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||2015 /1||2016||2017||2017 +/− 2016|
|Animal Drugs and Feeds||175||189||197||+8|
|National Center for Toxicological Research||63||63||60||-3|
|Headquarters and Office of the Commissioner /2||277||290||299||+9|
|White Oak Consolidation||47||52||47||-5|
|GSA Rental Payment||228||239||240||+1|
|Other Rent and Rent-Related Activities||116||120||124||+4|
|Subtotal, Salaries and Expenses||4,476||4,716||4,990||+275|
|Export Certification Fund||5||5||9||+4|
|Color Certification Fund||8||9||10||+2|
|Priority Review Vouchers||8||8||8||--|
|Buildings and Facilities||9||9||12||+3|
|Cancer Initiative (Directed Mandatory Transfer from NIH)||--||--||75||+75|
|Total, Program Level||4,505||4,745||5,104||+358|
|Current Law User Fees /3||2015 /1||2016||2017||2017 +/− 2016|
|Prescription Drug (PDUFA)||798||851||866||+14|
|Medical Device (MDUFA)||128||138||145||+7|
|Animal Drug (ADUFA)||22||23||23||+0|
|Animal Generic Drug (AGDUFA)||7||10||10||+1|
|Family Smoking Prevention and Tobacco Control Act||566||599||635||+36|
|Generic Drug (GDUFA)||312||318||324||+6|
|Mammography Quality Standards Act (MQSA)||20||20||21||+0|
|Export Certification Fund||5||5||5||--|
|Color Certification Fund||8||9||10||+2|
|Third Party Auditor Fee||--||1||1||--|
|Voluntary Qualified Importer Program||5||5||5||--|
|Outsourcing Facility Fee||1||1||1||+0|
|Priority Review Vouchers||8||8||8||--|
|Subtotal, Current Law User Fees||1,909||2,017||2,084||+66|
|Proposed Law User Fees||2015 /1||2016||2017||2017 +/− 2016|
|Export Certification /4||--||--||4||+4|
|Food Facility Registration and Inspection||--||--||61||+61|
|Food Contact Substance Notification||--||--||5||+5|
|Subtotal, Proposed Law User Fees||--||--||202||+202|
|Less Total, User Fee||1,909||2,017||2,286||+269|
|FDA Totals||2015 /1||2016||2017||2017 +/− 2016|
|Total, Discretionary Budget Authority||2,596||2,728||2,743||+15|
1/ In addition, the FY 2015 appropriation (P.L. 113-235) provided $25 million in emergency resources for Ebola response and preparedness activities.
2/ The FY 2015 and FY 2016 appropriations directed FDA to transfer a total of $1.5 million to the HHS Office of Inspector General for oversight activities.
3/ 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. FDA expects that collections for wholesale distributer and third-party logics provider fees in FY 2015, FY 2016, and FY 2017 will be minimal.
4/ The FY 2017 President’s Budget proposes to increase the statutory user fee limit for export certification.
The FY 2017 Budget includes $5.1 billion in total resources for the Food and Drug Administration (FDA), an increase of $358 million, or 8 percent above FY 2016. Of this increase, $15 million is in budget authority, $269 million in user fees, and $75 million in new mandatory funding. FDA’s jurisdiction of products and activities is vast, ranging from over-the‑counter drugs to infant formula, and the challenges to secure the safety of these products increases in complexity with a growing global market.
FDA estimates that Americans pay about two cents per day to ensure that the products FDA regulates, representing more than 20 percent of every consumer dollar spent on products in the United States are safe and effective.
The Budget will continue to invest in transforming the food safety system to address today’s challenges, ensuring the safety and efficacy of medical products, supporting the Department’s preparedness enterprise, reducing tobacco use, and conducting innovative research.
Modernizing the Food Safety System
FDA oversees the safety of approximately 80 percent of the food supply, including a growing proportion of imported products. The Food Safety Modernization Act (FSMA) was enacted in 2011 and provided FDA with the authorities to transform the food safety system by shifting the focus from responding to foodborne illness and other food hazards to preventing them.
Over the last five years, FDA has provided training and technical assistance to industry partners to facilitate understanding and compliance with the new standards; developed tools that will provide the information needed to focus decisions and resources on areas of greatest risk; increased capacity to support an integrated food safety system, and conducted 7,020 high-risk food establishment inspections.
In 2015, FDA issued five foundational final rules that established the framework for a secure food supply, including preventive controls for food and feed, and will continue in 2016 with finalizing two more. 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 the public health by lowering the incidence of illness due to food hazards and will avoid interruptions to the food supply.
