Fiscal Year 2010 Budget in Brief

Food and Drug Administration

(dollars in millions)

The FDA is responsible for protecting 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 is also responsible for advancing 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 their health.

The FY 2010 Budget requests over $3.2 billion for the Food and Drug Administration (FDA), a net program level increase of $511 million over FY 2009. This is the largest increase ever requested for FDA. The FDA budget includes increased investments to improve the safety of the Nation’s food supply, drugs, and other medical products, accelerate the availability of new and innovative medical products and provide Americans access to more affordable drugs.

ENHANCING THE SAFETY OF THE NATION’S FOOD SUPPLY

The FDA plays a critical role in helping to ensure that the food we eat is safe and does not cause harm. Because of this, the United States has one of the safest food supply chains in the world. In recent years, there have been a number of problems with the food that has made its way to our kitchen tables, including outbreaks of salmonella caused by contaminated peppers and peanut butter products. These recent problems underscore the challenges the Nation faces in food safety.

The Administration recognizes these challenges and is working with State, local, and international food safety partners, and with industry and consumers to increase focus on prevention and improve oversight and enforcement. The FY 2010 President’s Budget includes over $1 billion for food safety, a $259 million increase over the FY 2009 level, including $75 million in new user fees for food inspection and food facility registration and $19 million for reinspection and export certification. This user fee will provide funding for increased inspections and help to defray costs related to ensuring compliance by food facility establishments. With these increased resources, FDA will be able to expand on investments in strategic prevention, intervention and response to reduce unintentional and intentional contamination of FDA-regulated food in foreign and domestic commerce at all points in the supply chain. FDA will expand its overseas presence, import review and analysis, laboratory analysis and output capacity, and upgrade IT systems to achieve a modern bioinformatics and information management platform. FDA will expand domestic surveillance activities, and strengthen its ability to support State food safety inspections. FDA will increase the number of food inspectors by approximately 20 percent in FY 2010.

IMPROVING THE SAFETY AND REVIEW OF MEDICAL PRODUCTS

FDA is a leading regulatory agency for review of medical products in the world. Because of FDA, Americans have access to thousands of drugs and devices that are safe and effective for their intended uses, treating everything from seasonal allergies to advanced cancer. The FY 2010 President’s Budget includes an increase of $166 million above FY 2009 to enhance the safety oversight of medical products. The increases will support a life-cycle approach to safety, which starts at product development and pre-approval testing, through approval, and post approval safety surveillance. The additional funding also provides for increased inspections to improve the security of the supply chain, and supports implementation of requirements included in the FDA Amendments Act.

The Administration is committed to promoting the development of new products to treat life-threatening conditions, and lowering the cost of drugs for all Americans. In total, the FY 2010 Budget request will provide an investment of over $1.2 billion for medical product safety.

LOWERING THE COST OF DRUGS FOR AMERICANS

Prescription drug costs are high and rising, causing many Americans to split pills, skip doses or not take needed medication altogether. The FY 2010 Budget request includes three proposals to lower the cost of drugs for all Americans.

Generic Biologics: The Administration will accelerate access to make affordable generic biologic drugs available through the establishment of a workable regulatory, scientific, and legal pathway for generic versions of biologic drugs. In order to retain incentives for research and development for the innovation of breakthrough products, a period of exclusivity would be guaranteed for the original innovator product, which is generally consistent with the principles in the Hatch Waxman law for traditional products. Additionally, brand biologic manufacturers would be prohibited from reformulating existing products into new products to restart the exclusivity process, a process known as “ever greening.”

Drug Importation: The FY 2010 President’s Budget includes a proposal to allow Americans to buy safe and effective drugs from other countries. The Budget request includes $5 million to allow FDA to begin working with the various stakeholders to develop policy options related to drug importation. In addition, the Administration will work with Congress to enact authorizing legislation to support the infrastructure required to ensure the safety of these medicines.

Generic Drug Review: Increasing access to safe and affordable generic drugs is a priority at the FDA. The FY 2010 President’s Budget proposes $36 million for a new industry-funded generic drug user fee, which will aid in lowering drug costs by bringing more generics to market. These additional resources will help to make drugs safer, more affordable and more readily available.

IMPROVING SAFETY AND COMPLIANCE THROUGH USER FEES

In addition to the proposed generic drug user fee and the food inspection and food facility registration user fee, which are mentioned above, the FY 2010 Budget request proposes the Reinspection User Fee and the Export Certification User Fee for food and animal feeds. The proposed Reinspection User Fee of $26 million requires manufacturers and laboratories to pay the full costs of reinspections and associated follow-up work due to their failure to meet FDA requirements during an inspection. This proposal rewards firms for complying with health and safety standards while ensuring that companies are charged the costs of reinspection when they fail to meet FDA safety and quality regulations.

The second user fee, export certification for food and animal feeds, 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 issued by FDA enhance the global competitiveness of American food and animal feed producers by ensuring that the products meet regulatory requirements. With this expansion, the food and animal feed industry will no longer receive preferential treatment through government funding of export certificates.

SUPPORTING FDA FACILITIES

The FY 2010 Budget requests $39 million in budget authority for headquarters consolidation at the new FDA campus in White Oak, Maryland. These resources will enable FDA to continue to transition to the newly consolidated facility under construction by the General Services Administration (GSA). At White Oak, FDA operates in modern laboratories and facilities equipped with the latest technologies and tools that allow FDA scientists and health professionals to execute their mission-critical responsibilities. The White Oak Campus replaces existing fragmented facilities with state-of-the-art laboratories and program support facilities. The Budget also requests an increase of $14 million for GSA rental payments and other rent and rent related costs. In FY 2010, the budget provides $12 million to pay for necessary repair and maintenance of FDA-owned facilities nationwide.

FY 2010 Budget in Brief Home