Program Alignment and ORA
- What is FDA's Program Alignment?
- Why is ORA aligning by program?
- What does FDA's Program Alignment mean for ORA?
- How does ORA's new organizational model affect FDA and FDA stakeholders?
- What does Program Alignment mean for the Food Safety Modernization Act (FSMA)? What will be different for food companies?
What is FDA's Program Alignment?
Program Alignment is a plan to modernize and strengthen the Food and Drug Administration’s (FDA) workforce to improve public health response in a way that keeps pace with the acceleration of scientific innovation, global expansion of markets, and new programmatic mandates.
This is a major next step in FDA’s continuing process to enhance its ability to protect the public health and will allow employees to become more specialized in their work where appropriate and modify certain processes with the goal of improved cross-agency communication, collaboration, and clarity in roles and responsibilities.
Why is ORA aligning by program?
Over the years, the products the FDA regulates have become more complicated, the markets are more numerous and the rules governing the agency’s actions are more complex. The FDA’s operational models need to continue to adapt to meet those challenges and improve its efforts to protect public health. Program Alignment enables ORA’s workforce to help shape the policies that govern its activities and fully align and integrate with other staff throughout the agency who are doing complementary work within a given product area. Creating distinct product-based and vertically integrated regulatory programs enables the agency to best achieve its objectives, to optimize the coordination and efficiency of the work performed between all FDA centers, directorates and ORA, to strengthen accountability and to reduce duplication. The new structure will also enable staff to work more closely with FDA scientific and technical experts on complex, scientific, manufacturing and other regulatory challenges.
What does Program Alignment mean for ORA?
On May 15, 2017, as part of the broader agency Program Alignment initiative, the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) will implement a program-based management structure that aligns staff by FDA-regulated product. This organizational approach replaces a management structure based on geographic regions.
Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA’s centers and the industries we regulate. This will enhance the effectiveness of our communications, our processes, and our ability to keep pace with scientific innovation and protect public health.
Visit ORA's Program Division Boundary Maps and Fact Sheets page for additional information.
How does ORA's new organizational model affect FDA and FDA stakeholders?
In the new organizational model, for a given product type, the entire reporting chain for ORA’s inspection and compliance staff--from the employees on the front lines to the assistant commissioners at headquarters--will specialize in that particular commodity. This is a significant change from ORA’s existing geographic-based model, where employees, regardless of their area of expertise, may do work in more than one program area. Ultimately these changes will result in a high level of technical expertise and more uniform application of ORA’s policies and processes.
The goal is to improve our public health response in a way that keeps pace with the acceleration of scientific innovation, global expansion of markets, and modern legal authorities.
Legal authorities such as:
- the Family Smoking Prevention and Tobacco Control Act of 2009,
- the FDA Food Safety Modernization Act of 2011,
- the FDA Safety and Innovation Act of 2012,
- the Generic Drug User Fee Act, and
- the Drug Quality and Security Act of 2013
- the 21st Century Cures Act of 2016
The FDA Program Alignment initiative and ORA’s new organizational structure moves the agency toward a more collaborative program-based model.
What does Program Alignment mean for the Food Safety Modernization Act (FSMA)? What will be different for food companies?
As a result of restructuring and specializing under Program Alignment, the FDA will be better positioned to implement our authorities under the Food Safety Modernization Act (FSMA). The new organizational model will result in more uniformity in both process and policy across the organization, and more seamless and coordinated interactions within the FDA, between the field and the centers, with other federal agencies, and with our state regulatory and public health departments. FSMA involves the creation of a new food safety system with emphasis on prevention and accountability. The FDA’s program-aligned staff will be more efficient and able to focus on specific commodities. And, since the specialized staff in the Human and Animal Food program will be trained similarly, industries across the globe will experience more uniform and consistent application of FDA’s inspectional approach.
Program Alignment Resources
- FDA Program Alignment and Action Plans
- Program Alignment Group Recommendations - Decision
- Office of Regulatory Affairs Organization Chart
- ORA Program Division Boundary Maps and Fact Sheets
- Integration of the Facility Evaluation and Inspection Program for Human Drugs - A New Operating Model