FDA looks at overseas trials
FDA sends staff overseas to help monitor imports
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 costeffective 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.
Lumpkin says the overseas FDA employees—only a small portion are inspectors—work closely with exporters, as well as with other federal agencies such as the Agriculture and Justice departments and Customs and Border Protection. Inspection is a small part of what FDA staff is responsible for overseas, he says. Other tasks include monitoring the local regulatory and political arena, environmental scanning, gathering information to inform decisions to allow products into the U.S., and interacting with counterpart agencies within the region.
Globalization also has led to changes in how companies operate. Over the past couple of years, U.S.-based companies that operate manufacturing facilities abroad or buy raw materials from vendors outside of the U.S. have started to place employees in foreign plants for limited or extended periods of time, says Linda Bentley, a lawyer with Mintz, Levin, Cohn, Ferris, Glovsky and Popeo in Boston and chair of the firm’s FDA practice.
In those cases, employees support quality efforts by conducting inspections and testing products, rather than solely relying on a certificate of analysis, a document provided by a supplier that certifies the materials.
U.S.-based companies are increasingly seeking to cut costs by outsourcing the purchase of raw materials and manufacturing to emerging markets. According to the FDA, the cost of formulation of an active pharmaceutical ingredient can cost up to 40% less in India compared with the same ingredient in the U.S.
“American manufacturers are looking overseas for less expensive sources of products,” Bentley says. “The primary driving force is the price and business consolidation.”
While U.S.-based companies have longestablished manufacturing and research and development facilities overseas, reducing costs and increasing productivity remain priorities.
Some drugs and devices made in Ireland— which has served as an entry point for American companies in the European Union for decades, in part because there is no language barrier— are imported in the U.S., says Barry Heavey, vice president of , technology marketing for Irish investment promotion agency IDA Ireland. About 40 medical technology companies with headquarters in the U.S. have manufacturing facilities in Ireland, including Abbott Laboratories, Baxter, Becton Dickinson & Co., and Medtronic, according to IDA Ireland.
“While a large portion of U.S. medical product imports have historically come from Western Europe, there are indications of a shift,” according to the FDA report. “Import lines from emerging markets, including Mexico, India, China and Thailand increased faster between 2002 and 2009 than lines from developed markets, and this disparity is likely to continue.”
As more manufacturers in emerging markets are exporting products to the U.S. subject to FDA regulation, the agency argues that creating a coalition of regulators from around the globe is needed to support changes in the international trade of medical products.