By: Christopher Hickey, Ph.D.
I love history. I especially love the story of Meriwether Lewis and William Clark who, in their famed venture to explore the newly-purchased Louisiana Territory at the direction of U.S. President Thomas Jefferson, fashioned a lean and mean team largely consisting of seasoned, highly qualified frontiersmen. While Lewis and Clark’s “Corps of Discovery” benefitted to some degree from maps that had been developed by previous explorers who had traversed similar terrain, there was a large swath of territory in the middle of their journey that was literally “off the map”—no non-native groups had ever set foot on those pieces of the North American continent. And while brawny, rough-and-tumble, frontiersmen may have dominated the rolls of the Lewis and Clark expeditionary force, they would have all frozen or starved to death had it not been for the keen and savvy brilliance of Sacagawea, surely one of the unlikeliest heroines in American history.
The Honorable Margaret Hamburg, Commissioner, FDA and Dr. Christopher Hickey, Country Director, FDA China
I also love my job. I run FDA’s China Office. Nearly four years in, I still pinch myself most mornings to make sure I’m actually getting paid to lead this fascinating, unpredictable 21st century expedition to explore new public-health frontiers for my country.
Like Lewis and Clark, we in the FDA China Office have been fortunate enough to benefit from a surfeit of talented “frontiersmen” – and women! – who’ve volunteered for this pioneering venture. They include inspectors and policy analysts who, in some cases, have served FDA for nearly four decades! They’ve seen marked similarities between the challenges we face in China in 2012 and the challenges FDA faced in regulating domestic U.S.industry several decades ago. Our “pioneers” include FDA food scientists and biochemists with deep, rich expertise who are now applying that knowledge to work in collaboration with Chinese authorities as they develop a regulatory system that will keep pace with increasing Chinese economic growth, and ever-expanding exports to U.S.markets. And our “FDA Corps of Discovery” includes legal, policy and health diplomacy professionals. These professionals apply their knowledge of FDA standards and regulations, as well as their scientific and diplomatic expertise, to enhance the Agency’s knowledge base about China’s regulatory landscape. In addition, they track industry trends to inform U.S. regulatory decisions and actions, and strengthen collaboration on mutual regulatory challenges.
And we certainly find ourselves, like Lewis and Clark, “off the map,” at times. How do you navigate a regulatory system that assigns responsibility to government agencies not by product category but by where the product currently sits in the system of production and distribution? How do you engage a regulatory counterpart that has export promotion as a primary mission? How does FDA engage a regulatory system where the legacy of state-owned enterprises still looms large? These are all “off-the-map” types of questions we’ve had to face.
And we have our Sacagaweas—unsung, unlikely public-health heroes. While U.S.civil servants lead the way for our efforts in China, Chinese nationals play a key role to support our work—liaising with the Chinese Government, negotiating cross-cultural communications, and supporting our inspections throughout China. FDA could not do its work in China—or in any of its overseas offices—without dedicated foreign service nationals.
“Those who cannot remember the past are condemned to repeat it,” Spanish philosopher George Santayana once opined. In FDA’s China Office, we strive to remember the best of our past so that we can know how best to engage our emphatically globalized future.
Christopher Hickey, Ph.D., is FDA’s China Country Director