Empowering Americans to Make Informed Nutritional Decisions
The Nutrition Facts label, which is a label required on most packaged foods, has not changed significantly since the requirements were first introduced in 1993. FDA has proposed to update the Nutrition Facts label to reflect new public health and scientific information, including evidence on nutrition, obesity and chronic disease. This includes updating the look and content of the Nutrition Facts Label to better help consumers make informed food choices and follow healthy dietary practices. One change includes updating the label to better reflect a single serving, which has changed in the decades since the original nutrition label was created. Informed food choices is another step towards addressing the current obesity rate estimated to be over one third of the country.
The Budget includes $1.5 billion for food safety across FDA programs, an increase of $212 million above FY 2016, an increase of $18 million in budget authority and $193 million in user fees. This total includes $1.3 billion in budget authority and $210 million in user fees. In FY 2017, FDA will focus on implementing produce standards for packing, harvesting, and growing fruits and vegetables; and ensuring imported foods meet the same standards of safety as those in the United States.
In FY 2017 FDA will focus on the following objectives in support of FSMA:
- Increasing state capacity to implement FSMA produce safety rules;
- Implementing the Foreign Supplier Verification Program to ensure importers verify that imported foods have been produced in a manner consistent with FSMA’s new standards for produce safety and preventive controls; and
- Expanding foreign inspections and the agency’s overseas presence.
The Budget proposes new user fees including the food import fee and the food facility registration and inspection fee. The additional $193 million in new resources are vital to fully support robust implementation of a prevention based food safety system. The FDA Budget continues to propose the food contact substance notification user fee to reduce microbial food contamination through premarket notification, as well as including currently authorized fees that will support food safety across 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. These programs include: the voluntary qualified importer program, export certification, third party auditor program, and the food reinspection and recall fees.
In FY 2017, 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 coloring meet standards set by FDA, and guarding public health by ensuring information on food labels is based on the most current science. For example, the Center for Food Safety and Applied Nutrition is proposing to update the Nutrition Facts Label to better reflect new scientific information and changed consumer preferences.
Enhancing Medical Product Safety
FDA continues to make significant progress in reducing the number of drug shortages, from a high of 251 shortages in 2011 to just 44 new shortages in 2014. Today, FDA leads the world in both the number of new drugs approved and in the timeliness of their reviews. These are just a few examples of the critical role FDA plays on a daily basis to ensure Americans have access to safe and effective products. As the global market grows and complex challenges arise, FDA is working to keep pace with the latest science and leverage state, local, and foreign partnerships to protect the public health. Initiatives across FDA programs continue to address new and emerging technologies in regulatory science including 3-D printing, genome sequencing, and computer simulations.
FDA ensures the safety, quality and effectiveness of a broad scope of medical products used by Americans including biologics such as vaccines, blood products, and gene therapies, prescription and over-the-counter drugs, radiation emitting products, and medical devices ranging from dental devices to surgical implants. In March 2015, FDA approved Zarxio, the first biosimilar biological product approval in the United States. Zarxio, which is biosimilar to the biological product Neupogen, is a medication that boosts the production of white blood cells and helps to ward off infection in patients receiving strong chemotherapy for some tumors. This significant accomplishment represents the next step to increasing treatment options for patients.
In 2016, FDA will support implementation of three activities of the Food and Drug Administration Safety and Innovation Act (FDASIA):
- Unique Facility Identifier;
- Unique Device Identifier; and
- Electronic Biological Product Application Submission programs.
These activities will continue in FY 2017 to improve patient safety by establishing systems that will allow standardized approaches to quickly and efficiently identify drug and device products in the market and streamline the way biologics are reviewed.
FDA is also working on long-term implementation of the track and trace system authorized in the Drug Quality and Security Act for enhanced drug distribution security. The system will further enable the identification and verification of the legitimacy of certain prescription drugs, and become an important tool in the fight against counterfeit, diverted, or stolen drugs. In addition, in 2015, FDA successfully launched a mobile application to improve public access to information, including current drug shortages, and resolve drug shortages and discontinuations of drug products. In FY 2017, FDA will continue to invest in developing a safer and more modern drug supply system by building on the infrastructure to process biological product applications and support integration of the Unique Facility Identifier into IT systems that support regulatory work.
In addition, FDA is making strides to improve the efficiency of the generic drug review process. FDA supports the program’s goal to enhance access to high‑quality, lower cost generic drugs. This commitment is reflected in the performance target, which increases from 75 percent of Abbreviated New Drug Application submissions reviewed in 15 months in FY 2016 to 90 percent reviewed in 10 months in FY 2017.
