- Speech by
(Remarks as prepared for delivery)
I want to start by thanking the DIA, DIA China, Carol Zhu, Barbara Kunz, and the organizers of this event. It is an honor to be addressing you.
Ladies and gentleman, distinguished guests, today I want to share with you information about changes to FDA’s international office. Recently, FDA reorganized our Commissioner’s Office to make its structure more modern and efficient, to better meet the challenges of the dynamic environment in which we are working, and to promote better collaboration across commodities and policy areas.
In the reorganization, FDA’s Office of International Programs was augmented and redesigned to become a new Office of Global Policy and Strategy, which I lead.
We have organized this new office into three subdivisions: the Offices of Diplomacy and Partnerships, Global Operations, which includes our foreign posts, and Trade, Mutual Recognition and International Arrangements.
Its structure rebalances the office, elevating diplomacy and the wide scope of policy work that the office performs, while maintaining our overseas footprint and enhancing the important work, including inspections and investigations, performed at our foreign posts.
So, what is the mission of this new Office of Global Policy and Strategy and what will it do? The Office of Global Policy and Strategy is intended to promote and protect the public health of Americans by ensuring global considerations are fully integrated into the Agency’s policies and operational activities. It will do so in a number of ways:
First, through policy coherence. OGPS will promote mutually reinforcing policy actions to advance FDA’s public health and regulatory interests globally.
Second, through the development of global partnerships. These partnerships will improve compliance with FDA requirements, enhance the capacity of foreign regulatory partners to conduct inspections and laboratory analyses, increase global understanding of the links between strong, well-functioning regulatory systems and public health, economic development, and global trade in goods, and support regulatory alignment.
Third, through the collection, analysis and sharing of high-quality information, including inspection data, to advance FDA’s public health mission. In doing so, we will enhance our risk-based management of regulatory resources, improve our oversight, increase our understanding of complex global supply chains and their effects on the safety and quality of products we regulate, and strengthen capacity to detect and remove violative products and mitigate public health risks through regulatory actions.
FDA views this reorganization as a critical step in further elevating its international endeavors, ensuring that this work is fully integrated into and across the agency’s strategic engagements and key policy initiatives.
These changes are occurring at a time when the importance of our global policy and strategy has never been greater since our public health mission must increasingly be international in scope.
Global production of FDA-regulated goods, components or ingredients has become an everyday reality - 35 percent of medical devices are imported to the U.S. and 80 percent of the FDA-registered manufacturers of active pharmaceutical ingredients (API) are located outside of the United States.
With more than 150 countries exporting FDA-regulated products to the United States, FDA must work beyond U.S. borders to ensure that products coming into the United States are safe and effective since many of these nations have less developed regulatory systems than ours.
These are also profound trends for manufacturers who must cope with greater numbers of suppliers, more complex products, multinational supply chains, more products sourced from developing countries and emerging markets – and regulators of varying capacities.
Establishing foreign offices is another important way FDA has worked to protect patients and consumers from unsafe products entering our U.S. borders. We began with an office in Beijing 10 years ago and today maintain foreign offices in Belgium, Chile, China, Costa Rica, India and Mexico, and have embedded a staff person into the European Medicines Agency.
Here in China, our staff not only support inspections but also provide stakeholders, including local companies with hands-on training and real-time feedback on how to meet FDA’s regulatory requirements, engage with Chinese regulatory authorities on regulatory systems strengthening and information sharing, and closely monitor and report on conditions, trends, and events that could affect the safety, quality, and effectiveness of FDA-regulated imports.
Our world is not becoming smaller – quite the opposite. It is clear that we must continue to build on our current efforts so our regulatory frameworks are modern and efficient while protecting the public health regardless of where a product is produced.
I am looking forward to leading the global work at FDA and thank the organizers for the opportunity to participate today.