HHS FY2015 Budget in Brief
Food and Drug Administration (FDA)
The Food and Drug Administration is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation. FDA also advances the public health by helping to speed innovations that make medicines more effective, safer, and more affordable, and by helping the public get the accurate, sciencebased information they need to use medicines and foods to maintain and improve their health. Furthermore, FDA has responsibility for regulating the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Finally, FDA plays a significant role in the nation’s counterterrorism capability by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
FDA Budget Overview
(Dollars in millions)
|Animal Drugs and Feeds|
|National Center for Toxicological Research|
|Center for Tobacco Products|
|Headquarters and Office of the Commissioner|
|FDA Consolidation at White Oak|
|GSA Rental Payment|
|Other Rent and Rent Related Activities|
|Food and Drug Safety One-Time Resource|
Subtotal, Salaries and Expenses
|Export Certification Fund|
|Color Certification Fund|
|Buildings and Facilities|
Total, Program Level
|Current Law User Fees /2|
|Prescription Drug (PDUFA)|
|Medical Device (MDUFA)|
|Animal Drug (ADUFA)|
|Animal Generic Drug (AGDUFA)|
|Family Smoking Prevention and Tobacco Control Act|
|Generic Drug (GDUFA)|
|Mammography Quality Standards Act (MQSA)|
|Export Certification Fund|
|Color Certification Fund|
|Voluntary Qualified Importer Program|
Subtotal, Current Law User Fees
|Proposed Law User Fees /2|
|Food Facility Registration and Inspection|
|Food Substance Contact Notification|
Subtotal, Proposed Law User Fees
Less Total, User Fee
|Total, Discretionary Budget Authority|
2015 +/- 2014: +1,033
1/ In addition to these resources, section 747 of the Consolidated Appropriations Act, 2014 makes user fees sequestered in FY 2013 available for obligation in FY 2014. The estimate as of September 30, 2013 totals $79 million and will be revised as updated information on FY 2013 collections is available.
2/ The Drug Quality and Security Act (P.L. 113-54) authorized three new FDA user fees: the outsourcing facility fees; the prescription drug wholesale distributer licensing and inspection; and, the third-party logistics provider licensing and inspection fees. It is expected that collections for FY 2015 will be minimal.
The FY 2015 Budget includes $4.7 billion for the Food and Drug Administration (FDA), an increase of $358 million, or 8 percent, above FY 2014. This increase consists of $23 million in budget authority and $335 million in user fees. The FDA budget advances mission critical activities as well as the highest priority public health challenges, such as modernizing the food safety system, ensuring the safety of medical products, advancing medical countermeasures, and continuing implementation of the Tobacco Control Act to reduce tobacco use and initiation as well as encourage the cessation of tobacco use.
Modernizing the Food Safety System
The Food Safety Modernization Act (FSMA) was enacted in 2011 to modernize the food safety system to meet 21st century global challenges. These new authorities enable FDA to focus on preventing outbreaks of foodborne illness and other food related hazards to improve the public’s health, reduce medical costs, and avoid interruptions to the nation’s food supply. Three years after the enactment of FSMA, FDA has issued required regulations, conducted stakeholder outreach, and increased capacity to support a prevention-based and integrated food safety system. FDA also created the Coordinated Outbreak Response and Evaluation (CORE) network which improves the efficiency of FDA programs, in coordination with federal and state partners, including CDC and the Department of Agriculture, to respond to and manage human and animal foodborne illness outbreaks. For example, in 2013, the network aided the response and investigation into a multi-state outbreak of E. coli infection which resulted in the recall of the contaminated produce that caused the outbreak. Through the CORE network, FDA was able to provide a faster and more coordinated agency-wide response to this incident.
The FY 2015 Budget includes a total program level of $1.5 billion, $263 million above FY 2014, for FDA to build and expand on current food safety activities. With increased budget authority, in FY 2015 FDA will focus on five main activities including
rulemaking and guidance development to support regulatory action;
technical support to ensure safety standards are effective and efficient;
food safety regulatory training and capacity among stakeholders and partners, including federal, state, local, tribal and international entities;
risk analysis to support priority setting; and,
research to better understand the impact of antimicrobial resistance on public health.
CDC estimates that 48 million foodborne illnesses occur each year from contaminated foods. The FY 2015 total for food safety at FDA includes $229 million from the food import fee and the food facility registration and inspection fee. These proposed additional revenues are vital to funding the key FSMA activities planned for FY 2015, including enhancing food facility inspection capacity and admissibility review of food and fee imports. This increase is especially critical as FDA continues to regulate about 76 percent, more than $702 billion, of the food supply in the United States of which a growing proportion, approximately 15 percent overall and significantly more for specific products such as seafood, is imported from other countries. These resources will enable FDA to invest upfront in building the regulatory framework needed to realize the vision of FSMA.
The Budget also proposes a $5 million food contact notification user fee to better position FDA to reduce microbial food contamination through premarket notification to ensure the safety of food contact substances. In addition, currently authorized fees such as the voluntary qualified importer program, export certification, and the food reinspection and recall fees will continue to support agency-wide food safety activities. These current fees enable FDA to expedite processes such as the timely assessment of color additives used in foods, drugs, and cosmetics, and approval of certifications to facilitate international trade.