Medical product safety investments in the FY 2017 Budget total $2.8 billion at the program level, $116 million above FY 2016. This total includes $1.3 billion in budget authority, $1.4 billion in current law user fees, and $75 million in new mandatory funding. The Budget will advance FDA’s highest priority activities to ensure that human and animal drugs, biologics, and medical devices available to the American public meet current requirements and standards for safety. In FY 2017, FDA activities include but are not limited to domestic and foreign drug establishment inspections, pre-and post-market product surveillance, research on biologics, human drugs, and devices to help inform FDA program’s and the medical product community, and review of new medical products that will be available to the public.
The Budget includes a total of approximately $18 million in budget authority, an increase of $1 million above FY 2016, to continue and extend FDA’s oversight of drugs produced by compounding pharmacies and outsourcing facilities. Increased efforts in these areas will help to prevent outbreaks that could result in deaths or injuries to patients who receive compounded drugs. Oversight of compounding facilities is critical to protecting patients. In FY 2015, FDA conducted 116 inspections of compounding pharmacies and outsourcing facilities across the nation. Funding requested in the Budget will build on FY 2016 activities, including inspection and enforcement, developing policies that will ensure compliance with the Drug Quality and Security Act, and facilitating state collaboration and coordination.
The Budget includes $42 million in support of the Administration’s National Strategy for Combating Antibiotic Resistant Bacteria, the same as FY 2016, which will advance efforts to support the judicious use of medically‑important antimicrobials in food‑producing animals, to evaluate new antibacterial drugs for patient treatments, to streamline clinical trials, and to develop better vaccines for antibiotic resistant organisms. Fighting antibiotic resistance is both a public health and national security priority, and FDA has made strides to make sure effective antibiotics are available in the future. The Budget will build on FDA’s current work in this area, which includes implementing the Veterinary Feed Directive, which would make illegal the use of medically important antibiotics for animal production purposes and bring remaining uses for legitimate animal health purposes under veterinary supervision.
Developing a Collaborative Platform to Advance Precision Medicine
In January 2015, the Precision Medicine Initiative was launched to empower health care providers to tailor treatment and prevention strategies to individuals’ unique characteristics and genetic makeup. Achieving this vision will require ensuring the accuracy of genetic tests in detecting and interpreting genetic variants in the human genome. More than 80 million variants have been found in the human genome.
To that end, FDA developed precisionFDA, an online, cloud-based, portal that will allow scientists from industry, academia, government and other partners to come together to foster innovation and develop the science behind a method of reading DNA known as next‑generation sequencing.
precisionFDA will supply an environment where the community can test, pilot, and validate new approaches. For example, next-generation sequencing test developers, researchers, and other members of the community can share and cross‑validate their tests or results against crowd-sourced reference material in precisionFDA.
FDA is also a key participant in the President’s Precision Medicine Initiative. In the last year, FDA has approved several new Precision Medicine-based therapies and launched precisionFDA, a platform for academic and commercial collaboration. The Budget includes $4 million, an increase of $2 million above FY 2016, to support these activities including supporting precisionFDA and working with the scientific community to develop new reference datasets for validating genetic tests. FDA’s advancement of precision medicine will help reduce the burden of disease by targeting prevention and treatment more effectively. These efforts directly support precision medicine activities across HHS.
The Budget also provides $75 million in mandatory resources over five years in order to accelerate progress in cancer as part of the Vice President’s Cancer “Moonshot” initiative. FDA will closely interface with the NIH National Cancer Institute to streamline the development and expedite the approval of novel devices, drugs, biologics, and combination products. FDA will also support improved access to new treatments through cancer clinical trials and access programs, and will enhance sharing of cancer data from clinical trials to promote biological and clinical breakthroughs.
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 safety activities. These responsibilities have increased as a result of groundbreaking legislation Congress has passed over recent years, and as a result, FDA has experienced a significant increase in its workforce to carry out these activities. The FY 2017 Budget ensures that FDA facilities are optimally functioning to carry out its growing responsibilities for food and medical product safety. The Budget invests a total of $423 million, $4 million above FY 2016, in FDA infrastructure including costs to keep up with the science and continue planned activities in the White Oak Complex. In 2016, FDA will complete a feasibility study at the White Oak Campus to address its expanded workforce as well as the continued consolidation and construction required to accommodate them. These resources will also ensure FDA’s leased offices and labs across the country are functional and support the workforce in meeting its public health mission.
In addition, the Budget provides $12 million, an increase of $3 million above FY 2016, to fund repair and maintenance of FDA-owned facilities. This investment will begin to address high priority needs across owned facilities to ensure FDA can achieve its regulatory responsibilities, strategic priorities, and program initiatives. These investments directly support FDA’s ability to carry out its responsibilities in facilities that can meet modern challenges.
