Fiscal Year 2010

Office of International Programs
U.S. Food and Drug Administration
Action Plan for Capacity Building FY 2010

Background

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.

As a regulatory agency in the 21st century, FDA has an international component that underpins its domestic mission. FDA’s international scope has expanded in recent years in line with FDA’s regulatory challenges due to globalization. The FDA's Office of International Programs (OIP) advances the mission of the FDA and public health worldwide in partnership with other FDA components, other U.S. agencies, foreign governments and international organizations.

OIP leads, manages and coordinates the agency’s international engagement. The FD & C Act mandates, as a core mission of FDA, collaboration with foreign regulatory counterparts to reduce regulatory burdens, harmonize regulatory requirements, and establish appropriate reciprocal arrangements. A significant recent increase in the global discovery, development and production of essentially all FDA-regulated products and much of the clinical data supporting their authorization, requires that FDA further develop and enrich its cooperation and collaboration with its counterpart foreign regulatory authorities and multilateral international organizations in order to help meet FDA’s domestic mission of protecting and promoting public health. In short, in order to be more effective at home, FDA must engage more effectively on a global scale. OIP and other FDA components accomplish this through a variety of bilateral, regional, and multilateral relationships that are undergirded by formal agreements and now through the efforts of its new foreign posts.

Depending on resources and competing priorities, FDA Centers and Offices have historically offered to some extent, technical assistance or capacity building to various regulatory counterparts globally. While most requests for assistance have traditionally been in the areas of foods and drugs, other types of requests for assistance as well as FDA’s own need to expand its role globally is increasing, e.g., vaccine development, medical device unique identifiers standards, and global food safety surveillance and reporting systems. These requests include the provision of scientific, technical, regulatory, or inspection assistance, and education and training to counterpart regulatory agencies, to help strengthen public health regulatory infrastructures abroad, especially for countries where exports to the United States are significant or increasing.

OIP Capacity Building

With Fiscal Year 2008 supplemental funding and FY 2009 appropriations, OIP’s capacity- building resources have increased significantly. This corresponds to the Agency’s increasing responsibilities, both domestic and international responsibilities that support the safety and quality of FDA-regulated products prior to reaching U.S. ports of entry. FDA recognizes that quality and safety must be integrated throughout the life-cycle of products, with preventive controls, science-based regulatory practices and comprehensive regulatory guidelines supporting the manufacturing or production processes.

OIP capacity-building and technical cooperation incorporates the following concepts:

• Reflects a intra-Agency commitment toward international capacity building to ensure an efficient use of FDA financial and expert resources and an integrated approach to FDA’s international efforts overall; 
• Within a multilateral context, positions the FDA in ways that effectively exert its technical leadership and scientific capabilities; help to guide global initiatives using public health and science as critical drivers; and/or work to better align, reinforce, or increase willingness of other countries, to implement internationally harmonized standards, practices and methodologies, especially where such harmonization aligns well with FDA domestic practices. 
• Strengthens in measurable ways, foreign regulatory authorities’ appreciation and ability to regulate and enforce rigorous science-based safety standards for products, domestically and those exports targeting U.S. ports of entry; 
• Works through sustainable partnership approaches, including collaborations (public/ private and public/public) that strengthen the regulatory infrastructure of counterpart agencies abroad; 
• Helps to strengthen and reinforce FDA International Offices’ roles as an in-country portal to the larger FDA; and 
• Leverages resources, promote technology exchange and helps to strengthen or reinforce science-based regulatory systems.

Beginning in FY 2010, the Office of International Programs, working through the International Working Group’s SubGroup on Capacity Building (IWG/SCB), will coordinate FDA’s portfolio and strategy for capacity-building applying the following guiding principles:

Guiding Principles for Capacity Building Activities

Any activity to be considered:

• aligns well with Presidential, Departmental, or Agency programs, with an emphasis on FDA’s programs and priorities, e.g., the Import Safety Action Plan, Food Protection Plan, regulatory problem-solving, or other activities that require FDA to work with a foreign regulatory counterpart. 
• positions FDA in technical leadership roles to help steer global initiatives, decisions or actions in ways that align well with FDA priorities and sound public health practices. 
• reflects FDA’s priority product and import safety concerns as evidenced by FDA databases, inspection reports, and other information. 
• is a contributory element of a larger FDA strategy and is NOT a stand-alone activity. 
• to ensure sustainability, is developed in collaboration with the appropriate foreign regulatory authority, foreign private sector entity, multilateral organization or other U.S. Government agency. 
• does NOT replace Centers’ international efforts. OIP recognizes that FDA Centers are longstanding players globally and OIP CB funds should be work to leverage existing efforts, provide additive contributions, or support new priority areas. 
• require reporting feedback to OIP, including delineation of measurable outputs and analyses of the effort/activities, as well as identifying the resulting impacts(s) using a forward-looking lens. 
• utilizes existing regional training efforts and capitalizes on regional/multiple country programs whenever possible, including established capacity building programs of other regulatory authorities. 
• is cleared by the Deputy Commissioner for International Programs and included in the overall Agency Master Plan for capacity building and technical assistance activities. This includes capacity building activities funded by OIP and those funded by Centers, ORA, or OC Offices. This is to help assure that all activities are coordinated across the agency to best leverage agency resources and are coordinated with those in-country who will be responsible for overseeing the in-country elements and activities with in-country counterparts/industry of such initiatives.

As OIP looks ahead at capacity building beginning in FY 2010, the CBS/IWG subgroup will work in an integrated approach to identify and recommend areas and efforts that are of priority to the Agency applying the above concepts and guiding principles, while recognizing other FDA capacity-building efforts supported through non-OIP resources, e.g., ORA-U web-based training, annual Center international fora.

OIP will also work closely with the Office of Acquisitions and Grants Services to identify and implement processes and instruments that effectively commit OIP (and possibly other) capacity building funds, e.g., competitive cooperative agreement, using OIP funds as the core but enable other FDA Centers and Offices to “tack on” their funds for specific activities.