March 31, 2020
By Mark Abdoo
Today marks the one-year anniversary of our Office of Global Policy and Strategy (OGPS). On March 31, 2019, FDA reorganized the Commissioner’s Office to increase efficiencies, better meet the demands of our work environment, and enhance collaboration efforts across commodities and policy areas.
This reorganization included the realignment of operations within the Global Regulatory Operations and Policy (OGROP) directorate, then under Acting Deputy Commissioner Mark Abdoo, into new offices. The Office of Regulatory Affairs, then part of OGROP, became a free-standing office and OGROP’s Office of International Programs became our Office of Global Policy and Strategy, with the addition of OGROP’s trade work and its Immediate Office. Thus enhanced, OGPS, led by Associate Commissioner Abdoo, was placed under the Office of Policy, Planning and Legislative Affairs, which became the Office of Policy, Legislation and International Affairs (OPLIA).
In turn, OGPS itself was structured into three sub-offices, based around our key focus areas: partnerships and multilateral diplomacy (Office of Global Diplomacy and Partnerships (OGDP)), operations and maintenance of our foreign posts and any associated policy work (Office of Global Operations (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 (OTMRIA)). This new structure was intended to enhance the breadth of OGPS’s international policy, diplomacy, and compliance work in the U.S. and at our foreign posts.
The early stages of the reorganization required the usual operational changes including a redo of our external website and the issuance of new SF50s, i.e., Notifications of Personnel Action for each employee, a required function following a reorganization. But our office barely lost a step during this period. And looking back, I’m proud to say that our fledgling organization has managed to accomplish an extraordinary amount in its first year.
Some highlights include:
- Completing capability assessments for all 28 EU Member States for the Pharmaceutical Annex to the Mutual Recognition Agreement with the EU, which will help the FDA better direct our resources to the oversight of drug manufacturing facilities that represent a greater risk to public health;
- Providing local support in China to review and confirm local firm information prior to inspections, identifying three out of 13 cases that would have resulted in a “washout” had an inspection proceeded and four where no active shipping was occurring;
- Hosting the Global Regulatory Workshop on Plant and Animal Biotechnology Innovation in Brussels, Belgium, the first international regulator-to-regulator dialogue on genome editing; and developing an FDA biotechnology engagement plan and trade strategy with key European counterparts;
- Rolling out the On-Farm Readiness Review (OFRR) International Pilot in Chile, Mexico and Costa Rica in coordination with CFSAN. These programs provide practical on-farm understanding of the theory taught in Produce Safety Training Courses to help those who grow, harvest, pack, and hold fruits and vegetables for U.S. import comply with FDA’s Produce Safety Rule. The OFRR Farm tours visited both pineapple and banana plantations and engaged more than 300 individuals in those countries;
- Hosting a Good Aquaculture Practices and Food Safety workshop in Surat, Gujarat, which involved more than 50 shrimp processors and farmers and engaged more than 300 individuals in these countries. The goal was furthering the institutionalization of food safety for India’s seafood industry;
- Leading the U.S. delegation to the first International Food Safety Conference held by the Food and Agriculture Organization of the United Nations, the World Health Organization and the African Union;
- Developing and implementing new policy positions related to dairy certification, biotechnology, and animal hormones for the trade agreement negotiations with China;
- Strengthening operations and oversight at foreign posts by addressing all observations and recommendations from a 2018 financial internal control assessment;
- Taking steps to help promote our new OGPS brand including the establishment of the new @FDA_Global Twitter handle and a new external monthly newsletter;
- Receiving not one, but two, reports we had commissioned from the National Academies for Sciences, Engineering and Medicine. The first, Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators, discussed among other things the importance of measuring the impact of mutual recognition agreements. The second, Stronger Food and Drug Regulatory Systems Abroad, looked back at the substantial progress in harmonizing global food and drug regulatory systems over nearly a 10-year period and looked forward to possible ways to make these systems even stronger; and
- Finally, participating in FDA’s response to emerging, urgent public health concerns with technical support and engagement with foreign regulators. We did this during the ongoing public health concern involving blood pressure and heart failure medicines known as Angiotensin II Receptor Blockers, during food outbreaks and now as the global public health community strives to flatten the curve of the COVID-19 pandemic.
With these many accomplishments in mind, OGPS is also looking ahead at how the office can grow and improve over the next several years. Soon OGPS will be unveiling an ambitious but ultimately doable 5-year strategic plan that will allow us to leverage our resources and strengthen our programs to more fully achieve our public health mission. All of us in OGPS are looking forward to implementing this plan, as a great way of kicking off our second year as an office.
Mark Abdoo is FDA's Associate Commissioner for Global Policy and Strategy