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FY 2006 Budget in Brief
Food and Drug Administration
The Food and Drug Administration protects the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA also advances the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve health.
The FY 2006 budget request for the Food and Drug Administration (FDA) is $1.9 billion, a program level increase of $81 million over FY 2005 and $614 million over FY 2001. Of the funds requested, the budget proposes $1.5 billion in budget authority, while $381 million will be derived from industry-specific user fees. Significant increases are included to secure our nation's food supply from the risks of contamination and for the Office of Drug Safety to ensure the safety and effectiveness of approved drugs already on the market. The budget also supports increased funding for the premarket review of medical devices as well as drugs and biologics, while continuing to provide funding for the FDA consolidation at White Oak and restoring FDA-wide facilities repair funds.
Since 9/11, FDA has strengthened the nation's defenses against the risk of deliberate contamination of our food supply. Approximately 80 percent of our country's food is under FDA's direct regulatory oversight, and the agency has committed substantial effort and resources to combat threats prior to the occurrence of a terrorist event.
In FY 2006, FDA will continue to ensure consumers are protected against intentional and accidental risks that threaten our food supply. Within the FY 2006 budget, the Foods program requests a total of $522 million, a $28 million increase over FY 2005 devoted to food defense. The Animal Drugs and Feeds program protects the health and safety of all food producing, companion, or other non-food animals; and assures that food from animals is safe for human consumption. This program is responsible for ensuring the availability of safe and effective veterinary drugs and has the primary role in Bovine Spongiform Encephalopathy (BSE) or "Mad Cow" disease prevention efforts. The budget includes $118 million in the Animal Drugs and Feeds program, a $3 million increase over FY 2005.
Food Defense: The FY 2006 budget requests a $30 million increase over FY 2005, for a total of $180 million devoted to protecting the American people against attacks on the national food supply. This request is a part of a continuing effort with the Department of Agriculture (USDA) and the Department of Homeland Security (DHS) to coordinate all strategies used to combat the threat of intentional food contamination. Within the increase, $20 million will be directed to enhance the laboratory surge capacity and national coverage of the Food Emergency Response Network (FERN). FERN is a nationwide network of Federal and State laboratories dedicated to testing for biological, chemical and radiological threat agents. While FDA and USDA are building FERN surge capacity, the agency will continue work with DHS to award new funds to existing State labs in geographic regions with the greatest need according to current threat assessments. The budget request will dramatically increase FDA's ability to rapidly test threat agents and respond to terrorist attacks.
In addition to laboratory preparedness, $6 million of this request will fund research based on food vulnerability threat assessments developed in collaboration with USDA. This research will focus on closing mission-critical knowledge gaps in food defense through development of technologies able to detect and prevent threats to the food supply. FDA will continue its support of the government-wide biosurveillance effort with a $3 million increase, for a total of $5 million dedicated to providing the earliest possible detection of the intentional release of deadly pathogens into food, water, or the environment. This increase will help coordinate existing food surveillance capabilities with public health and environmental officials at the State and national levels under a unified system. Finally, $1 million of the request will be used for central response coordination through the Office of Crisis Management.
Animal Drugs Premarket Review: The budget includes $11 million derived from industry-specific fees, an increase of $3 million over FY 2005. These funds will allow FDA to improve review times on 90 percent of original new animal drug applications by 40 days, while maintaining the safety of approved animal drugs.
In FY 2006, the budget includes $747 million for the Human Drugs and Biologics, an increase of $19 million for the Human Drugs program and an increase of $7 million in the Biologics program. Of the total spending on these activities, $288 million will be from industry-specific user fees. These funds will ensure the safety and efficacy of new and existing human drugs and biologics - helping to make medicines safer, more affordable and more available. All new drugs will be evaluated for safety and efficacy before entering the market, and monitoring efforts will be directed toward the 10,000 drugs that are already on the market to be sure they continue to meet the highest standards of safety and efficacy. In addition, existing and emerging biological products, including whole blood and blood products; vaccines; and therapeutic products, including cells, gene therapies, and tissues will be assessed for safety and effectiveness. In FY 2004, FDA approved 534 new and generic drugs and biological products, many of which represent significant therapeutic advances.
