American Shipper

GAO reports show FDA stretched thin

GAO reports show FDA stretched thin

   Two congressional watchdog agency reports released Tuesday detail how the increased volume of food and drug products produced overseas and imported into the United States have stretched thin the resources of the Food and Drug Administration.

   The Government Accountability Office report, FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but more Progress Is Needed, examines FDA's efforts to regulate and provide adequate oversight of foreign drug manufacturing firms that export drug products to the U.S. market. The review also examines whether the agency is prioritizing scarce inspection resources and making needed changes related to how it collects pertinent data about foreign firms that export drug products to the United States.

   GAO found that while FDA has made some progress in closing its inspection gap, the agency still conducts relatively few foreign inspections. For example, FDA inspects about 11 percent of all foreign drug firms exporting to the United States annually. At this rate, it will take FDA about nine years to inspect each of these firms one time. In contrast, FDA inspects each domestic U.S. drug manufacturer firm about once every 2.5 years.

   GAO in earlier reports has recommended FDA create a risk-based inspection system to better prioritize its scarce inspection resources.    The agency has yet to fully adopt that recommendation resulting in the potential misapplication of critical resources, GAO noted in its report.

   'Given that foreign firms are increasingly the source of many medicines now consumed by Americans, FDA needs to continue to explore way to better enhance its foreign inspection efforts, particularly for high risk products,' said House Oversight and Government Reform Committee Chairman Edolphus 'Ed' Towns, D-N.Y., in a statement regarding the release of the GAO reports. 'It is troubling to learn that a foreign plant making a drug product for the U.S. market is inspected far less frequently than a domestic plant.'

   The second GAO study released, Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning is Needed, examines the FDA's efforts to establish overseas offices to enhance its ability to work with foreign governments to inspect and monitor food products, medical devices, and drug products sent to the United States. Food production for the U.S. market, like for medicine, has increasingly shifted overseas over the past decade. This also has posed considerable new challenges for the agency.

   From late 2008 to early 2009, FDA opened offices, comprising 42 total staff, in China, Europe, India, Latin America and the Middle East.

   GAO's study found that while the impact of the overseas offices on the safety of imported products is not yet clear, they have provided other benefits that may help protect U.S. consumers in the long run.    For example, the permanent overseas offices allow FDA to establish important regulatory dialogue with their foreign counterparts and permit the agency to gather data about regulated products. Additionally, FDA field officials have conducted more inspections and are helping export countries to develop their own regulatory systems.

   However, GAO found that coordination of FDA's foreign offices with other parts of the agency remains a challenge and that it lacks a long-term strategic plan for how these offices will continue to function.    Without this plan, GAO raised concerns that it would be difficult to assess how this FDA program benefits U.S. consumers, and whether the current setup optimizes FDA's limited inspection resources.

   'With the avalanche of products consumed in America now coming from overseas, I applaud FDA's efforts to step up their foreign presence with these new offices,' Towns said. 'Nonetheless, where they are strategically located and what they accomplish towards protecting the consumer should be closely monitored over the coming years to ensure their costs can be justified.' ' Chris Gillis