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More Foreign Drug Inspections “Urgent” but Few Being Done by Overseas FDA Offices

10/27/10

Source: WorldTrade Interactive
Related Topics: Government Agencies

Two Government Accountability Office reports released this week assert that there is an “urgent” need for more inspections of foreign drug manufacturers but that the Food and Drug Administration’s overseas offices are not yet making a significant contribution to the agency’s ability to conduct those inspections.

GAO states that while FDA has increased the number of foreign drug inspections it still conducts relatively more inspections of domestic facilities than those overseas. FDA’s foreign drug inspections rose from 333 in fiscal year 2007 to 424 in FY 2009, or about 11% of foreign establishments prioritized for inspection. By comparison, FDA conducted 1,015 domestic inspections in FY 2009, or approximately 40% of all domestic establishments.

The report further points out that FDA’s approach in selecting establishments for inspection is inconsistent with GAO’s 2008 recommendation that those establishments with the greatest public health risk potential should be inspected at a comparable frequency if they experience a manufacturing defect, regardless of whether they are foreign or domestic. Instead, FDA’s foreign inspections continue to be driven by the establishments listed on applications for new drugs instead of those already producing drugs for the U.S. market.

While FDA agreed that more progress is needed to safeguard the U.S. drug supply, it also underscored that relying solely on inspections is insufficient to meet this goal, particularly considering that due to globalization and outsourcing the drug supply chain has become more nebulous and complex. FDA emphasized that for inspections to be effective they must be informed by relevant data from other sources.

The report acknowledges that FDA is taking steps to improve the information it receives from the drug establishment registration and import databases used to manage its foreign drug inspection program and is also exploring other options for obtaining better information, such as collaborating with foreign regulatory authorities to exchange information about planned inspections and the results of completed inspections. However, more than a decade after GAO first raised warnings on this issue, FDA’s efforts appear to involve long-term initiatives that are still only in their early stages. Given ongoing increases in the volume of imported drugs and the number of foreign establishments manufacturing them, the report states, there is an “urgent need” for FDA to better protect the public health by implementing GAO’s prior recommendations.

Unfortunately, according to a separate report, the overseas offices FDA has opened in recent years are not yet making a substantial contribution to the inspection of foreign drug facilities. While these offices have been used to inspect facilities that export food, drugs and medical products to the U.S., as of June 2010 they had conducted only 48 inspections in China and India. This compares to 132 such inspections by U.S.-based staff, which still conduct the majority of foreign inspections, particularly of drug establishments. It is therefore unclear, the report concludes, what impact FDA’s foreign offices have had on the safety of imported products.

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