Plagued with recent major contamination cases associated with food and
medication importation, the Food and Drug Administration (FDA) hopes overseas
offices it is opening in China, India, Europe, Latin America, and the Middle
East will improve quality control of imported products and prevent future
The FDA announced on November 18, 2008, that offices were being opened in
Beijing, Shanghai, and Guangzhou, China. Eventually eight U.S. staff members
and five local hires will be posted in China. In addition, the first European
office was opened in Brussels on December 3, 2008, followed by the first
office in Latin America, on January 7 in Costa Rica. The first offices in
India were opened in New Delhi and Mumbai on January 15, with the expectation
of a total of 12 U.S. staff to be posted. Additional offices are planned for
By the end of Fiscal 2010 (September 30, 2010), the FDA expects to post a
total of 43 full-time U.S. nationals and 20 locally employed staff at the
overseas offices, Christopher Kelly, an FDA spokesperson, told Psychiatric
News. These personnel will include inspectors and technical experts in
medicines, medical devices, and foods.
The agency wants to "build or further strengthen a trusted
regulator-to-regulator relationship, more easily inspect manufacturing and
processing facilities in these countries, or ... leverage inspections already
performed by its counterparts" and "verify that imported products
and the way they are manufactured meet U.S. health and safety
requirements," according to the FDA.
The agency has come under intense criticism in recent years for failure to
inspect and stop importation of contaminated food and drug products at U.S.
borders. In early 2008, a massive recall of contaminated heparin products sold
by Baxter was traced to a bulk active-pharmaceutical ingredient manufactured
in China, prompting a congressional hearing. By April 21, 2008, 81 deaths were
attributed to the contaminant in the heparin products, according to an FDA
assessment, and many people suffered serious allergic-type hypersensitivity
reactions and severe hypotension.
Last September the agency issued an import alert for certain medications
manufactured by Ranbaxy, an India-based company, citing deviations from U.S.
manufacturing standards at two of its facilities in India. More than 30
generic drugs were covered in the alert and were subject to being detained at
border entry. No product was recalled.
A report by the Government Accountability Office (GAO) released in June
2008 found the FDA to be ill-equipped to track, manage, and conduct thorough
and timely inspections of all manufacturers that produce imported drugs.
The FDA databases contained "inaccurate information on foreign
establishments" manufacturing drugs imported to the United States,
according to the report. Notably, the "FDA does not know the number of
establishments subject to inspection," it concluded. Two different FDA
databases recorded 3,000 and 6,800 establishments that have registered with
the agency to import drug products into the United States, possibly because of
duplicate records. These foreign establishments reported manufacturing a wide
range of products including human medications, biologics, and veterinary
drugs. However, the "FDA was unable to determine from this database the
number of registered establishments specifically manufacturing human
drugs," the report stated.
In Fiscal 2007 (from October 2006 to September 2007), the countries with
the most registered establishments in the databases were China, India, Canada,
France, and Germany.
From 2002 through 2007, the FDA inspected 1,479 foreign drug-manufacturing
establishments, equivalent to inspecting 8 percent of them annually, the GAO
estimated. "At this rate, it would take the agency more than 13 years to
inspect [every] establishment once."
The report also criticized the lack of timely follow-up inspections of
foreign manufacturers that have been found to have serious problems. From 2002
to 2007, the FDA issued 15 warning letters to foreign manufacturing plants
because of serious deficiencies, but subsequently inspected just four for
compliance two to five years after the warning.
In the heparin incident, FDA officials admitted that they had failed to
inspect the Chinese plant implicated in the contamination. When the agency
finally inspected the facility in February 2008, there were so many
deficiencies that the plant was barred from exporting any product to the
The GAO released another report in January 2008 on the FDA's inspections of
medical-device manufacturers, which was critical of the FDA's capacity to
ensure the manufacturing standards are met for domestic as well as foreign
"Inspections of foreign medical-device manufacturing establishments
pose unique challenges to FDA in human resources and logistics," the
As importation of all types of goods continues to rise, whether these newly
established foreign FDA offices will improve the quality control of imported
medications to match domestic standards is unknown, the GAO concluded. These
offices will be overseeing foreign manufacturers of not only drug ingredients
and products but also imported food and other products under FDA
The GAO estimated that inspection of every foreign manufacturing plant
every two years, as is required for domestic-site inspection, would require a
budget increase of $67 million to $71 million annually. The FDA's budget for
foreign inspection was $11 million in Fiscal 2008. To initiate the overseas
offices in the five regions, the FDA has a budget of about $20 million for the
cost of personnel, startup, and initial capacity building, Kelly said.
As part of an import-safety initiative by the federal government, the FDA
says it plans to recruit and certify third parties to verify that foreign
manufacturers conform to U.S. safety standards and requirements before their
products can be imported. These third-party resources may include
foreign-government agencies and accredited independent organizations.
One of the goals of these overseas FDA offices is to establish the"
capacity to perform more overseas inspections in a more timely manner
and expand inspection capacity through direct, trusted [foreign agency]
counterparts and third parties," Kelly noted. The reliability of these
third-party inspectors will then be confirmed through FDA audits.
"Drug Safety: Better Data Management and More Inspections Are
Needed to Strengthen FDA's Foreign Drug Inspection Program" is posted at<www.gao.gov/products/GAO-08-970>."
Medical Devices: Challenges for FDA in Conducting Manufacturer
Inspections" is posted at<www.gao.gov/new.items/d08428t.pdf>.
Information about the FDA's overseas offices is posted at<www.globalhealth.gov/index.html>.
The action plan for improving import safety is posted at<www.importsafety.gov>.▪