Q&A for FDA Assistant Commissioner for International Programs Ball
Jun 3, 2013
What was the purpose of your visit here?
This was my first visit to China in my role as Assistant Commissioner for International Programs at FDA, which I assumed last year. Part of my work is to manage FDA’s operations abroad, and ensure they are functioning effectively and efficiently. FDA established its China Office in 2008, with the goal of strengthening our cooperation with Chinese regulatory officials, providing relevant Chinese industry information about FDA requirements, and increasing FDA inspections in China. Since then, FDA has made great strides in deepening its relationship with Chinese counterparts, and increasing its understanding of the Chinese regulatory system for food and medical products in China. As part of our cooperation with our regulatory counterparts, during my visit, I participated in a workshop hosted by the China Food and Drug Administration (CFDA) on FDA’s oversight of human clinical trials for drugs and medical devices marketed in the United States.
Whom did you meet and what were the main outcomes of this meeting?
Dr. Li Jinju, Division Director in the Department of Drug Registration at CFDA, hosted the workshop. Approximately 30 CFDA experts in clinical trials also attended the workshop. From 2003 to 2012, my job at FDA was overseeing clinical investigations of human drug trials. It was clear from the interaction with CFDA that China and the United States face similar challenges in ensuring the integrity of clinical trials for products that have the potential to save the lives of our citizens. I greatly enjoyed the opportunity to share FDA’s experience with our counterparts, and to learn from them what best practices they have developed to address these important issues.
In China, what are the main challenges for U.S.-China joint efforts to improve clinical trial monitoring?
In the area of clinical trials, I think regulators around the world face many of the same issues. Those challenges include concerns for the rights and safety of those who participate in trials; the soundness of the design of the trial; the qualifications of clinical investigators; appropriate monitoring; and accuracy of results. In recent years, FDA has seen more and more clinical trials being performed outside of traditional locations like the United States and Europe. China is an important part of that dynamic.
How do the United States and China cooperate on clinical trial monitoring?
Starting in 2010, experts from FDA began a three-part training program with CFDA, a project that spanned the course of two-and-a-half years. During that project— which used a train-the-trainer approach— we were able to do intensive work with 30 Chinese technical experts and inspectors who will be active in this area for many years to come. First, our experts did traditional classroom training with this cadre. In 2011, the same group came together for mock inspections of clinical trial sites in China, with FDA experts giving guidance and oversight. And in 2012, those same Chinese staff did the training themselves, with FDA experts again providing supervision and oversight. We’ve come a long way with our Chinese colleagues. My visit helped to provide a larger context about FDA’s broader work in this area.
What were the priority issues in your discussions with Chinese counterparts?
I talked with CFDA about the long history we have at FDA—and highlighted both successes and some of our real challenges. In the United States, regulation involving food and drugs often sprang from public health disasters that spurred our Congress to act. We’ve seen similarities here in China, with some of the product safety emergencies in recent years. I also talked with CFDA about our present work, which aims to sustain a comprehensive program of on-site inspections and data audits designed to monitor FDA-regulated research. And I talked with them about our future trajectory, which will include movement towards global coalitions of regulators; development of global data information systems to share real-time information across markets; expansion of capabilities in gathering information about risk; and increased leveraging of the combined efforts of government, industry, and public- and private-sector third parties.