FDA Opens Overseas Offices, but Will Safety Improve?

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 United States.

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 establishments.

“Inspections of foreign medical-device manufacturing establishments pose unique challenges to FDA in human resources and logistics,” the report concluded.

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 jurisdiction.

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>.▪