Drug Safety: The budget includes an increase of $6.5 million, including $1.5 million in PDUFA user fees, over FY 2005 for the Office of Drug Safety, for a total of $33 million. This represents a 147 percent increase in funds for this office since FY 2001. With increased resources in FY 2006, FDA plans to hire additional staff to increase personnel dedicated to evaluating and communicating drug safety risks to the healthcare community and the American Public. FDA also plans to use additional staff to establish policies and processes regarding safety reviews and risk management, manage increased drug safety monitoring workload and internal communications, and increase scientific expertise available to explore safety risks and signals in various populations. Further, FDA intends to apply more funding to obtaining access to a wide range of clinical, pharmacy and administrative databases. Given the highly fragmented healthcare system in the United States, there is no single healthcare database that the Agency can rely upon to widely monitor drug adverse events. As each drug has its own indication(s) that may result in its differential use in different populations, it is essential that the Center for Drug Evaluation and Research have access to a wide range of databases to adequately assess drug safety.
FDA will continue its efforts to improve the timeliness and availability of drug safety information and will seek alternative strategies for managing drug safety issues. FDA will also increase the use of external experts in evaluating post-marketing safety issues. The agency's actions will be harmonized with the emerging results of an Institute of Medicine (IOM) Study of the Drug Safety System. The IOM committee conducting this study will examine the role of FDA within the health care delivery system and recommend measures to enhance the confidence of Americans in the safety and effectiveness of their drugs.
Prescription Drug User Fee Act (PDUFA): The budget includes $305 million from the Prescription Drug User Fee Act (PDUFA) fees, of which $279 million is available for the Human Drugs and Biologics programs and the remaining $26 million for costs related to the management and operations of the program. During renegotiation of the PDUFA agreement in 2002, FDA sought and received the statutory authority to expend user fees on postmarket risk management. The PDUFA program has since substantially increased the amount of funds devoted to maintaining the safety standards essential to the public's health. These fees have also enabled the provision of more technical assistance, advice, and rapid responses to special inquiries during the drug development period and after drugs are approved for sale. As a result, industry has been able to shorten the time needed for drug development and continually improve the safety profile of marketed drugs.
The FY 2006 budget includes an increase of $12 million, for a total of $289 million to ensure medical devices are safe and effective. This level of funding is consistent with the intent of the Medical Devices User Fee and Modernization Act of 2002 (MDUFMA), which provides a total of $40 million in industry-specific user fees for devices work across FDA. This request for the Medical Devices program will lead to marked improvement in application review performance while maintaining the consistent quality and safety of approved medical device products. In FY 2006, FDA expects to meet goals stipulating that the agency must review and make decisions on 80 percent of all original premarket medical device applications within 150 and 320 days respectively. These are the most challenging review goals to date, with goals becoming even more ambitious in FY 2007. Additional funding will also be directed towards medical device postmarket safety efforts. MDUFMA fees contribute to the evaluation of postmarket studies required as a condition of medical device approval, and the compilation, development, and review of postmarket information to identify safety and effectiveness issues.
The FY 2006 budget request includes a total of $22 million in resources directed to move and fit out costs for the new FDA consolidated facility the General Services Administration (GSA) is constructing in White Oak, MD. This funding is needed for completion of the project's next phase, which includes the Center for Devices and Radiological Heath (CDRH) Engineering and Physics Laboratory and the data center consolidation. These resources will be directed to relocation costs, including move and fit-out of the CDRH lab and communications and data equipment for the consolidated data center. The FY 2006 GSA budget includes $128 million primarily for construction of the second of two Center for Drug Evaluation and Research buildings to be occupied in FY 2007 and the second phase of construction for the consolidated data center.
Buildings and Facilities:
In FY 2006, the budget seeks $7 million to pay for repair and maintenance for FDA-owned facilities nation-wide. FDA inventory includes approximately 40 buildings in 16 separate locations, plus field offices and newly established BSL-3 laboratories. Funding was paused in FY 2005, as FDA utilized carryover balances from the prior year to pay for facility repair.
In FY 2006, FDA proposes a budget structure change in order to enhance the agency's ability to respond to emerging situations without being hindered in performing mission critical activities. The two major changes are the establishment of a single budget line item for the agency's field inspection and analysis activities (Office of Regulatory Affairs), and changing the display and management of facility rent costs by incorporating rental expenses into program estimates. By making these alterations, the budget will allow greater flexibility in how resources are allocated in response to crisis situations, eliminate the need for many reprogramming requests to Congress, and more accurately portray the cost of operating each program.
FDA will also seek management efficiencies through a $5 million streamlining of information technology efforts and a $1.5 million administrative reduction.
To accomplish this, the agency will spur consolidation of information technology activities and reduce administrative expenses outside the user fee-funded areas. Both of these management improvements support the President's Management Agenda.
Last revised: March 31, 2005
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