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 affordable; and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. Furthermore, FDA has responsibility for regulating the manufacturing, 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)
|FDA Programs /2||2016||2017 /1||2018/5||2018 +/- 2017|
|Animal Drugs and Feeds||189||191||183||-7|
|National Center for Toxicological Research||63||63||60||-3|
|Headquarters and Office of the Commissioner||300||291||322||+31|
|White Oak Consolidation||52||52||57||+5|
|GSA Rental Payment||224||236||250||+14|
|Other Rent and Rent Related Activities||120||116||133||+17|
|Subtotal, Salaries and Expenses||4,716||4,609||5,021||+411|
|Export Certification Fund||5||5||9||+4|
|Color Certification Fund||9||10||10||+0|
|Rare Pediatric Priority Review Vouchers||8||8||8||--|
|Buildings and Facilities||9||9||9||--|
|21st Century Cures Act||--||20||60||+40|
|Total, Program Level||4,745||4,660||5,116||+456|
|Current Law User Fees /3||2016||2017||2018||2018 +/- 2017|
|Prescription Drug /4||851||755||1,262||+508|
|Medical Device /4||138||126||439||+313|
|Animal Drug /4||23||24||70||+47|
|Animal Generic Drug /4||10||11||18||+7|
|Family Smoking Prevention and Tobacco Control Act||599||598||672||+74|
|Generic Drug /4||318||323||616||+293|
|Mammography Quality Standards Act||20||21||21||--|
|Export Certification Fund||5||5||5||--|
|Color Certification Fund||9||10||10||+0|
|Rare Pediatric Priority Review Vouchers||8||8||8||--|
|Voluntary Qualified Importer Program||5||5||5||--|
|Third Party Auditor Program||1||1||1||--|
|Subtotal, Current Law User Fees||2,017||1,917||3,223||+1,306|
|Proposed Law User Fees||2016||2017||2018||2018 +/- 2017|
|Export Certification /6||--||--||4||+4|
|Subtotal, Proposed Law User Fees||--||--||4||+4|
|Less Total, User Fee||2,017||1,917||3,228||1,311|
|Total, Discretionary Budget Authority||2,728||2,743||1,888||-854|
|FDA Totals||2016||2017||2018||2018 +/- 2017|
1/ Reflects the annualized level of the Continuing Resolution that ended April 28, 2017, including the across the board reduction, the 21st Century Cures Act, and directed transfers.
2/ Reflects a transfer of $1.5 million to the HHS Office of Inspector General for FDA oversight activities as specified in the FY 2016 appropriation and continued by the FY 2017 Continuing Resolution less a rescission.
3/ Does not reflect priority review voucher user fee for Medical Countermeasures as FDA continues to develop an estimated fee level.
4/ The prescription and generic drug, biosimilar, and medical device user fee programs expire on October 1, 2017. The Budget includes legislative proposals to reauthorize these four user fee programs. The Budget also includes legislative proposals to increase fees for the animal drug and animal generic drug user fee programs in their fifth and final year of authorization.
5/ All figures are displayed comparable to the FY 2018 President’s Budget. The FY 2016, FY 2017, and FY 2018 columns have been updated to reflect reallocated funding across the programs addressing previous reorganizations that consolidated economists in Headquarters and established the Oncology Center of Excellence, as well as to better aligning the funding structure to services related to intergovernmental affairs.
6/ The FY 2018 President’s Budget proposes to increase the statutory user fee limit for export certification.
The Food and Drug Administration (FDA) protects and advances public health through an array of programs and activities, ranging from minimizing occurrences of drug shortages to carrying out inspections of imported food products. FDA estimates that Americans currently pay approximately two cents per day to ensure that the products it regulates—which account for more than 20 percent of every consumer dollar spent on products in the United States—are safe and effective. The Fiscal Year (FY) 2018 Budget includes $5.1 billion in total resources for FDA—an increase of $456 million or 10 percent above the FY 2017 Continuing Resolution. At this total level, the Budget provides an increase of $1.3 billion in user fees, while reducing budget authority by $854 million. With the proposals in this budget, the burden on American taxpayers will be even lower—a little over one cent per American per day.
The Budget prioritizes resources across core public health activities including advancing the development and approval of safe and effective medical products, supporting the continued transformation of the food safety system, supporting the Department’s preparedness enterprise, and conducting innovative research.
