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More Foreign Drug Establishment Inspections Being Done but Effect on Safety Unclear

Monday, January 23, 2017
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has made “important strides” in responding to the challenges that globalization poses to ensuring the safety of the U.S. drug supply but additional progress is needed, according to a recent report from the Government Accountability Office.

More than 40 percent of finished drugs and 80 percent of active pharmaceutical ingredients are produced in registered establishments in more than 150 countries, the report states. The FDA inspects these establishments to ensure that the safety and quality of drugs are not jeopardized by poor manufacturing practices, and beginning in 2008 the agency established foreign offices to obtain better information on products coming from overseas and perform inspections.

Since then, the report states, the FDA has increased its foreign drug establishment inspections and enhanced its ability to prioritize establishments for inspection. The number of foreign inspections has consistently increased, from 440 in fiscal year 2010 to 842 in FY 2015, when it exceeded the number of domestic inspections for the first time. The FDA is also using a single risk-based model to prioritize foreign and domestic drug establishments to inspect and has reduced its catalog of foreign establishments with no inspection history to 33 percent, down from 64 percent in 2010. While the FDA plans to inspect the rest, numbering nearly 1,000, over the next three years, the GAO notes that this “knowledge gap” is an issue the agency has been aware of since at least 1988.

The FDA has also made progress in strategic planning for its foreign offices, the report adds, but has yet to determine if those offices meaningfully contribute to drug safety because it has no formal process for making such assessments. The agency uses two performance measures to assess foreign offices – number of medical product inspections and number of collaborative actions – but the latter does not capture the offices’ unique contributions to drug safety.

Moreover, the FDA’s foreign offices face persistently high vacancy rates, with 46 percent of authorized positions empty as of July 2016. The FDA recently finalized a strategic workforce plan for these offices but the GAO notes that it does not address some of the reasons for the high vacancy rates.

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