GAO Says FDA Urgently Needs to Increase Foreign Drug Facility Inspections
The Government Accountability Office has written two related reports on the Food and Drug Administration’s inspection of foreign drug establishments and on the effectiveness of its overseas offices in ensuring import safety. Though the reports note certain progress, GAO states that FDA urgently needs to increase foreign drug establishment inspections and strengthen the data it uses for its inspection program.
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FDA Only Inspects 11% of Foreign Drug Facilities Yearly vs. 40% of Domestic
GAO states that FDA increased the number of foreign drug inspections it conducted from fiscal year 2007 to 2009 by 27%, but it still conducts relatively fewer foreign drug inspections each year than it conducts domestically. For example, in 2009, FDA inspected 1,015 domestic drug establishments on its list or 40% of them, but it only inspected 424 foreign drug establishments or 11% of those on its list.
At Current Pace, Need 9 Years to Investigate all Foreign Drug Establishments
At these rates, GAO estimates it would take FDA about 9 years to inspect all foreign establishments on its list one time, compared to only 2.5 years for domestic establishments.
GAO Has Suggested Inspecting All High Risk Establishments at Same Rate, Etc.
GAO states that FDA’s approach in selecting establishments for inspection is inconsistent with GAO’s 2008 recommendation that FDA inspect, at a comparable frequency, those establishments that are identified as having the greatest public health risk potential if they experience a manufacturing defect, regardless of whether they are a foreign or domestic establishment. Instead, its foreign inspections continue to be driven by the establishments listed on an application for a new drug, instead of those already producing drugs for the U.S. market.
In addition, GAO reported in 1998 and in 2008 that FDA not only needed to conduct more inspections of foreign establishments but that it was vital that the agency strengthen the data it uses to manage its foreign drug inspection program.
FDA Has Not Addressed Weaknesses, Despite Rising Drug Imports
While FDA has begun to respond to GAO’s recommendations, it has not yet fully addressed these weaknesses at a time when the volume of imported drugs and the number of foreign establishments producing these drugs have been increasing. Given the long-standing nature of these challenges and the U.S. reliance on drugs manufactured overseas, GAO states that is urgent that FDA implement its prior recommendations to better protect public health.
FDA Agrees More Progress is Needed
According to GAO, FDA’s Department of Health and Human Services reviewed a draft of its reports and agreed that more progress is needed in order to meet the challenge of safeguarding the U.S.’ drug supply in today’s global marketplace.
(See ITT’s Online Archives or 10/28/08 and 05/12/08 news, 08102825 and 08051230, for BP summaries of a 2008 GAO report on FDA’s Foreign Drug Inspection Program and GAO testimony on FDA initiatives to improve the program.)
Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed, GAO-10-961, dated September 2010, available here.
Food and Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed, GAO-10-960, dated September 2010, available here.