Advancing Access to Safe and Effective Medical Products
FDA’s Center for Drug Evaluation and Research approved 22 novel drugs in calendar year 2016. Approvals included the first treatment for patients with spinal muscular atrophy, a new drug to treat patients with a rare chronic liver disease known as primary biliary cirrhosis, and two new treatments for patients with hepatitis C. Additionally, 2016 marked the highest number of generic drug approvals and tentative approvals—more than 800—in the history of FDA’s generic drug program. Many of these approvals were for first-time generic drugs, with the introduction of a generic counterpart for a brand-name product for which there was previously no generic.
FDA not only makes available safe and effective medical products, but also takes great efforts—within its legal authority—to address and prevent drug shortages. Drug shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. FDA works closely with manufacturers of drugs in short supply to communicate the issue and to help restore availability. FDA also works with other firms who manufacturer the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage. In 2016, FDA prevented 115 drug shortages.
These examples reflect only a few of the many medical product responsibilities FDA carries out. FDA oversees the safety, effectiveness, availability, and quality of an extensive range of regulated products available to Americans, which encompass 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. Across the vast jurisdiction of FDA-regulated products and activities, FDA continues to incorporate cutting-edge regulatory science into its evaluations to support patient access to safe and effective medical products.
As a result of the 21st Century Cures Act (P.L. 114-255), FDA will continue to build on ongoing efforts to advance medical product innovation and ensure that patients get access to treatments as quickly as possible, with continued assurance from high quality evidence that they are safe and effective. Examples of the new activities carried out include:
- Further incorporating the patient perspective in the drug review process;
- Supporting the Oncology Center of Excellence;
- Advancing the review of breakthrough devices;
- Incorporating the latest in regulatory science evidence; and
- Continuing work on regenerative advanced therapies.
The FY 2018 Budget supports FDA’s critical role to ensure safe and effective medical products are advanced to market by recalibrating how to finance these activities. In a constrained budget environment, the Budget acknowledges medical product industries have sufficiently matured to assume a greater share of costs associated with FDA's administrative actions. User fees have been instrumental in allowing FDA to build capacity and improve the timeliness of the medical product review process without compromising the agency’s high standards. As part of this recalibration, accompanying the Budget will be four legislative proposals to reauthorize the prescription and generic drugs, biosimilar, and medical device user fee programs as well as additional proposals to revise the animal drugs and animal generics programs. The
Budget increases user fee resources by over $1 billion to support all medical product review and approval activities across these programs. To support speeding patient access to safe and effective medical products, the Budget also includes a portfolio of administrative actions to achieve regulatory efficiencies through programs and process improvements. These actions include:
- Encouraging the use of 21st Century Cures Act tools for drug evaluation, review, and approval;
- Simplifying administrative requirements to reduce drug and device manufacturers' reporting burden;
- Clarifying treatment of value-based purchasing arrangements; and
- Improving predictability for payers and enhanced dissemination of evidence by fostering the exchange of scientifically sound information between manufacturers and payers pre-approval to reduce uncertainty and improve payer ability to more accurately set premiums.
The Budget will advance FDA’s highest priority activities to ensure medical products available to the American public meet current requirements and standards for safety and efficacy. Medical product safety investments in the FY 2018 Budget total $3.2 billion at the program level, which is $505 million above the spending appropriated under the annualized level of the FY 2017 Continuing Resolution. This total includes $648 million in budget authority, and
$2.5 billion in user fees. In FY 2018, FDA activities include—but are not limited to—review of new medical products, research to inform sound regulatory decisions about benefits and risks of products that increasingly involve new technologies, and monitoring of the quality of marketed medical products through surveillance, inspections, and compliance programs.
The President is committed to fostering an environment that enables industry to advance innovative, safe, and effective treatments and cures to the patients who need them as quickly as possible. To achieve this goal in FY 2018, FDA will implement programs and process improvements to achieve greater regulatory efficiency and speed the availability of innovative, safe, and effective medical products in the market.
Outcomes of these efforts will include increasing engagement with manufacturers, including providing standardized and predictable pathways for early interactions to help reduce uncertainty in medical product development; reducing review times by streamlining processes and gaining efficiencies to the greatest extent possible; and reducing regulatory burden and leveraging FDA’s statutory mandates, including recent enhancements through the 21st Century Cures Act.
FDA has issued all seven foundational final rules that established the framework for a strengthened and modernized food safety system, including preventive controls for manufactured food and feed where compliance dates for larger business began in fall 2016. In FY 2017, FDA will build on these regulations and guide the modernization of our food safety system by prioritizing prevention, supporting risk-based oversight, and expanding collaboration in the food safety community. These activities ultimately will improve public health by lowering the incidence of illness due to food hazards and will avoid interruptions to the food supply.
