that would rapidly and competently analyze samples in the event of a terrorist attack on our nation’s food supply. This cooperative effort, which involves States and several federal agencies, will substantially enhance the FDA’s capacity to detect and effectively respond to intentional contamination of our food. As part of this effort, the FDA will also expand its program of targeted food defense research.

Medical Product Safety ($6,435,000): To improve patient safety, FDA proposes significant new investments in the agency's safety programs for human drugs and transplantable human tissues. The FDA seeks $3,960,000 to strengthen its capacity to recognize and act on emerging drug safety issues by modernizing its adverse drug event information systems and broaden the sources of data the agency analyzes for drug safety signals. To increase the safety and effectiveness of human tissue transplants, which are involved in more than a million procedures a year, the FDA is requesting $2,475,000 for its new risk-based program to detect, analyze, and respond to actual or potential disease transmission involving human tissues.

Cost of Living Pay Increase ($20,267,000): The FDA is responsible for protecting the nation against the numerous known and emerging public health hazards; ensuring that the FDA-regulated food for the family table is safe and wholesome; that new human and animal drugs, vaccines, and medical devices are available in a timely manner with demonstrated benefits that outweigh risks; and that equipment that emits radiation and cosmetics do no harm. The agency could not carry out this critical and demanding mission without a highly trained staff of scientists, health care professionals, and support personnel whose salaries make up more than 60 percent of its budget.

User Fee "Triggers" ($7,425,000): The FDA is requesting resources to meet statutory requirements, called “triggers.” This will enable the agency to continue collecting user fees under the Medical Device User Fee and Modernization Act (MDUFMA) and Animal Drugs User Fee Act (ADUFA). These acts require a minimum level of federal spending for reviewing medical devices, and animal drugs and feed as a condition for the agency’s collecting user fees from manufacturers. These additional resources have greatly strengthened the agency’s ability to accelerate the review and approval of these products.

Other User Fee Increases ($20,170,000): The budget request includes user fee increases statutorily prescribed under the Prescription Drug User Fee Act (PDUFA) ($15,268,000); MDUFMA ($3,426,000); ADUFA ($286,000); Mammography Quality Standards Act ($349,000); and for drugs and devices export certification ($661,000) and color certification ($180,000). These user fees support the Administration’s vision of transforming health care and improving access to FDA-regulated products through enhanced agency performance. Since 1993, when the first prescription drug user fees went into effect, they have enabled the agency to significantly reduce the time needed for product reviews and to upgrade other activities, principally by hiring additional staff and acquiring essential information technology.

New User Fees ($25,536,000): In addition, the FDA is proposing two new sets of mandatory user fees. The first, estimated at $22,000,000, would pay the full cost of reinspection and other FDA follow-up work after the manufacturer fails to meet such major FDA requirements as Good Manufacturing Practices, which ensure high quality standards in regulated products. These reinspection and laboratory analyses, which are currently funded by the agency, are essential to verify the manufacturer’s corrective measures. The second new user fee, estimated at $3,536,000, would cover the cost of issuing an estimated 37,000 food and animal feed export certificates.

The FDA's budget request for FY 2007 is future-oriented, a characteristic reflecting the agency's performance strategy since its founding 100 years ago. As it is preparing to enter its second century of service to the nation, the FDA will intensify its efforts that have made it the world’s premier regulatory agency, and an accomplished and steadfast protector of the nation’s health.


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