FDA Lacks Inspection Data on Almost 1,000 Foreign Drug Firms Shipping to U.S.

FDA Has Improved Foreign Drug Inspection Program, but Lacks Performance Assessment of Understaffed FDA Foreign Offices

U.S. House Committee on Energy and Commerce: The non-partisan Government Accountability Office (GAO) today issued a new report acknowledging that while the U.S. Food and Drug Administration (FDA) has made some important improvements to its foreign drug inspection program, there are still serious data gaps on foreign drug firms shipping finished drug products and active drug ingredients to the United States. GAO also identified that additional work also needs to be done to better assess the effectiveness and staffing of FDA’s foreign offices, noting that 46 percent of the positions at the FDA foreign offices are vacant and that the vacancies have been a persistent problem.

Among the areas of improvement, the GAO found that FDA has increased its foreign drug inspections and improved their mechanisms for doing so, including the accuracy of the catalog of drug facilities subject to inspection.

GAO summarized their findings, saying, “It has also reduced its catalog of drug establishments with no inspection history to 33 percent of foreign establishments, compared to 64 percent in 2010. However, the number of such establishments remains large, at almost 1,000 of the approximately 3,000 foreign establishments.”

These findings show that the FDA has not resolved the data gap deficiency found by GAO when the FDA inspection program was previously examined in 2010. With 80 percent of U.S. drug ingredients coming from abroad and nearly 40 percent of finished U.S. drugs made overseas, there is reason for concern. This data gap is also of significance because for the first time in FDA history, the agency conducted more foreign drug inspections than domestic inspections in FY 2015.

“The FDA has made some significant improvements over the last 10 years to their handling of the foreign drug inspection program, but more work lies ahead,” said Energy and Commerce Committee Chairman Greg Walden (R-OR) and Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ). “The gap in foreign drug firms that the FDA has no information on is sizeable and very troubling. Critical work remains, and with these recent improvements, I’m/we’re encouraged that these milestones can be reached.”

In 2008, GAO reported that the rate of foreign inspections was alarmingly low. For example, in a September 2008 report, GAO found that on average, the agency had only conducted about 247 inspections per year from 2002 through 2007. Today’s report, however, indicates that considerable progress has been made by the agency in increasing the number of foreign inspections, with 842 inspections conducted in 2015.

Eight years ago, FDA established foreign offices around the world that would have great potential to improve the quality and timeliness of foreign drug inspections. However, GAO found that FDA has not assessed its foreign offices’ contributions to drug safety, which is inconsistent with federal standards for internal controls. Accordingly, GAO recommended FDA assess their foreign offices to establish a goal on addressing the vacancy rates in those offices as well as their domestic international program office.

To view a copy of the GAO report, click HERE.

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