In FY 2018, the FDA food safety portfolio will continue to support other vital food and feed safety activities that are important to the public such as improving the availability of nutritional information to assist with decisions made by individuals and their families, ensuring that food additives and color additives standards set by FDA and guarding public health by ensuring information on food labels is based on the most current science.
The Budget includes $1.3 billion for food safety across FDA programs, a decrease of $83 million below the funding appropriated by the FY 2017 Continuing Resolution. This total includes $1.2 billion in budget authority—a reduction of $109 million—and $42 million in user fees, an increase of $26 million.
In FY 2018, FDA will continue its most critical public health and safety activities, including outbreak response, implementation of Food Safety Modernization Act regulations, and ensuring that foods are safe and properly labeled. FDA will make targeted reductions to the Food Safety program, including reducing staff levels through attrition. FDA will continue support for food safety research, cosmetics safety, partnerships with academic institutes, and international capacity building at reduced levels.
Currently authorized fees support programs such as the voluntary qualified importer program, export certification, and the third party auditor program.
FDA Infrastructure and Facilities
FDA infrastructure and facilities, including 56 laboratories strategically located across the continental United States and Puerto Rico, directly support mission critical work and enable FDA to respond to food safety and medical product emergencies. These responsibilities have increased as a result of groundbreaking legislation passed over recent years, which also has resulted in additional staff. The FY 2018 Budget ensures that FDA laboratories and offices can continue to support staff in carrying out the Agency’s growing responsibilities for food and medical product safety. The Budget invests a total of $440 million - $36 million above the FY 2017 Continuing Resolution - in FDA infrastructure, including costs to keep up with the science and continue planned activities at both headquarters (including the White Oak Campus) and in the field.
The Budget also provides $9 million, the same as the FY 2017 Continuing Resolution, to fund repairs and improvements of FDA-owned facilities.
Advancing Medical Countermeasures
FDA actively supports the establishment and sustainment of an adequate supply of medical countermeasures to protect against chemical, biological, radiological, nuclear, and emerging infectious disease threats such as pandemic influenza, Ebola virus, and Zika virus. Since FY 2016, FDA mobilized more than 500 staff members to support the agency’s critical contributions to the U.S. Government’s response to the Zika virus outbreak in the Americas, and sustained response effort to the 2014 Ebola epidemic in West Africa, and the Middle East Respiratory Syndrome coronavirus outbreak, which was first noted in 2012. FDA has enabled the use of 30 diagnostic tests under its Emergency Use Authorizations authority and facilitated the development of therapeutics and vaccines to respond to those threats. FDA also issued an Emergency Use Authorizations to permit the emergency use of an atropine auto-injector to help strengthen the Nation’s public health protections against chemical threats. FDA approved the majority of medical countermeasure marketing applications under review in FY 2016 that met standards for safety, efficacy, and quality. The FY 2018 Budget includes $25 million to continue the Medical Countermeasures program which directly supports medical countermeasures efforts across FDA in support of the Department’s preparedness and response activities. These resources will help accelerate the development, evaluation, and approval of critical medical countermeasures. In addition, this funding will support the development and coordination of policies to advance emergency preparedness and response.
Reducing the Use and Harms of Tobacco
FDA, through the Center for Tobacco Products, executes its regulatory and public health responsibilities in program areas that support the following objectives: preventing initiation; decreasing the harms of tobacco product use; and encouraging cessation. Tobacco use is the leading cause of preventable disease, disability, and death in the United States. The United States spends nearly $170 billion on medical care to treat smoking-related disease in adults each year.
FDA also has contracts to conduct compliance check inspections at tobacco retail establishments with 55 States, Territories, and tribal jurisdictions. FDA publishes guidance to the tobacco industry to increase awareness of their new obligations and of FDA’s responsibilities.
The FY 2018 Budget includes $672 million in user fees to support the FDA tobacco program.
The Budget assumes resources from reauthorizing the human and generic drug, medical device, and biosimilar user fee programs set to expire at the end of FY 2017, increasing total fees collected under the animal drugs program, increasing the allowable fee amount for the export certification fee, and additional increases in all currently authorized user fee programs. Resources from user fees are critical to enable FDA to carry out its mission and institute performance metrics that lead to greater efficiencies and increased speed at which products are available to the public.