Enhancing Medical Product Safety
FDA oversees the safety, effectiveness, availability, and quality of an extensive range of regulated products available to Americans, which encompasses prescription and over-the-counter drugs; biologics including vaccines, blood products, and gene therapies; animal drugs; and, medical devices ranging from bandages to laser surgical equipment and radiation emitting products. FDA also ensures that regulated products are marketed according to federal standards and that products available to the public continue to be safe especially as new clinical information becomes available. The FY 2015 Budget includes a program level of $2.6 billion, $61 million above FY 2014, to continue core medical product safety activities across FDA. In order to address challenges with human drugs personalized for individual patient needs, known as compounding, the Budget includes $25 million for a new agencywide initiative to expand and improve oversight of drug compounding to ensure that such products available to Americans are safe and effective. This initiative, along with clarity provided in the Drug Quality and Security Act, will position FDA to prevent events such as the multi-state outbreak of fungal meningitis in 2012 among patients who received contaminated steroid injections from a compounding center in New England. FDA will establish a more comprehensive system for drug safety. In particular, these resources will support three primary activities:
Inspections and Enforcement: FDA will continue reactive inspections, ensure compliance with corrective actions, and conduct additional new proactive inspections of higher risk pharmacies.
Policy Development: FDA will develop required regulations and guidances to oversee compounding pharmacies.
State Collaboration and Coordination: FDA will strengthen coordination and communication with states to improve oversight, as well as investing in training state inspectors to improve facility compliance with FDA standards.
In 2013, FDA worked with a network of partners to help prevent 170 drug shortages to ensure the continued supply of products including lifesaving medicines. Of the total $2.6 billion for medical product programs, $1.3 billion is in budget authority to fund the highest priority drugs, biologics, and device activities in FY 2015 including applied research, domestic and foreign facility inspections, and pre and post market surveillance to ensure the products available to Americans are timely, safe, and effective. FDA will continue to implement key new responsibilities authorized in the FDA Safety and Innovation Act and the Drug Quality and Security Act.
In addition, FDA continues to work toward meeting performance goals and commitments associated with all user fees, especially the newer human generic drugs and biosimilar biological products programs. FDA is also working to implement new fees authorized in the Drug Quality and Security Act to support new provisions associated with drug safety.
Reducing the Use and Harms of Tobacco
Tobacco remains the leading preventable cause of disease, disability, and death in the United States. The FY 2015 Budget includes $566 million in user fees, an increase of $32 million over FY 2014, for the FDA Center for Tobacco Products, the Office of Regulatory Affairs tobacco field programs, and related activities. These resources will be used to continue implementation of the Family Smoking Prevention and Tobacco Control Act by focusing on the following three strategic objectives:
Reducing initiation of tobacco product use;
Decreasing the harms of tobacco products; and,
Encouraging cessation among tobacco users.
FDA carries out these responsibilities by regulating the manufacturing, marketing, and distribution of tobacco products and through other public health initiatives.
In FY 2015, FDA will expand the Tobacco Retail Inspection program, which awards contracts to states and territories to conduct compliance inspections of tobacco product retail establishments; advertising and labeling activities to ensure the public does not receive deceptive information; enforcement activities including monitoring compliance with registration requirements; and research to better understand risks and potential harms of tobacco products. In addition, FDA will also continue training and educational activities for tobacco manufacturers and retailers to ensure compliance and awareness, outreach efforts to educate the public about the harms of tobacco products, inspection activities, and criminal and civil investigations. Activities will build on recent accomplishments such as the campaign launched in February 2014 to reduce tobacco use in youth.
Advancing Medical Countermeasures
The FDA Medical Countermeasure Initiative ensures the nation has countermeasures in place to protect against chemical, biological, radiological, and nuclear threats, as well as emerging infectious disease threats. The FY 2015 Budget includes $25 million for this initiative, the same as in FY 2014. These resources will help accelerate development, evaluation and approval, and establish a clear regulatory, legal, and policy framework to support emergency preparedness and response.
The Budget proposes five new user fees across FDA and reflects scheduled increases in currently authorized user fees. Resources from these user fees are critical to enable FDA to carry out its mission. The Budget includes the proposed fees described in the narratives above as well as well as two additional user fees proposed for FY 2015. The Budget continues to propose the international courier user fee, which would provide $6 million to support the activities related to the increased volume of FDAregulated commodities, predominantly medical products, imported through express courier hubs. In addition, the proposed cosmetic user fee totaling $19 million will support FDA’s role in ensuring the safety of cosmetic products in the United States as the volume of both domestic and imported cosmetic products continues to grow and manufacturing technology and ingredients become more complex. FDA will be in the process of establishing new fee programs in FY 2015 to begin collecting revenues authorized under the Drug Quality and Security Act.
FDA Infrastructure and Facilities
The FY 2015 Budget focuses resources on the highest priority infrastructure demands to ensure that FDA facilities have the capacity to support the agency’s broad and growing authorities as well as keep up with the modern economy. The amounts in the Budget reflect the current estimates of what is needed to continue efforts to consolidate FDA programs to the White Oak campus in Maryland based on the construction timeline. The Budget will support activities associated with the move of over 2,000 federal staff to the White Oak campus beginning in FY 2014 where they will have access to the stateofthe-art Life Sciences-Biodefense Complex in addition to other campus facilities.
In addition, the Budget provides $9 million, the same as FY 2014, to fund repair and maintenance of FDAowned facilities. Resources will be used for repairs at the Jefferson Laboratories Complex in Arkansas, which houses activities conducted by the National Center for Toxicological Research and other FDA field efforts.