In recent years, drug and device companies have started to operate more clinical trials in South America, which reflects the growing number of clinical trial subjects and sites located outside of the U.S. As American companies seek a more cost-effective environment and larger pools of patients, weighing the clinical data gathered at trials outside of the U.S. is one example of how globalization has affected the responsibilities of the Food and Drug Administration.
Up to 65% of clinical trials for FDA-regulated products occurred outside of the U.S. in 2008, according to a 2010 report from HHS' inspector general's office. The FDA has reported that regulated products now make up about one-tenth of all imports into the U.S. While the issue of how the federal agency regulates an increasingly global market is not new, the release of the Pathway to Global Product Safety and Quality report in July signaled a shift in how the FDA plans to address growing concern about counterfeit or adulterated drugs and an increasingly complex global supply chain. “It's still a domestic mission,” says Dr. Murray Lumpkin, the FDA's deputy commissioner for international programs. “What has changed fundamentally is the ever-increasing number of products that we are seeing from overseas.”
The FDA began posting staff positions outside of the U.S. in 2008, according to Lumpkin, and currently has 50 permanent employees based outside of the U.S., including 33 U.S. citizens and 17 locally employed support staff.
Twenty of those 33 FDA positions are located in China and India. According to the FDA report, medical product exports from these two countries are expected to increase by more than 400% over the next decade.
A Pew Health Group report about substandard and counterfeit drugs found that raw pharmaceutical materials, including materials used to manufacture older and off-patent drugs, exported to the U.S. from China is now a $2.2 billion business. In contrast, FDA operations in Belgium, Chile, England, Italy, Jordan and South Africa are each staffed by one employee.