Report finds FDA still falling short on overseas drug inspections

Tablets_pills260.jpgThe US Food and Drug Administration (FDA) needs to make more progress inspecting drug manufacturing facilities outside the US, and improve on the data it uses to manage them, according to a US government report released on 26 October.

Highlights of the report, by the Government Accountability Office (GAO)—- the investigative arm of the US Congress are available here.

The GAO found that FDA is inspecting more overseas facilities since GAO last weighed in on the issue in this 2008 report. Still, the GAO wrote, at the rate that FDA inspected internatoinal drug plants in 2009, when it conducted 424 such inspections, it will assess any given facility, on average, only once every nine years. In China, which accounts for about a quarter of all the overseas drug manufacturing plants on FDA’s list, the 2009 rate of inspection was once every 18 years. By contrast, in the same year, the agency inspected about 40% of US-based drugmaking establishments, meaning that these domestic facilities are inspected about once every 2.5 years.


The issue is highly relevant, the report points out, because of the increasing number of foreign facilities and the growing volume of imported drugs in the US. (The most recent such drug to make headlines was the sodium thiopental used to execute the convicted murderer Jeffrey Landrigan in Arizona yesterday, as the New York Daily News reported.)

The GAO also complained that FDA continues to prioritize inspections of overseas drug plants that are applying to market a new drug in the US, instead of following GAO’s advice to the agency in 2008. Then, it recommended that FDA focus on inspecting plants among those already producing drugs for the US market that present the greatest public health risks — whether those plants are foreign or domestic.

The Department of Health and Human Services (HHS), which is HHS’s parent agency, reviewed the new GAO report and agreed that FDA needs to make more progress to keep Americans safe in the increasingly global drug marketplace.

The FDA, which received $2.4 billion in government funding in 2010, also came under fire this spring from the HHS Inspector General. The IG issued a report that found “significant weaknesses” in the agency’s inspections of domestic food facilities.

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