Advancing Medical Countermeasures
FDA supports the establishment and sustainment of an adequate supply of medical countermeasures to protect against chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA approved the majority of medical countermeasure marketing applications under review in FY 2015 that met standards for safety, efficacy, and quality. The FY 2017 Budget includes $25 million to continue the Medical Countermeasures Initiative program which directly supports FDA’s countermeasures efforts across the agency and the Department’s preparedness activities. These resources will help accelerate the development, evaluation, and approval of these countermeasures. In addition, funding will support establishing clear regulatory and policy frameworks to supports emergency preparedness and response.
Reducing the Use and Harms of Tobacco
Tobacco remains the leading preventable cause of disease, disability, and death in the United States. The adverse health effects from tobacco cause more than 480,000 deaths each year. In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, which gave FDA authorities to regulate the manufacturing, distribution, and marketing of tobacco products. This legislation has enabled FDA to make significant progress towards making tobacco-related death and disease a part of the nation’s past and not its future. FDA has moved science‑based tobacco regulation forward and started a rigorous tobacco research program. FDA, through the Center for Tobacco Products, executes its regulatory and public health responsibilities in program areas that support the following objectives: preventing initiation, particularly among youth; decreasing the harms of tobacco product use; and encouraging cessation.
The Center for Tobacco Products continues to build on accomplishments to prevent tobacco use in youth; educate Americans on the harms of tobacco products; ensure compliance with the Tobacco Control Act; review new tobacco products and changes to existing products to reduce harm; and, support cutting edge research. As of January 2016, FDA completed over 549,300 inspections of tobacco product retailers across the United States to ensure that industry is meeting new requirements and issued more than 38,800 warning letters to retailers for violating the law. In October 2015, FDA filed complaints initiating the first‑ever No-Tobacco Sale Order actions for a group of retailers who had violated certain restrictions on the sale and distribution of tobacco products, including sales to minors. If an order goes into effect, a retailer is responsible for ensuring that the establishment does not sell regulated tobacco products during the specified period.
Reducing Tobacco Use among At-Risk, Multi‑Racial Youth
In May 2015, FDA launched the first phase of its “Fresh Empire” campaign, which is designed to prevent and reduce tobacco use among at-risk multi‑racial youth aged 12 to 17 who may become regular smokers.
“Fresh Empire" targets youth who identify with the hip-hop peer crowd— a hard-to-reach group that historically has been underserved by tobacco prevention campaigns. The aim of the campaign is to associate living tobacco-free with desirable hip-hop lifestyles through a variety of interactive marketing tactics including the use of traditional paid media, engagement through multiple digital platforms, and outreach at the local level.
The launch of this campaign follows the award‑winning “Real Cost” campaign from 2014, which will also receive additional advertising. As of September 2015, the campaign has reached more than 90 percent of the target audience at least 15 times a quarter, generated nearly 2.5 billion digital impressions on youth-focused websites. FDA plans to launch additional public education campaigns in 2016 including rural youth at risk of smokeless tobacco initiation and lesbian, gay, bisexual, and transgender young adults. In 2017, FDA will continue to build on these campaigns to reach out to youth.
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.
As part of its implementation of the Tobacco Control Act, FDA will extend its tobacco authority to cover additional tobacco products that are currently unregulated in the market. This extension will enable FDA oversight and the use of regulatory tools, such as age restrictions and scientific review of new tobacco products, to help limit youth exposure that could lead to a lifetime of nicotine addiction.
The FY 2017 Budget includes $596 million in user fees to support the FDA tobacco program and contributes to the Department’s crosscutting efforts to reduce tobacco use in the United States. FDA will focus resources on five strategic priorities: 1) product standards to protect public health; 2) an FDA‑wide nicotine regulatory policy; 3) premarket and post market product controls: regulations and product reviews; 4) compliance and enforcement through inspections, investigations, monitoring, and review of covered tobacco products; and 5) public education efforts particularly among youth.
The Budget assumes resources from five new user fee programs, an increase to one currently authorized fee program, and scheduled 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.
In addition to the fees described above, the Budget proposes two additional user fee programs. First, the Budget continues to propose the international courier user fee, which would provide $6 million to support activities associated with increased surveillance related to the increased volume of FDA‑regulated commodities, predominantly medical products, imported through express courier hubs. This request also includes the proposed cosmetic user fee totaling $20 million to 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.
Finally, the Budget proposes to increase the allowable fee amount for the export certification fee to keep up with the growing costs of these certification activities.