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FY 2007 Budget in BriefFood and Drug AdministrationOn this page:
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. Food and Drug AdministrationThe FY 2007 budget request for the Food and Drug Administration (FDA) is $1.9 billion, a net program level increase of $71 million over FY 2006. FDA’s budget includes significant increases totaling $126 million to protect the Nation against the threat of an influenza pandemic, ensure the safety and security of our food supply, capitalize on breakthroughs in basic research through the Critical Path to Personalized Medicine Initiative, increase safety of drugs already on the market, and accelerate the availability of new and innovative medical products. These increases are partially offset by $55 million in management and administrative savings. The budget also supports human tissue safety efforts, FDA’s consolidation efforts at White Oak, Maryland, and salary and rent costs. Pandemic Influenza PreparednessDuring the past year, the Administration and Congress have acted decisively to build our Nation’s defenses against the possibility of an influenza pandemic. Through the National Strategy for Pandemic Influenza, HHS and its Federal partners have advanced a comprehensive plan to prepare, detect, and respond in the event of an outbreak. The FY 2006 Defense Appropriations Act provided FDA with $20 million to enhance the regulatory science base to work with the private sector to manufacture influenza vaccines. This supplemental funding augments FDA base resources for an FY 2006 total of $25 million in pandemic influenza activities. In FY 2007, FDA will continue to play a vital role in the plan as the Nation achieves greater preparedness for this threat. The FY 2007 President’s Budget requests a total of $55 million for pandemic influenza preparedness, a $30 million increase over FY 2006. The FY 2007 budget includes $15 million in increased funding to accelerate production capabilities for vaccine candidates and for the development of pandemic influenza virus strains used in manufacturing the vaccine in a collaborative effort with CDC. The budget also includes $15 million to safeguard the Nation’s food supply and detect and contain animal outbreaks in the event of domestic outbreak. These activities will include improved surveillance systems for poultry and other foods and research on methods and tools to detect and contain transmission of possible foodborne influenza viruses. These investments are consistent with the HHS Pandemic Influenza Plan and will better secure our Nation against the threat of a pandemic outbreak. Protecting the Food SupplyAs greater understanding is gained of the many natural and man-made threats that face our Nation’s security and safety, continued vigilance is needed to protect our citizens from a threat that is widely known – Bioterrorism. Since 9/11, FDA has made great strides in strengthening the Nation’s defenses against the risk of contamination of our food supply. FDA is continuing to implement drastic changes in its oversight of imported foods. FDA has implemented new authority for food facility registration and for recordkeeping and administrative detention of suspected foods. The Prior Notice Center is expecting to process up to 20,000 prior notifications for food import shipments per day; greatly increasing the surveillance of imported foods. However, the threat of deliberate contamination of our food is a constant one. The FY 2007 President’s Budget requests a total of $450 million for the Foods program. Within this total, $178 million is devoted to protecting the American people against attacks on the national food supply, a $20 million increase over FY 2006. 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, $13 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 significantly increase FDA’s ability to rapidly test threat agents and respond to terrorist attacks. In addition to laboratory preparedness, this increase will also support field staff that are on the front lines of the battle to protect our food supply. The budget directs $3 million to fund food defense personnel and operations in the Office of Regulatory Affairs. FDA will also continue its support of the government-wide biosurveillance effort. The FY 2007 budget requests a $2 million increase, for a total of $5 million in biosurveillance activities to provide 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 professionals at the State and national levels, under a unified system. The request also includes a $1 million increase used for central response coordination through the Office of Crisis Management. Finally, $1 million will fund research based on food vulnerablility threat assessments developed in collaboration with USDA. This research will focus on closing mission-critical knowledge gaps in food defense by developing technologies to detect and prevent threats to the food supply. Human Drugs and BiologicsIn FY 2007, the budget includes $745 million for the Human Drugs and Biologics programs, an increase of $17 million for the Human Drugs program and an increase of $15 million for the Biologics program over FY 2006. Of the total funding for these activities, $289 million will be from industry-specific user fees. These funds will ensure the safety and efficacy of existing human drugs and biologics – helping to make medicines safer, more affordable, and more available. FDA evaluates all new drugs for safety and efficacy before they enter the market. FDA also monitors 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, FDA assesses the safety and effectiveness of existing and emerging biological products (including whole blood and blood products), vaccines, and therapeutic products, including cells, gene therapies, and tissues. In FY 2005 FDA approved 593 new and generic drug products and new biological products, resulting in significant therapeutic advances, many new products on the market, and many new treatment uses for existing products. Critical Path to Personalized Medicine: FDA needs to take advantage of enormous breakthroughs in basic research and facilities enabling medical products to be developed faster, safer, and at less expense. The budget includes $6 million in targeted investment in the critical path to personalized medicine, which will pave the way to more efficient, less expensive clinical trials and safer, more effective drugs for the American public. This will enable FDA to approve prescription drugs for individual groups of people, rather than drugs to treat whole populations. By approving drugs tailored to the individual molecular traits unique to individuals, health professionals will be able to prescribe safer, more effective medical products for every American. Drug Safety: The budget includes an increase of $4 million for work on improving the safety of drugs on the market, for a total of $39 million in the Office of Drug Safety. With increased resources in FY 2007, FDA plans to modernize the Adverse Event Reporting System (AERS) and establish “AERS II” as the primary source for drug product adverse event data. These resources will also allow FDA to augment AERS data and further its efforts with the Centers for Medicaid and Medicare Services (CMS) to obtain access to valuable drug safety information