2015 FDA Budget Request Supports 5-Year Strategic Plan

In April 2011, FDA published a five-year strategic plan, entitled “Strategic Priorities 2011 – 2015.” In that plan, FDA set forth five modernization priorities for the agency. The plan also committed to using these priorities to improve agency infrastructure, modernize the regulatory processes, strengthen its workforce, and, ultimately, do a better job promoting and protecting the health of Americans. The five modernization priorities are:

  • Advance Regulatory Science and Innovation
  • Strengthen the Safety and Integrity of the Global Supply Chain
  • Strengthen Compliance and Enforcement Activities to Support Public Health
  • Expand Efforts to Meet the Needs of Special Populations
  • Advance Medical Countermeasures and Emergency Preparedness.

Since 2011, the FDA budget requests have focused on these five strategic priorities. The President’s Fiscal Year (FY) 2015 Budget Request also tries to build FDA capacity in these five areas.

 Budget Overview

The FY 2015 FDA Budget Request (Justification of Estimates for Appropriations Committees) totals $4.74 billion, which is $358 million above the FY 2014 enacted level and is comprised of $2.58 billion in budget authority and $2.16 billion in user fees. The $358 million increase consists of $23 million in budget authority and $335 million in user fees. The user fee funding growth flows from new programs and increased user fee collection authority for FDA’s existing programs.

 Budget Increases

The increased spending in the FY 2015 Budget Request focuses on (1) medical product safety, (2) strengthening oversight of the pharmacy compounding industry, (3) supporting food safety, and (4) implementation of the Food Safety and Modernization Act (FSMA) (P.L. 111-353).  Here is the breakdown:

  • Medical product safety. The budget provides a program level of $2.6 billion for medical product safety, which is $61 million above the FY 2014 enacted level, to continue core medical product safety activities across FDA programs.
  • Pharmacy compounding. Out of the $61 million in medical product safety spending, FDA will invest $25 million in budget authority to enhance pharmacy compounding oversight activities. This request also includes $4.6 million for proposed International Courier user fees.
  • Food safety. The budget provides a program level of $1.48 billion for food safety, which is $263 million above the FY 2014 enacted level. This request also includes $255 million in proposed new user fees.
  • FSMA implementation. Within the $1.48 billion proposed for food safety, FDA will invest $24 million to further implement the FSMA.

The spending for further FSMA implementation includes: (1) finalizing mandated rulemakings on preventive controls for human and animal food, produce safety, and foreign supplier verification; (2) developing technical support for ongoing FSMA guidance development; (3) increased training and certification of federal, state, local, tribal, territorial, and international partners conducting food safety inspections; (4) supporting state capacity building, FDA-state joint work planning and data sharing, and collaborative agreements, such as the Manufactured Food Regulatory Program Standards; (5) increased data gathering and analytical capacity to support risk-based priority setting and resource allocation; and (6) phasing out animal production uses of medically important antimicrobial drugs and bringing the remaining legitimate animal health uses under veterinary supervision.

 New User Fees

 The FY 2015 Budget Request proposes new user fees for food imports, food facility registration and inspection, food contact substance notification, cosmetics, and international couriers.

  • Food safety.  To support implementation of FSMA, FDA is proposing $169 million in new user fees for Food Import and $60 million for Food Facility Registration and Inspection. These fees will be used to improve FDA’s import process and modernize FDA’s food facility inspection system.
  • Food contact substance notification. FDA is proposing a new user fee of $5.1 million to ensure that the Food Contact Substance Notification (FCN) program operates more predictably by providing a stable, long-term source of funding to supplement budget authority appropriations. Section 409(h)(5) of the Food Drug & Cosmetic Act (FDC Act) (21 U.S.C. sec. 348(h)(5)) specifies that the FCN program can operate only if adequately funded. The proposed user fee will provide greater predictability of program funding and operations.
  • Cosmetics. FDA is proposing a new user fee of $19.5 million to support FDA cosmetic safety responsibilities. The FDC Act does not currently authorize FDA to collect user fees to support its Cosmetics Program. The proposed user fees will improve FDA’s capacity to promote greater safety and understanding of cosmetic products.
  • International courier. FDA is proposing a new International Courier user fee to support activities associated with increased surveillance of FDA-regulated commodities at express courier hubs. Approximately 20 percent, or $1.2 million of this $4.6 million proposed fee will support imported food safety. The user fee will help FDA keep pace with growing volume of imports that enter through international couriers and the increased cost of import operations.

 Current User Fees

Included in the funding request for medical product and food safety, FDA is requesting a $75.4 million increase for current user fees. The current user fees support the review and surveillance of human and animal drugs, medical and mammography devices, food and feed, color additives, export certification, and tobacco products.

 Medical Countermeasures

The FY 2015 Budget Request asks for $24.5 million to continue medical countermeasures (MCMs) across FDA programs. MCMs, such as drugs, vaccines, and diagnostic tests, are used to protect the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. The FDA plays a critical role in ensuring that these MCMs are safe, effective, and secure. This 2015 request is $48,000 below the FY 2014 enacted level due to decreased rent costs.

 Infrastructure, Rent, and White Oak Consolidation

Included in the funding request for medical product and food safety, and medical countermeasures, FDA is requesting an increase of $5.8 million for infrastructure. The FDA is also requesting a $20.6 million increase for Government Services Administration rental payments and other rent and rent-related costs, such as guard services and security systems. Finally, the proposed budget calls for $47.1 million ($14.8 million below the FY 2014 enacted level) for the ongoing and expanded operational and logistical functions for 9,000 employees on the White Oak Campus.