June 24, 2020
By Anna Abram and Mark Abdoo
Every day Americans consume food and use medical products that originate from outside of the United States – such as produce from Mexico, sea bass from Chile, drugs from India and medical devices from Germany.
Our mission to protect and promote public health for Americans requires a dedicated global focus given the increasingly complex global landscape of the products FDA oversees. That’s why FDA believes it is critical for the agency to have an office devoted to helping advance its mission of protecting and promoting the public health of Americans in our work abroad.
The Office of Global Policy and Strategy (OGPS), which has offices at six foreign posts as well as FDA’s White Oak headquarters, fulfills this role within the agency. It was stood up more than a year ago, as part of a broader reorganization of the Office of the Commissioner. The former Office of Global Regulatory Operations and Policy (OGROP) was divided into a free-standing Office of Regulatory Affairs and OGROP’s Office of International Programs became OGPS, with the addition of OGROP’s trade work and its Immediate Office. Thus augmented, OGPS, led by Associate Commissioner Mark Abdoo, was placed under the Office of Policy, Planning and Legislative Affairs, which became the Office of Policy, Legislation and International Affairs, led by Deputy Commissioner Anna Abram.
These structural changes enhance the breadth of the Office’s international policy, diplomacy, and compliance work and better enable the agency to respond to its global mission. OGPS has three operating sub-offices based around our key focus areas – partnerships and multilateral diplomacy (Office of Global Diplomacy and Partnerships or OGDP); operations and maintenance of our foreign posts and any associated policy work (Office of Global Operations or OGO); and development of formal inter-governmental arrangements and issues related to the importation of FDA-regulated products (Office of Trade, Mutual Recognition and International Arrangements or OTMRIA).
Shortly after the realignment, OGPS initiated a strategic planning effort to develop a five-year strategic plan and communication and implementation roadmap for the new office. This comprehensive document defines the direction of the office for the next five years, sets and establishes goals and priorities, focuses efforts and resources, strengthens operations, and supports employees’ work towards the OGPS mission.
Specifically, the strategic plan identifies four complementary and connected strategic priority areas for our office and sub-offices that will guide our work and direct how we put our mission into practice. They are: Organizational Excellence (fostering an inclusive, supportive, high performance organization that values employees); Policy Coherence (promoting policy coherence and mutual understanding across FDA Centers/Offices and across the globe); Global Partnerships (leveraging partnerships to strengthen regulatory systems; promote the development of efficient, predictable, modern, and science-based regulatory frameworks; and assure that products entering the U.S. market meet FDA requirements); and Information Collection and Dissemination (informing regulatory, compliance, and public health decisions through collection, analysis, and dissemination of information). Importantly, the strategic priorities align with FDA’s objectives and support the goals established in HHS’s Strategic Plan FY 2018 - 2022 to enhance the health and well-being of all Americans.
Work on the OGPS Strategic Plan was led by the OGPS Planning and Evaluation Team and an internal Strategic Planning Workgroup composed of representatives from each OGPS sub-office. They began by conducting a comprehensive assessment of the current office that included a SWOT analysis, a gap analysis, a review of archival documents and interviews with leadership.
What emerged from this process was a thoughtful list of potential opportunities for OGPS, which included serving as a facilitator across the agency for implementing FDA policies with global implications and conduct. This led to policy coherence becoming one of our strategic goals.
We understand that the important work ahead of us will only be achievable if we have a robust, high performing workforce. Therefore, our strategic goal on organizational excellence includes a number of planned activities to help us cultivate and maintain a successful organization that attracts and retains highly-skilled workers and embodies a culture of inclusivity, collaboration, and continuous improvement.
There are dozens of other activities that, taken together over the long-term, will only make us stronger and more responsive to the American people and our vital public health mission on their behalf. We’re excited to begin implementing them.
In the coming year, OGPS will work to develop and implement measures and evaluation approaches which demonstrate our progress towards achieving the goals of the plan and our office’s impact on FDA-regulated products.
We know from the ongoing COVID-19 pandemic that conditions can change - and change quickly. As a result, we intend the OGPS Strategic Plan to serve as a living document. While the plan outlines strategic priorities and supports goals and objectives involving OGPS’s ongoing work, OGPS will also emphasize the importance of continuous improvement, focusing the plan on new areas as they arise and adapting as necessary to achieve our public health mission. We welcome feedback as OGPS strives to fulfill its four strategic goals, all aimed at protecting and promoting the public health of the American people.
Anna Abram is FDA's Deputy Commissioner for Policy, Legislation, and International Affairs
Mark Abdoo is FDA's Associate Commissioner for Global Policy and Strategy