Report Card: Is the FDA Meeting the Mark in Inspecting Foreign Drug Manufacturing Facilities?

Using a risk-based inspection scheme, the US Food and Drug Administration has made bringing to parity inspections of domestic and foreign drug-manufacturing facilities. So how has the agency fared?

A recent report by the Government Accountability Office says that the US Food and Drug Adminstration (FDA) has made progress but further progress is needed. Beginning in fiscal year 2015, the FDA conducted more foreign than domestic inspections, but the agency still has a backlog of more than 1,000 foreign facilities that have yet to be inspected and is facing difficulties in filling staffing in offices outside the US. DCAT Value Chain Insights takes an inside look.

FDA inspections: domestic versus foreign manufacturing facilities
A recent study by the US Government Accountability Office examined the FDA’s efforts in inspecting domestic and foreign drug-manufacturing facilities. Approximately 40% of finished drugs and 80% of active pharmaceutical ingredients are produced overseas, according to the FDA, and beginning in 2008, the FDA established foreign offices to obtain better information on products coming from overseas and to perform inspections, among other things. In 2008 and 2010, the GAO examined FDA’s foreign drug inspection program and recommended it conduct more foreign inspections. In another 2010 report, the GAO recommended the agency develop strategic and workforce plans for its foreign offices. The GAO was asked to update its work with a focus on FDA’s oversight of foreign drug establishments. This current report examines: (1) enhancements FDA has made to its foreign drug inspection program; and (2) FDA’s assessment of its foreign offices and the challenges they face in ensuring drug safety. The GAO analyzed FDA’s inspection data from fiscal year 2007 through June 30, 2016, reviewed agency planning documents, and interviewed FDA officials, including former foreign office employees. The GAO recommends that the FDA assess the contributions of the foreign offices and set a goal that distinguishes between the vacancy rates of staff in its foreign offices and those in its domestic international program office, a recommendation agreed to by the US Department of Health and Human Services, which oversees the FDA.

The GAO report found that the FDA has increased the number of inspections of foreign drug-manufacturing facilities. The number of foreign inspections has consistently increased each year since fiscal year 2009 (see Table I at end of article). Beginning in fiscal year 2015, FDA conducted more foreign than domestic inspections. FDA has also improved the accuracy and completeness of information on its catalog of drug establishments subject to inspection. It has also reduced its catalog of drug establishments with no inspection history to 33% of foreign establishments, compared to 64% in 2010. However, the number of such establishments remains large, at almost 1,000 of the approximately 3,000 foreign establishments, according to the GAO report. Per the GAO report, FDA said it plans to inspect all of these establishments over the next three years

A key finding by the report is that the FDA needs to do more to improve the inspection process for foreign drug-manufacturing facilities. The report says that the FDA has not yet assessed its foreign offices’ contributions to drug safety. “The FDA has made progress in its strategic planning for its offices in China, Europe, India, and Latin America, but the lack of an assessment is inconsistent with federal standards for internal controls,” says the report. Alhough the FDA uses two performance measures to assess the foreign offices—number of medical product inspections and number of collaborative actions—the collaborative action measure does not capture the offices’ unique contributions to drug safety, concludes the report. The report also notes that the foreign offices face persistently high vacancy rates. As of July 2016, 46% of the foreign offices’ authorized positions were vacant. Although FDA recently finalized a workforce plan, the GAO identified several weaknesses with it. For example, the plan sets a workforce target that applies to both foreign and domestic international program offices, making itmaking it difficult to ascertain whether its goal of reducing foreign office staff vacancies is being met.

Table I: Total Number of US Food and Drug Administration Inspections of Domestic and Foreign Drug Establishments, Fiscal Year 2007 through June 30, 2016. Source: US Government Accountability Office
Fiscal Year Number of Domestic Drug Establishments Inspected Number of Foreign Drug Establishments Inspected
2007 1,122 333
2008 1,033 324
2009 1,015 424
2010 1,248 440
2011 1,254 559
2012 1,183 625
2013 1,033 636
2014 897 779
2015 787 842
2016 (through June 30, 2016) 432 503


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