housed in CMS population-based databases. This collaboration with CMS will be integrated with the Sentinel System, a seamless platform for gathering and evaluating information about adverse events related to the use of medical products. This integration will enable FDA to gather more information from the point of care about potential safety problems and will provide a framework for turning this raw data into useful knowledge about the safe use of medical products. Through this modernization, FDA will continue to ensure that the medical products it regulates are the safest in the world. Tissue Safety: One of FDA’s top priorities is to enhance patient protection by ensuring the safety of medical products, which include human cells, tissues, and cellular and tissue-based products (HCT/P’s). Advances in medical science have resulted in a tremendous increase in transplants and other uses of HCT/P’s. The number of transplants has grown to about 1 million per year in the U.S. To support a new risk-based approach for tissue regulation, the FY 2007 budget requests a $2 million increase to ensure the safety of tissues. This increase will allow FDA to increase staffing levels for critical functions at the Center for Biologic Evaluation and Research, and in the field. Funding would increase inspections of facilities by 30 percent. User Fee ProgramsNew User Fee Proposals: The FY 2007 President’s Budget proposes two new user fee programs. The first proposal is a $22 million user fee program requiring manufacturers and laboratories to pay the full costs of reinspections and associated followup work due to their failure to meet FDA requirements during an inspection. This new proposal rewards firms for complying with health and safety standards while ensuring that companies are charged with the costs of reinspection when they fail to meet FDA safety and quality regulations. The budget also proposes to expand the current drug, animal drug, and medical device export certification user fee program by $4 million to also include food and animal feed. Export certificates may be requested by firms seeking documentation that exported products are in compliance with U.S. laws and regulations, importing countries’ requirements, and certain national or international standards. These certificates enhance the global competitiveness of American food and animal feed producers by ensuring that the products meet specific legal requirements. With this expansion, the food and animal feed industry will no longer receive preferential treatment through government payment of export certificates. Medical Device and Animal Drug Review: The FY 2007 budget includes an increase of $11 million, for a total of $272 million, to ensure medical devices are safe and effective and an increase of $6 million, for a total of $105 million, to ensure the safety and efficacy of animal drugs. These funding levels are consistent with the intent of the Medical Devices User Fee and Modernization Act of 2002 as modified by the Medical Device User Fee and Stabilization Act in 2005; and the Animal Drug User Fee Act. Both of these user fee programs are vital to maintaining the efficiency of FDA’s review enterprise while continuing to uphold the stalwart safety record of FDA approved products. The FDA budget requests an additional $5 million for medical device review that will lead to marked improvement in application review time while maintaining the consistent quality and safety of approved medical device products. New and increasingly complex medical devices are making astonishing medical advances possible in both diagnosis and treatment. Through additional user fee resources, FDA will be able to review medical device applications for safety and effectiveness in a manner that will move products to the market quickly. In FY 2007, FDA expects to meet goals stipulating that the Agency review and make decisions on 90 percent of all original premarket medical device applications within 180 and 320 days respectively. The budget also requests an increase of $2 million for the process of reviewing new animal drug applications. The Animal Drugs User Fee program provides FDA with the ability to provide quality premarket reviews in a cost-efficient and timely manner. These funds will allow FDA to review 90 percent of original new animal drug applications within 200 days. FacilitiesHeadquarters Consolidation: The FY 2007 budget request includes a budget authority increase of $4 million for a total of $26 million for headquarters consolidation at White Oak, MD. In addition to this budget authority, FDA will expend $8 million in Prescription Drug User Fee program carryover resources to bring total FY 2007 White Oak resources to $34.5 million. These new resources will be directed to move and 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 design and additional costs for the Center for Drug Evaluation and Research Office Building II and the second phase of the Central Shared Data Center. The FY 2007 GSA budget includes $179 million primarily for construction of the Center for Devices and Radiological Health high bay laboratory, the Office of Regulatory Affairs and Office of the Commissioner office complex, and infrastructure costs. Buildings and Facilities: In FY 2007, the budget seeks $5 million, a decrease of $3 million from FY 2006, to pay for repair and maintenance of FDA-owned facilities nationwide. Resources will fund safety improvements at the National Center for Toxicological Research and food safety laboratories. The request is decreased due to a delay of specific lower priority renovations to regional laboratories. Strategic RedeploymentThe current budget environment requires that every agency, including FDA, closely examine its current expenditures to determine where it can find savings. In FY 2007, FDA is proposing $52 million in strategic redeployment and personnel efficiencies agency-wide . FDA has conducted a risk-based analysis to identify resources that will be redeployed in lower priority public health functions in order to fund the higher priority initiatives that yield the greatest public health benefit. This agency-wide strategic redeployment will allow FDA to conduct priority public health activities at the least cost to the American public. One of FDA's many food defense activities, the Prior Notice Center (PNC) identifies imported food and feed products that may be intentionally contaminated with biological, chemical, or radiological agents, or which may pose significant health risks to the American public. Once identified, the PNC takes action to keep these products from entering into the U.S. In FY 2005, FDA exceeded its prior notice performance target of 38,000 reviews, by conducting 86,187 import security reviews. FDA collaborated with Customs and Border Protection to direct field personnel to hold and examine five suspect shipments of imported food; refused 141 lines of food for prior notice violations; and conducted 86,187 intensive security reviews of Prior Notice submissions out of 8,705,847. In FY 2007, FDA expects to continue to conduct import security reviews of products that may pose significant health risks to the American public. |
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Last revised: February 20, 2006
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